Administration
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R5
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Orders
and
Observations
Work
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|
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Security Category : Anonymous | Compartments : No defined compartments |
The
characteristics,
operational
status
and
capabilities
definition
of
a
medical-related
component
kind
of
device
or
device
component.
Typically,
this
definition
corresponds
to
a
medical
device
model
although
it
may
be
a
broader
category
of
device.
Devices
include
durable
(reusable)
medical
equipment,
implantable
devices,
as
well
as
disposable
equipment
used
for
diagnostic,
treatment,
and
research
for
healthcare
and
public
health,
as
well
as
devices
such
as
a
machine,
cellphone,
computer,
software,
application,
etc.
The
DeviceDefinition
resource
is
used
to
describe
the
common
characteristics
and
capabilities
of
a
device
of
a
certain
type
or
kind,
e.g.,
a
certain
model
or
class
of
a
device
such
as
a
x-ray
model
or
personal
wearable
device
model,
whereas
a
Device
resource
documents
an
actual
instance
of
a
device
such
as
the
actual
x-ray
machine
that
is
installed
or
the
personal
wearable
device
being
worn.
Devices
include
durable
(reusable)
medical
equipment,
implantable
devices,
as
well
as
disposable
equipment
used
for
diagnostic,
treatment,
and
research
for
healthcare
and
public
health,
as
well
as
devices
such
as
a
machine,
cellphone,
computer,
software,
application,
etc.
Devices
can
also
be
subdivded
as
follows:
subdivided
into
the
following
categories:
'Active
device'
means
any
device,
the
operation
of
which
depends
on
a
source
of
energy
other
than
that
generated
by
the
human
body
for
that
purpose,
or
by
gravity,
and
which
acts
by
changing
the
density
of
or
converting
that
energy.
Devices
intended
to
transmit
energy,
substances
or
other
elements
between
an
active
device
and
the
patient,
without
any
significant
change,
shall
not
be
deemed
to
be
active
devices.
Software
shall
also
be
deemed
to
be
an
active
device.
MDR
(EU)
2017/745
Active Implantable Medical Devices include the definition for both active devices and implantable devices (see below). Examples include: Implantable cardiac pacemakers; Implantable defibrillator; Implantable neurostimulator systems; Leads, electrodes, adaptors for implantable pulse generators; Brachytherapy systems; Ventricular Assist Devices (VADs); Cochlear implants; Implantable infusion pumps; Implantable glucose monitors; Micro Electro-Mechanical Systems (MEMS); and their accessories where applicable.
This category of devices communicates electronically to peer information systems or possibly another device. In addition to patient observations for use by clinicians in providing care and for building a health record, the device communicates metadata about its own state and the protocol used to transfer that information.
To support the use and evaluate the reliability of the patient data, it is important to collect and record data about the identity and operational status of the device that generated the observations. The Device resource is an important locus for such information. The information it generates for clinical and other purposes goes into other resources such as the Observation or Medication resource depending upon what the device does. To support device-related information about Communicating Medical Devices the Device resource needs to have elements that describe not only the basic information like the serial number, manufacturer name and model number, but information about the protocol, its version, its certification, the properties it has to perform its purposed tasks such as internal clocks, synchronization state, resolution, etc.
Equipment and supplies that provide therapeutic benefits to a patient in need because of certain medical conditions and/or illnesses, and which are ordered by a health care provider for everyday or extended use.
Examples include: oxygen equipment, suction pumps, traction equipment, home infusion services, continuous positive airway pressure (CPAP) devices, hospital beds, wheelchairs, crutches walkers, canes, or blood testing strips and meters for diabetics.
A home use medical device is a medical device intended for users in any environment outside of a professional healthcare facility (although that does not preclude such devices being used in a professional healthcare facility).
Implant
means
a
device
that
is
placed
in
into
a
surgically
or
naturally
formed
cavity
of
the
human
body…for
body.
A
device
is
regarded
as
an
implant
for
the
purpose
of
this
part
only
if
it
is
intended
to
remain
implanted
continuously
for
a
continuous
period
of
30
days
or
more
US
Food
and
Drug
Administration
Center
for
Devices
and
Radiological
Health.
Home
Use
Devices.
more,
unless
the
Commissioner
determines
otherwise
to
protect
human
health.
21CFR
Part
860.3
Accessed
13
March
2020.
12
May
2022
'Implantable
device'
means
any
active
medical
device
device,
including
those
that
are
partially
or
wholly
absorbed
(i.e.,
a
bioresorbable
substance
which
is
intended
taken
in
or
degraded)
by
the
body,
which
is
intended:
by
medical
clinical
intervention
into
a
natural
orifice,
and
which
is
intended
to
remain
in
place
after
the
procedure.
Any
device
intended
to
be
partially
introduced
into
the
human
body
by
clinical
intervention
and
intended
to
remain
in
place
after
the
procedure
BSI
Group.
Active
for
at
least
30
days
shall
also
be
deemed
to
be
an
implantable
medical
devices.
device;
MDR
(EU)
2017/745
Accessed
13
March
2020.
12
May
2022
In vitro diagnostics (IVD) are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases or other conditions, and can be used to monitor a person 's overall health to help cure, treat, or prevent diseases.
In vitro diagnostics may also be used in precision medicine to identify patients who are likely to benefit from specific treatments or therapies. These in vitro diagnostics can include next generation sequencing tests, which scan a person 's DNA to detect genomic variations.
Some
tests
are
used
in
laboratory
or
other
health
professional
settings
and
other
tests
are
for
consumers
to
use
at
home.
US
Food
and
Drug
Administration
Center
for
Devices
and
Radiological
Health
In
Vitro
Diagnostics
and
Drug
Administration
Center
for
Devices
and
Radiological
Health
In
Vitro
Diagnostics
Accessed
12
May
2022
Patient-use
(also
known
as
personal
health
device),
or
home
use
devices,
intended
for
users
in
any
environment
outside
of
a
professional
healthcare
facility.
This
includes
devices
intended
for
use
in
both
professional
healthcare
facilities
and
homes
US
Food
and
Drug
Administration
Center
for
Devices
and
Radiological
Health.
Home
Use
Devices.
Accessed
13
March
2020.
Personal
Health
Devices
(PHDs)
are
the
subset
of
patient-use
devices
that
report
their
information
to
a
peer
via
a
protocol.
One class of communicating devices is the Personal Health Device or PHD. PHDs are medical devices that can be used by patients or others who are typically not medical professions, to gather patient observations and information. These devices can often be purchased in department stores or online by anyone. They may be regulated as medical devices, or not.
PHDs
include
the
popular
fitness
trackers
often
combined
with
heart
rate
monitors,
but
also
blood
pressure
monitors,
weight
scales,
pulse
oximeters,
thermometers,
and,
for
those
that
require
them,
glucose
meters.
Over
time
more
sophisticated
devices
such
as
continuous
glucose
monitors,
insulin
pumps,
vital
signs
monitors
including
ECGs,
and
even
spirometers
are
entering
the
PHD
consumer
market.
These
devices
communicate
measurement
data
and
data
about
themselves
via
a
digital
transport
protocol
to
some
peer
entity,
often
a
mobile
phone
or
tablet.
The
DeviceDefinition
resource
contains
protocol
may
follow
a
standard
but
most
protocols
are
proprietary.
In
either
case,
it
is
common
practice
for
manufacturers
to
provide
free
applications
that
run
on
these
mobile
platforms
for
the
"catalog"
definition
purpose
of
communicating
with
their
devices.
The
fields
populated
in
the
Device
resource
by
PHDs,
typically
via
a
device
-
whether
that
definition
gateway,
is
authored
the
information
a
PHD
reports
about
itself
electronically.
There
is
no
input
by
the
manufacturer
patient
except
for
information
the
patient
may
enter
on
the
device
through
some
UI.
This
device
reporting
capability
distinguishes
communicating
PHDs
from
the
general
set
of
patient-use
devices.
Point-of-care medical devices (PoCD) are intended for use by qualified professionals. PoCDs are typically found at the patient's bedside and convey measurements and supporting data to receiving systems for use in electronic medical records, clinical decision support, and medical data archiving for aggregate quality measurement and research purposes.
PoCDs
are
of
another
level
of
complexity
compared
to
PHDs:
they
include
devices
like
multi-parameter
physiological
patient
monitors,
anesthesia
workstations,
infusion
pumps
and
numerous
other
kinds
of
devices
that
provide
near-real-time
information
about
patient
condition
or
therapy,
potentially
including
dozens
or
hundreds
of
variables
coming
from
a
regulatory
entity
and
allows
defining
valid
hierarchical
single
device
configurations
(devices
system.
They
may
be
structurally
complex,
involving
multiple
subsystems
that
are
themselves
complex,
such
as
part
of
other
devices).
a
ventilator
or
gas
analyzer
functioning
within
an
anesthesia
workstation,
or
pluggable
modules
in
a
patient
monitor
controlling
invasive
blood
pressure
or
gathering
EEG
data.
Device
vs
deviceDefinition:
The
Information
systems
using
such
data
need
to
be
able
to
understand
the
structure
and
dynamic
state
of
the
devices
originating
them.
This
requires
more
than
a
single
Device
resource
-
a
hierarchy
of
Device
resources
is
meant
constructed
carrying
data
about
the
top-level
containing
device
(for
example
a
monitor),
and
a
hierarchy
of
contained
Device
resources
representing
subsystems
(in
the
monitor,
builtin
and
attached
modular
measurement
capabilities),
channels,
and
DeviceMetric
resources
representing
individual
measurements
or
computations.
A
device
that
is
intended
to
refer
be
used
on
one
individual
during
a
single
procedure;
MDR
(EU)
2017/745
Accessed
12
May
2022
Reusable
medical
devices
are
devices
that
health
care
providers
can
reuse
to
diagnose
and
treat
one
or
multiple
patients.
Examples
of
reusable
medical
devices
include
surgical
forceps,
endoscopes
and
laryngoscopes.
US
Food
and
Drug
Administration
Center
for
Devices
and
Radiological
Health
Reusable
Medical
Devices
A
Device
may
be
a
software
component
or
application.
A
software
item
like
a
data
transformer
or
converter,
or
a
clinical
support
algorithm,
may
be
an
independently
deployed,
managed
and
configured
entity
that
contributes
to
patient
care
and
needs
to
be
documented
just
a
surely
as,
say,
a
physical
instance
cardiac
monitor.
It
can
also
represent
the
relationship
of
the
software
item
to
other
device
and
information
system
components
through
reference
linkages.
This
category
includes
software
regardless
of
whether
or
not
is
regulated.
Device
instances
documenting
software
items
are
important
to
traceability
of
data
and
analyzing
adverse
events,
and
so
have
important
patient
safety
roles.
These
may
also
be
considered
Digital
therapeutics
(DTx)
in
some
contexts.
Software
as
a
medical
device
-
hence
having
attributes
like
lot
number,
patient,
location,
operational
status
which
the
DeviceDefinition
resource
does
may
include
not
have.
only
traditional
applications
but
also
standalone
algorithms,
rule
engines,
artificial
intelligence
(AI),
machine
learning
(ML)
components,
and
decision-support
modules.
These
software-based
devices
may
operate
independently
or
be
embedded
within
physical
hardware
to
be
used
in
clinical
and
non-clinical
contexts.
There are a number of resources that either represent other aspects of a device and/or reference a DeviceDefinition:
DeviceDefinition: this resource.
Device: Represents an actual instance of the device, references the DeviceDefinition for further description and characteristics of the device that do not change across the same “kind” of device. For example, the physical characteristic would not change, while the actual configuration used is within the valid configurations that may be documented in the DeviceDefinition.
Where
the
DeviceDefinition
is
referenced
by
other
resources
listed
in
References
to
this
Resource,
beyond
Device,
the
DeviceDefinition
is
a
choice
between
DeviceDefinition
and
a
Device
depending
on
whether
a
specific
device
is
to
be
considered
or
a
kind
of
device.
For
example
one
may
indicate
a
specific
device
as
part
of
a
ServiceRequest
order
detail
or
a
kind
of
device
using
DeviceDefinition;
one
may
indicate
a
specific
device
to
always
perform
the
observation
or
a
kind
of
device
as
part
of
an
ObservationDefinition;
one
may
document
a
specific
device
or
kind
of
device
used
to
collect
a
Specimen.
Note that in some jurisdictions a regulated product might not be considered a device, but may be regulated as a medication or a biologic. These boundaries are not controlled for in the FHIR Resources, but should be considered when working in the healthcare product space, specifically:
Structure
| Name | Flags | Card. | Type |
Description
&
Constraints
Filter:
|
||||
|---|---|---|---|---|---|---|---|---|
DeviceDefinition
|
|
DomainResource |
The
definition
of
a
Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension Interfaces Implemented: CanonicalResource |
|||||
|
Σ C | 0..1 |
uri
|
Canonical
identifier
for
this
DeviceDefinition,
represented
as
an
absolute
URI
(globally
unique)
+ Warning: URL should not contain | or # - these characters make processing canonical references problematic | ||||
identifier
|
Σ | 0..* | Identifier |
Additional
| ||||
|
version
| Σ | 0..1 | string |
Business
version
of
the
DeviceDefinition
| ||||
 
versionAlgorithm[x]
| Σ | 0..1 |
How
to
Binding: Version Algorithm ( Extensible ) | |||||
versionAlgorithmString
| string | |||||||
versionAlgorithmCoding
| Coding | |||||||
|
name
| Σ | 0..1 | string |
Name
for
this
DeviceDefinition
(computer
friendly)
| ||||
|
title
| Σ | 0..1 | string |
Name
for
this
DeviceDefinition
(human
friendly)
| ||||
|
status
| ?! Σ | 1..1 | code |
draft
|
active
|
retired
|
unknown
Binding: PublicationStatus ( Required ) | ||||
|
experimental
| Σ | 0..1 | boolean |
For
testing
only
-
never
for
real
usage
| ||||
|
partNumber
| 0..1 | string |
The
part
number
or
catalog
number
of
the
device
|
|||||
manufacturer
|
Σ | 0..1 | Reference ( Organization ) |
Name
of
device
manufacturer
| ||||
|
modelNumber
| Σ | 0..1 | string |
The
catalog
or
model
number
for
the
device
for
example
as
defined
by
the
manufacturer
| ||||
|
date
| Σ | 0..1 | dateTime |
Date
last
changed
| ||||
|
contact
| Σ | 0..* |
ContactDetail
|
Contact
details
for
the
publisher
| ||||
|
publisher
|
| 0..1 | string |
The
name
of
the
organization
responsible
for
publishing
the
definition
| ||||
|
useContext
| Σ | 0..* | UsageContext |
The
context
that
the
content
is
intended
to
support
|
||||
|
jurisdiction
| Σ | 0..* | CodeableConcept |
Jurisdiction
of
the
authority
that
maintains
the
DeviceDefinition
(if
applicable)
Binding: Jurisdiction ValueSet
(
Extensible
)
| ||||
|
purpose
| 0..1 | markdown |
Why
this
DeviceDefinition
is
defined
| |||||
|
copyright
| 0..1 | markdown |
Notice
about
intellectual
property
ownership,
can
include
restrictions
on
use
| |||||
|
copyrightLabel
| T | 0..1 | string |
Copyright
holder
and
year(s)
| ||||
udiDeviceIdentifier
|
0..* | BackboneElement |
Unique
Device
Identifier
(UDI)
Barcode
string
|
|||||
|
deviceIdentifier
|
1..1 | string |
The
identifier
that
is
to
be
associated
with
every
Device
that
references
this
DeviceDefintiion
for
the
issuer
and
jurisdiction
provided
in
the
DeviceDefinition.udiDeviceIdentifier
|
|||||
|
issuer
|
1..1 | uri |
The
organization
that
assigns
the
identifier
algorithm
|
|||||
|
jurisdiction
|
1..1 | uri |
The
jurisdiction
to
which
the
deviceIdentifier
applies
|
|||||
|
marketDistribution
|
0..* | BackboneElement |
Indicates
whether
and
when
the
device
is
available
on
the
market
|
|||||
|
marketPeriod
|
1..1 | Period |
Begin
and
end
dates
for
the
commercial
distribution
of
the
device
|
|||||
|
subJurisdiction
|
1..1 | uri |
National
state
or
territory
where
the
device
is
commercialized
|
|||||
|
deviceIdentifierSystem
| 0..1 | uri |
The
namespace
for
the
device
identifier
value
| |||||
|
regulatoryIdentifier
|
0..* | BackboneElement |
Regulatory
identifier(s)
associated
with
this
device
|
|||||
|
type
|
1..1 | code |
basic
|
master
|
license
Binding: Device Definition Regulatory Identifier Type ( Required ) |
|||||
|
|
1..1 | string |
The
identifier
itself
|
|||||
|
issuer
|
1..1 | uri |
The
organization
that
issued
this
identifier
|
|||||
|
jurisdiction
|
1..1 | uri |
Relevant
jurisdiction
|
|||||
|
|
0..1 |
|
The
|
|||||
|
deviceName
|
Σ | 0..* | BackboneElement |
The
name
or
names
of
the
device
as
given
by
the
manufacturer
|
||||
|
name
|
Σ | 1..1 | string |
A
name
that
is
used
to
refer
to
the
device
|
||||
|
type
|
Σ | 1..1 |
|
registered-name
|
user-friendly-name
|
patient-reported-name
Binding: Device Name Type ( |
||||
|
classification
|
Σ | 0..* | BackboneElement |
What
kind
of
device
or
device
system
this
is
|
||||
|
type
|
Σ | 1..1 | CodeableConcept |
A
classification
or
risk
class
of
the
device
model
Binding: Device Type ( Example ) |
||||
|
justification
|
0..* | RelatedArtifact |
Further
information
qualifying
this
classification
of
the
device
model
|
|||||
|
conformsTo
|
Σ | 0..* | BackboneElement |
Identifies
the
standards,
specifications,
or
formal
guidances
for
the
capabilities
supported
by
the
device
|
||||
|
category
|
Σ | 0..1 | CodeableConcept |
Describes
the
common
type
of
the
standard,
specification,
or
formal
guidance
Binding: Device Specification Category ( Example ) |
||||
|
specification
|
Σ | 1..1 | CodeableConcept |
Identifies
the
standard,
specification,
or
formal
guidance
that
the
device
adheres
to
the
Device
Specification
type
Binding: Device Specification Type ( Example ) |
||||
|
version
|
Σ | 0..* | string |
The
specific
form
or
variant
of
the
standard,
specification
or
formal
guidance
|
||||
|
source
|
0..* | RelatedArtifact |
Standard,
regulation,
certification,
or
guidance
website,
document,
or
other
publication,
or
similar,
supporting
the
conformance
|
|||||
|
hasPart
|
Σ | 0..* | BackboneElement |
A
device,
part
of
the
current
one
|
||||
|
definition[x]
|
Σ | 1..1 |
Reference
to
the
part
Binding: Device Type ( Example ) | |||||
|
definitionCanonical
| canonical ( DeviceDefinition ) |
|
||||||
|
definitionCodeableConcept
| CodeableConcept | |||||||
|
count
|
0..1 | integer |
Number
of
occurrences
of
the
part
|
|||||
|
packaging
|
0..* | BackboneElement |
Information
about
the
packaging
of
the
device,
i.e.
how
the
device
is
packaged
|
|||||
|
identifier
|
0..1 | Identifier |
Business
identifier
of
the
packaged
medication
|
|||||
|
type
|
0..1 | CodeableConcept |
A
code
that
defines
the
specific
type
of
packaging
|
|||||
|
count
|
0..1 | integer |
The
number
of
items
contained
in
the
package
(devices
or
sub-packages)
|
|||||
|
distributor
|
0..* | BackboneElement |
An
organization
that
distributes
the
packaged
device
|
|||||
|
name
|
0..1 | string |
Distributor's
human-readable
name
|
|||||
|
organizationReference
|
0..* | Reference ( Organization ) |
Distributor
as
an
Organization
resource
|
|||||
udiDeviceIdentifier
|
0..* | see udiDeviceIdentifier |
Unique
Device
Identifier
(UDI)
Barcode
string
on
the
packaging
|
|||||
|
packaging
|
0..* | see packaging |
Allows
packages
within
packages
|
|||||
|
|
0..* | BackboneElement |
The
version
of
the
device
or
software
|
|||||
|
type
|
0..1 | CodeableConcept |
The
type
of
the
device
version,
e.g.
manufacturer,
approved,
internal
|
|||||
|
component
|
0..1 | Identifier |
The
hardware
or
software
module
of
the
device
to
which
the
version
applies
|
|||||
|
value
|
1..1 | string |
The
version
text
|
|||||
|
safety
|
Σ | 0..* | CodeableConcept |
Safety
characteristics
of
the
device
Binding: Device Safety ( Example ) |
||||
|
shelfLifeStorage
|
0..* | ProductShelfLife |
Shelf
Life
and
storage
information
|
|||||
|
outputLanguage
|
0..* |
|
Language
code
for
the
human-readable
text
strings
produced
by
the
device
(all
supported)
Binding: All Languages ( Required )
|
|||||
|
property
|
0..* | BackboneElement |
Inherent,
essentially
fixed,
characteristics
of
this
kind
of
device,
e.g.,
time
properties,
size,
etc
|
|||||
|
type
|
1..1 | CodeableConcept |
Code
that
specifies
the
property
being
represented
Binding: Device Property Type (Example only) ( Example ) |
|||||
value[x]
|
1..1 |
Value
of
the
property
|
||||||
valueQuantity
|
Quantity | |||||||
|
valueCodeableConcept
|
CodeableConcept | |||||||
|
valueString
|
string | |||||||
|
valueBoolean
|
boolean | |||||||
|
valueInteger
|
integer | |||||||
|
valueRange
|
Range | |||||||
|
valueAttachment
|
Attachment | |||||||
|
link
|
0..* | BackboneElement |
An
associated
device,
attached
to,
used
with,
communicating
with
or
linking
a
previous
or
new
device
model
to
the
focal
device
|
|||||
|
relation
|
1..1 | Coding |
The
type
indicates
the
relationship
of
the
related
device
to
the
device
instance
Binding: Device Definition Relation Type ( Extensible ) |
|||||
|
relatedDevice[x]
|
1..1 |
A
reference
to
the
linked
device
Binding: Device Type ( Example ) |
||||||
|
relatedDeviceCanonical
| canonical ( DeviceDefinition ) |
|
||||||
|
relatedDeviceCodeableConcept
| CodeableConcept | |||||||
|
note
|
0..* | Annotation |
Device
notes
and
comments
|
|||||
|
material
|
0..* | BackboneElement |
A
substance
used
to
create
the
material(s)
of
which
the
device
is
made
|
|||||
|
substance
|
1..1 | CodeableConcept |
A
relevant
substance
that
the
device
contains,
may
contain,
or
is
made
of
Binding: Substance Code ( Example ) |
|||||
|
alternate
|
0..1 | boolean |
Indicates
an
alternative
material
of
the
device
|
|||||
|
allergenicIndicator
|
0..1 | boolean |
Whether
the
substance
is
a
known
or
suspected
allergen
|
|||||
|
productionIdentifierInUDI
|
0..* |
|
lot-number
|
manufactured-date
|
serial-number
|
expiration-date
|
biological-source
|
software-version
Binding: Device Production Identifier In UDI ( |
|||||
|
guideline
|
0..1 | BackboneElement |
Information
aimed
at
providing
directions
for
the
usage
of
this
model
of
device
|
|||||
|
useContext
|
0..* | UsageContext |
The
circumstances
that
form
the
setting
for
using
the
device
|
|||||
|
usageInstruction
|
0..1 | markdown |
Detailed
written
and
visual
directions
for
the
user
on
how
to
use
the
device
|
|||||
|
relatedArtifact
|
0..* | RelatedArtifact |
A
source
of
information
or
reference
for
this
guideline
|
|||||
|
indication
|
0..* | CodeableConcept |
A
clinical
condition
for
which
the
device
was
designed
to
be
used
|
|||||
|
contraindication
|
0..* | CodeableConcept |
A
specific
situation
when
a
device
should
not
be
used
because
it
may
cause
harm
|
|||||
|
warning
|
0..* | CodeableConcept |
Specific
hazard
alert
information
that
a
user
needs
to
know
before
using
the
device
|
|||||
|
intendedUse
|
0..1 | string |
A
description
of
the
general
purpose
or
medical
use
of
the
device
or
its
function
|
|||||
|
correctiveAction
|
0..1 | BackboneElement |
Tracking
of
latest
field
safety
corrective
action
|
|||||
|
recall
|
1..1 | boolean |
Whether
the
corrective
action
was
a
recall
|
|||||
|
scope
|
0..1 | code |
model
|
lot-numbers
|
serial-numbers
Binding: Device Corrective Action Scope ( Required ) |
|||||
|
period
|
1..1 | Period |
Start
and
end
dates
of
the
corrective
action
|
|||||
|
chargeItem
|
0..* | BackboneElement |
Billing
code
or
reference
associated
with
the
device
|
|||||
|
chargeItemCode
|
1..1 |
CodeableReference
|
The
code
or
reference
for
the
charge
item
Binding: USCLS Codes ( Example ) |
|||||
|
count
|
1..1 | Quantity |
Coefficient
applicable
to
the
billing
code
|
|||||
|
effectivePeriod
|
0..1 | Period |
A
specific
time
period
in
which
this
charge
item
applies
|
|||||
|
useContext
|
0..* | UsageContext |
The
context
to
which
this
charge
item
applies
|
|||||
|
Documentation
for
this
format
|
||||||||
See the Extensions for this resource
UML Diagram ( Legend )
XML Template
<<DeviceDefinition xmlns="http://hl7.org/fhir"><!-- from Resource: id, meta, implicitRules, and language --> <!-- from DomainResource: text, contained, extension, and modifierExtension -->
< <</identifier> <<url value="[uri]"/><!-- 0..1 Canonical identifier for this DeviceDefinition, represented as an absolute URI (globally unique) --> <identifier><!-- 0..* Identifier Additional identifier for the DeviceDefinition --></identifier> <version value="[string]"/><!-- 0..1 Business version of the DeviceDefinition --> <versionAlgorithm[x]><!-- 0..1 string|Coding How to compare versions --></versionAlgorithm[x]> <name value="[string]"/><!-- 0..1 Name for this DeviceDefinition (computer friendly) --> <title value="[string]"/><!-- 0..1 Name for this DeviceDefinition (human friendly) --> <status value="[code]"/><!-- 1..1 draft | active | retired | unknown --> <experimental value="[boolean]"/><!-- 0..1 For testing only - never for real usage --> <partNumber value="[string]"/><!-- 0..1 The part number or catalog number of the device --> <manufacturer><!-- 0..1 Reference(Organization) Name of device manufacturer --></manufacturer> <modelNumber value="[string]"/><!-- 0..1 The catalog or model number for the device for example as defined by the manufacturer --> <date value="[dateTime]"/><!-- 0..1 Date last changed --> <contact><!-- 0..* ContactDetail Contact details for the publisher --></contact> <publisher value="[string]"/><!-- 0..1 The name of the organization responsible for publishing the definition --> <useContext><!-- 0..* UsageContext The context that the content is intended to support --></useContext> <jurisdiction><!-- 0..* CodeableConcept Jurisdiction of the authority that maintains the DeviceDefinition (if applicable)<<identifier value="[string]"/><!-- 1..1 The identifier itself --> <issuer value="[uri]"/><!-- 1..1 The organization that issued this identifier --><<jurisdiction value="[uri]"/><!-- 1..1 Relevant jurisdiction governing the identifier --> <identifierSystem value="[uri]"/><!-- 0..1 The namespace for the device identifier value --> </regulatoryIdentifier>< <</manufacturer><deviceName> <!-- 0..* The name or names of the device as given by the manufacturer --> <name value="[string]"/><!-- 1..1 A name that is used to refer to the device --><<a href="devicedefinition-definitions.html#DeviceDefinition.deviceName.type" title="The type of deviceName. RegisteredName | UserFriendlyName | PatientReportedName." class="dict"><type><!-- 1..1 CodeableConcept registered-name | user-friendly-name | patient-reported-name --></type> </deviceName><<classification> <!-- 0..* What kind of device or device system this is --> <type><!-- 1..1 CodeableConcept A classification or risk class of the device model --></type> <justification><!-- 0..* RelatedArtifact Further information qualifying this classification of the device model --></justification> </classification> <conformsTo> <!-- 0..* Identifies the standards, specifications, or formal guidances for the capabilities supported by the device --> <category><!-- 0..1 CodeableConcept Describes the common type of the standard, specification, or formal guidance --></category> <specification><!-- 1..1 CodeableConcept Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type --></specification> <version value="[string]"/><!-- 0..* The specific form or variant of the standard, specification or formal guidance --> <source><!-- 0..* RelatedArtifact Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance --></source> </conformsTo> <hasPart> <!-- 0..* A device, part of the current one --><</reference><definition[x]><!-- 1..1 canonical(DeviceDefinition)|CodeableConcept Reference to the part --></definition[x]> <count value="[integer]"/><!-- 0..1 Number of occurrences of the part --> </hasPart> <packaging> <!-- 0..* Information about the packaging of the device, i.e. how the device is packaged --> <identifier><!-- 0..1 Identifier Business identifier of the packaged medication --></identifier> <type><!-- 0..1 CodeableConcept A code that defines the specific type of packaging --></type> <count value="[integer]"/><!-- 0..1 The number of items contained in the package (devices or sub-packages) --> <distributor> <!-- 0..* An organization that distributes the packaged device --> <name value="[string]"/><!-- 0..1 Distributor's human-readable name --> <organizationReference><!-- 0..* Reference(Organization) Distributor as an Organization resource --></organizationReference> </distributor> <udiDeviceIdentifier><!-- 0..* Content as for DeviceDefinition.udiDeviceIdentifier Unique Device Identifier (UDI) Barcode string on the packaging --></udiDeviceIdentifier> <packaging><!-- 0..* Content as for DeviceDefinition.packaging Allows packages within packages --></packaging> </packaging>< <</type> <</component> < </version><deviceVersion> <!-- 0..* The version of the device or software --> <type><!-- 0..1 CodeableConcept The type of the device version, e.g. manufacturer, approved, internal --></type> <component><!-- 0..1 Identifier The hardware or software module of the device to which the version applies --></component> <value value="[string]"/><!-- 1..1 The version text --> </deviceVersion> <safety><!-- 0..* CodeableConcept Safety characteristics of the device --></safety> <shelfLifeStorage><!-- 0..* ProductShelfLife Shelf Life and storage information --></shelfLifeStorage><</languageCode><outputLanguage value="[code]"/><!-- 0..* Language code for the human-readable text strings produced by the device (all supported) --> <property> <!-- 0..* Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc --> <type><!-- 1..1 CodeableConcept Code that specifies the property being represented --></type> <value[x]><!-- 1..1 Quantity|CodeableConcept|string|boolean|integer|Range| Attachment Value of the property --></value[x]> </property><</owner> <</contact><link> <!-- 0..* An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device --> <relation><!-- 1..1 Coding The type indicates the relationship of the related device to the device instance --></relation><</relatedDevice><relatedDevice[x]><!-- 1..1 canonical(DeviceDefinition)|CodeableConcept A reference to the linked device --></relatedDevice[x]> </link> <note><!-- 0..* Annotation Device notes and comments --></note> <material> <!-- 0..* A substance used to create the material(s) of which the device is made --><</substance><substance><!-- 1..1 CodeableConcept A relevant substance that the device contains, may contain, or is made of --></substance> <alternate value="[boolean]"/><!-- 0..1 Indicates an alternative material of the device --> <allergenicIndicator value="[boolean]"/><!-- 0..1 Whether the substance is a known or suspected allergen --> </material><<productionIdentifierInUDI><!-- 0..* CodeableConcept lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version --></productionIdentifierInUDI> <guideline> <!-- 0..1 Information aimed at providing directions for the usage of this model of device --> <useContext><!-- 0..* UsageContext The circumstances that form the setting for using the device --></useContext> <usageInstruction value="[markdown]"/><!-- 0..1 Detailed written and visual directions for the user on how to use the device --> <relatedArtifact><!-- 0..* RelatedArtifact A source of information or reference for this guideline --></relatedArtifact> <indication><!-- 0..* CodeableConcept A clinical condition for which the device was designed to be used --></indication> <contraindication><!-- 0..* CodeableConcept A specific situation when a device should not be used because it may cause harm --></contraindication> <warning><!-- 0..* CodeableConcept Specific hazard alert information that a user needs to know before using the device --></warning> <intendedUse value="[string]"/><!-- 0..1 A description of the general purpose or medical use of the device or its function --> </guideline> <correctiveAction> <!-- 0..1 Tracking of latest field safety corrective action --> <recall value="[boolean]"/><!-- 1..1 Whether the corrective action was a recall --> <scope value="[code]"/><!-- 0..1 model | lot-numbers | serial-numbers --> <period><!-- 1..1 Period Start and end dates of the corrective action --></period> </correctiveAction> <chargeItem> <!-- 0..* Billing code or reference associated with the device --><</chargeItemCode><chargeItemCode><!-- 1..1 CodeableReference The code or reference for the charge item --></chargeItemCode> <count><!-- 1..1 Quantity Coefficient applicable to the billing code --></count> <effectivePeriod><!-- 0..1 Period A specific time period in which this charge item applies --></effectivePeriod> <useContext><!-- 0..* UsageContext The context to which this charge item applies --></useContext> </chargeItem> </DeviceDefinition>
JSON Template
{
"resourceType" : "",
"resourceType" : "DeviceDefinition",
// from Resource: id, meta, implicitRules, and language
// from DomainResource: text, contained, extension, and modifierExtension
"
"
"
"url" : "<uri>", // Canonical identifier for this DeviceDefinition, represented as an absolute URI (globally unique)
"identifier" : [{ Identifier }], // Additional identifier for the DeviceDefinition
"version" : "<string>", // Business version of the DeviceDefinition
// versionAlgorithm[x]: How to compare versions. One of these 2:
"versionAlgorithmString" : "<string>",
"versionAlgorithmCoding" : { Coding },
"name" : "<string>", // Name for this DeviceDefinition (computer friendly)
"title" : "<string>", // Name for this DeviceDefinition (human friendly)
"status" : "<code>", // R! draft | active | retired | unknown
"experimental" : <boolean>, // For testing only - never for real usage
"partNumber" : "<string>", // The part number or catalog number of the device
"manufacturer" : { Reference(Organization) }, // Name of device manufacturer
"modelNumber" : "<string>", // The catalog or model number for the device for example as defined by the manufacturer
"date" : "<dateTime>", // Date last changed
"contact" : [{ ContactDetail }], // Contact details for the publisher
"publisher" : "<string>", // The name of the organization responsible for publishing the definition
"useContext" : [{ UsageContext }], // The context that the content is intended to support
"jurisdiction" : [{ CodeableConcept }], // Jurisdiction of the authority that maintains the DeviceDefinition (if applicable)
"purpose" : "<markdown>", // Why this DeviceDefinition is defined
"copyright" : "<markdown>", // Notice about intellectual property ownership, can include restrictions on use
"copyrightLabel" : "<string>", // Copyright holder and year(s)
"udiDeviceIdentifier" : [{ // Unique Device Identifier (UDI) Barcode string
"deviceIdentifier" : "<string>", // R! The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier
"issuer" : "<uri>", // R! The organization that assigns the identifier algorithm
"jurisdiction" : "<uri>", // R! The jurisdiction to which the deviceIdentifier applies
"marketDistribution" : [{ // Indicates whether and when the device is available on the market
"marketPeriod" : { Period }, // R! Begin and end dates for the commercial distribution of the device
"subJurisdiction" : "<uri>" // R! National state or territory where the device is commercialized
}]
}],
"deviceIdentifierSystem" : "<uri>" // The namespace for the device identifier value
}],
"regulatoryIdentifier" : [{ // Regulatory identifier(s) associated with this device
"type" : "<code>", // R! basic | master | license
"
"identifier" : "<string>", // R! The identifier itself
"issuer" : "<uri>", // R! The organization that issued this identifier
"
"jurisdiction" : "<uri>", // R! Relevant jurisdiction governing the identifier
"identifierSystem" : "<uri>" // The namespace for the device identifier value
}],
"
"
"deviceName" : [{ // The name or names of the device as given by the manufacturer
"name" : "<string>", // R! A name that is used to refer to the device
"<a href="devicedefinition-definitions.html#DeviceDefinition.deviceName.type" title="The type of deviceName.
RegisteredName | UserFriendlyName | PatientReportedName." class="dict">type
"type" : { CodeableConcept } // R! registered-name | user-friendly-name | patient-reported-name
}],
"
"classification" : [{ // What kind of device or device system this is
"type" : { CodeableConcept }, // R! A classification or risk class of the device model
"justification" : [{ RelatedArtifact }] // Further information qualifying this classification of the device model
}],
"conformsTo" : [{ // Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
"category" : { CodeableConcept }, // Describes the common type of the standard, specification, or formal guidance
"specification" : { CodeableConcept }, // R! Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
"version" : ["<string>"], // The specific form or variant of the standard, specification or formal guidance
"source" : [{ RelatedArtifact }] // Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance
}],
"hasPart" : [{ // A device, part of the current one
"
// definition[x]: Reference to the part. One of these 2:
"definitionCanonical" : "<canonical(DeviceDefinition)>",
"definitionCodeableConcept" : { CodeableConcept },
"count" : <integer> // Number of occurrences of the part
}],
"packaging" : [{ // Information about the packaging of the device, i.e. how the device is packaged
"identifier" : { Identifier }, // Business identifier of the packaged medication
"type" : { CodeableConcept }, // A code that defines the specific type of packaging
"count" : <integer>, // The number of items contained in the package (devices or sub-packages)
"distributor" : [{ // An organization that distributes the packaged device
"name" : "<string>", // Distributor's human-readable name
"organizationReference" : [{ Reference(Organization) }] // Distributor as an Organization resource
}],
"udiDeviceIdentifier" : [{ Content as for DeviceDefinition.udiDeviceIdentifier }], // Unique Device Identifier (UDI) Barcode string on the packaging
"packaging" : [{ Content as for DeviceDefinition.packaging }] // Allows packages within packages
}],
"
"
"
"
"deviceVersion" : [{ // The version of the device or software
"type" : { CodeableConcept }, // The type of the device version, e.g. manufacturer, approved, internal
"component" : { Identifier }, // The hardware or software module of the device to which the version applies
"value" : "<string>" // R! The version text
}],
"safety" : [{ CodeableConcept }], // Safety characteristics of the device
"shelfLifeStorage" : [{ ProductShelfLife }], // Shelf Life and storage information
"
"outputLanguage" : ["<code>"], // Language code for the human-readable text strings produced by the device (all supported)
"property" : [{ // Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
"type" : { CodeableConcept }, // R! Code that specifies the property being represented
// value[x]: Value of the property. One of these 7:
"valueQuantity" : { Quantity },
"valueCodeableConcept" : { CodeableConcept },
"valueString" : "<string>",
"valueBoolean" : <boolean>,
"valueInteger" : <integer>,
"valueRange" : { Range },
"valueAttachment" : { Attachment }
}],
"
"
"link" : [{ // An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
"relation" : { Coding }, // R! The type indicates the relationship of the related device to the device instance
"
// relatedDevice[x]: A reference to the linked device. One of these 2:
"relatedDeviceCanonical" : "<canonical(DeviceDefinition)>",
"relatedDeviceCodeableConcept" : { CodeableConcept }
}],
"note" : [{ Annotation }], // Device notes and comments
"material" : [{ // A substance used to create the material(s) of which the device is made
"
"substance" : { CodeableConcept }, // R! A relevant substance that the device contains, may contain, or is made of
"alternate" : <boolean>, // Indicates an alternative material of the device
"allergenicIndicator" : <boolean> // Whether the substance is a known or suspected allergen
}],
"
"productionIdentifierInUDI" : [{ CodeableConcept }], // lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
"guideline" : { // Information aimed at providing directions for the usage of this model of device
"useContext" : [{ UsageContext }], // The circumstances that form the setting for using the device
"usageInstruction" : "<markdown>", // Detailed written and visual directions for the user on how to use the device
"relatedArtifact" : [{ RelatedArtifact }], // A source of information or reference for this guideline
"indication" : [{ CodeableConcept }], // A clinical condition for which the device was designed to be used
"contraindication" : [{ CodeableConcept }], // A specific situation when a device should not be used because it may cause harm
"warning" : [{ CodeableConcept }], // Specific hazard alert information that a user needs to know before using the device
"intendedUse" : "<string>" // A description of the general purpose or medical use of the device or its function
},
"correctiveAction" : { // Tracking of latest field safety corrective action
"recall" : <boolean>, // R! Whether the corrective action was a recall
"scope" : "<code>", // model | lot-numbers | serial-numbers
"period" : { Period } // R! Start and end dates of the corrective action
},
"chargeItem" : [{ // Billing code or reference associated with the device
"
"chargeItemCode" : { CodeableReference }, // R! The code or reference for the charge item
"count" : { Quantity }, // R! Coefficient applicable to the billing code
"effectivePeriod" : { Period }, // A specific time period in which this charge item applies
"useContext" : [{ UsageContext }] // The context to which this charge item applies
}]
}
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> .[ a fhir:;[ a fhir:DeviceDefinition; fhir:nodeRole fhir:treeRoot; # if this is the parser root# from # from fhir: fhir: fhir:# from Resource: fhir:id, fhir:meta, fhir:implicitRules, and fhir:language # from DomainResource: fhir:text, fhir:contained, fhir:extension, and fhir:modifierExtension fhir:url [ uri ] ; # 0..1 Canonical identifier for this DeviceDefinition, represented as an absolute URI (globally unique) fhir:identifier ( [ Identifier ] ... ) ; # 0..* Additional identifier for the DeviceDefinition fhir:version [ string ] ; # 0..1 Business version of the DeviceDefinition # versionAlgorithm[x] : 0..1 How to compare versions. One of these 2 fhir:versionAlgorithm [ a fhir:String ; string ] fhir:versionAlgorithm [ a fhir:Coding ; Coding ] fhir:name [ string ] ; # 0..1 Name for this DeviceDefinition (computer friendly) fhir:title [ string ] ; # 0..1 Name for this DeviceDefinition (human friendly) fhir:status [ code ] ; # 1..1 draft | active | retired | unknown fhir:experimental [ boolean ] ; # 0..1 For testing only - never for real usage fhir:partNumber [ string ] ; # 0..1 The part number or catalog number of the device fhir:manufacturer [ Reference(Organization) ] ; # 0..1 Name of device manufacturer fhir:modelNumber [ string ] ; # 0..1 The catalog or model number for the device for example as defined by the manufacturer fhir:date [ dateTime ] ; # 0..1 Date last changed fhir:contact ( [ ContactDetail ] ... ) ; # 0..* Contact details for the publisher fhir:publisher [ string ] ; # 0..1 The name of the organization responsible for publishing the definition fhir:useContext ( [ UsageContext ] ... ) ; # 0..* The context that the content is intended to support fhir:jurisdiction ( [ CodeableConcept ] ... ) ; # 0..* Jurisdiction of the authority that maintains the DeviceDefinition (if applicable) fhir:purpose [ markdown ] ; # 0..1 Why this DeviceDefinition is defined fhir:copyright [ markdown ] ; # 0..1 Notice about intellectual property ownership, can include restrictions on use fhir:copyrightLabel [ string ] ; # 0..1 Copyright holder and year(s) fhir:udiDeviceIdentifier ( [ # 0..* Unique Device Identifier (UDI) Barcode string fhir:deviceIdentifier [ string ] ; # 1..1 The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier fhir:issuer [ uri ] ; # 1..1 The organization that assigns the identifier algorithm fhir:jurisdiction [ uri ] ; # 1..1 The jurisdiction to which the deviceIdentifier applies fhir:marketDistribution ( [ # 0..* Indicates whether and when the device is available on the market fhir:marketPeriod [ Period ] ; # 1..1 Begin and end dates for the commercial distribution of the device fhir:subJurisdiction [ uri ] ; # 1..1 National state or territory where the device is commercialized ] ... ) ; fhir:deviceIdentifierSystem [ uri ] ; # 0..1 The namespace for the device identifier value ] ... ) ; fhir:regulatoryIdentifier ( [ # 0..* Regulatory identifier(s) associated with this device fhir:type [ code ] ; # 1..1 basic | master | licensefhir:fhir:identifier [ string ] ; # 1..1 The identifier itself fhir:issuer [ uri ] ; # 1..1 The organization that issued this identifierfhir:fhir:jurisdiction [ uri ] ; # 1..1 Relevant jurisdiction governing the identifier fhir:identifierSystem [ uri ] ; # 0..1 The namespace for the device identifier value ] ... ) ;fhir: fhir:fhir:deviceName ( [ # 0..* The name or names of the device as given by the manufacturer fhir:name [ string ] ; # 1..1 A name that is used to refer to the devicefhir:<a href="devicedefinition-definitions.html#DeviceDefinition.deviceName.type" title="The type of deviceName. RegisteredName | UserFriendlyName | PatientReportedName." class="dict">typefhir:type [ CodeableConcept ] ; # 1..1 registered-name | user-friendly-name | patient-reported-name ] ... ) ;fhir:fhir:classification ( [ # 0..* What kind of device or device system this is fhir:type [ CodeableConcept ] ; # 1..1 A classification or risk class of the device model fhir:justification ( [ RelatedArtifact ] ... ) ; # 0..* Further information qualifying this classification of the device model ] ... ) ; fhir:conformsTo ( [ # 0..* Identifies the standards, specifications, or formal guidances for the capabilities supported by the device fhir:category [ CodeableConcept ] ; # 0..1 Describes the common type of the standard, specification, or formal guidance fhir:specification [ CodeableConcept ] ; # 1..1 Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type fhir:version ( [ string ] ... ) ; # 0..* The specific form or variant of the standard, specification or formal guidance fhir:source ( [ RelatedArtifact ] ... ) ; # 0..* Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance ] ... ) ; fhir:hasPart ( [ # 0..* A device, part of the current onefhir:# definition[x] : 1..1 Reference to the part. One of these 2 fhir:definition [ a fhir:Canonical ; canonical(DeviceDefinition) ] fhir:definition [ a fhir:CodeableConcept ; CodeableConcept ] fhir:count [ integer ] ; # 0..1 Number of occurrences of the part ] ... ) ; fhir:packaging ( [ # 0..* Information about the packaging of the device, i.e. how the device is packaged fhir:identifier [ Identifier ] ; # 0..1 Business identifier of the packaged medication fhir:type [ CodeableConcept ] ; # 0..1 A code that defines the specific type of packaging fhir:count [ integer ] ; # 0..1 The number of items contained in the package (devices or sub-packages) fhir:distributor ( [ # 0..* An organization that distributes the packaged device fhir:name [ string ] ; # 0..1 Distributor's human-readable name fhir:organizationReference ( [ Reference(Organization) ] ... ) ; # 0..* Distributor as an Organization resource ] ... ) ; fhir:udiDeviceIdentifier ( [ See DeviceDefinition.udiDeviceIdentifier ] ... ) ; # 0..* Unique Device Identifier (UDI) Barcode string on the packaging fhir:packaging ( [ See DeviceDefinition.packaging ] ... ) ; # 0..* Allows packages within packages ] ... ) ;fhir: fhir: fhir: fhir:fhir:deviceVersion ( [ # 0..* The version of the device or software fhir:type [ CodeableConcept ] ; # 0..1 The type of the device version, e.g. manufacturer, approved, internal fhir:component [ Identifier ] ; # 0..1 The hardware or software module of the device to which the version applies fhir:value [ string ] ; # 1..1 The version text ] ... ) ; fhir:safety ( [ CodeableConcept ] ... ) ; # 0..* Safety characteristics of the device fhir:shelfLifeStorage ( [ ProductShelfLife ] ... ) ; # 0..* Shelf Life and storage informationfhir:fhir:outputLanguage ( [ code ] ... ) ; # 0..* Language code for the human-readable text strings produced by the device (all supported) fhir:property ( [ # 0..* Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc fhir:type [ CodeableConcept ] ; # 1..1 Code that specifies the property being represented # value[x] : 1..1 Value of the property. One of these 7 fhir:value [ a fhir:Quantity ; Quantity ] fhir:value [ a fhir:CodeableConcept ; CodeableConcept ]fhir: ] fhir: ] fhir: ]fhir:value [ a fhir:String ; string ] fhir:value [ a fhir:Boolean ; boolean ] fhir:value [ a fhir:Integer ; integer ] fhir:value [ a fhir:Range ; Range ] fhir:value [ a fhir:Attachment ; Attachment ] ] ... ) ;fhir: fhir:fhir:link ( [ # 0..* An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device fhir:relation [ Coding ] ; # 1..1 The type indicates the relationship of the related device to the device instancefhir:# relatedDevice[x] : 1..1 A reference to the linked device. One of these 2 fhir:relatedDevice [ a fhir:Canonical ; canonical(DeviceDefinition) ] fhir:relatedDevice [ a fhir:CodeableConcept ; CodeableConcept ] ] ... ) ; fhir:note ( [ Annotation ] ... ) ; # 0..* Device notes and comments fhir:material ( [ # 0..* A substance used to create the material(s) of which the device is made fhir:substance [ CodeableConcept ] ; # 1..1 A relevant substance that the device contains, may contain, or is made of fhir:alternate [ boolean ] ; # 0..1 Indicates an alternative material of the device fhir:allergenicIndicator [ boolean ] ; # 0..1 Whether the substance is a known or suspected allergen ] ... ) ;fhir:fhir:productionIdentifierInUDI ( [ CodeableConcept ] ... ) ; # 0..* lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version fhir:guideline [ # 0..1 Information aimed at providing directions for the usage of this model of device fhir:useContext ( [ UsageContext ] ... ) ; # 0..* The circumstances that form the setting for using the device fhir:usageInstruction [ markdown ] ; # 0..1 Detailed written and visual directions for the user on how to use the device fhir:relatedArtifact ( [ RelatedArtifact ] ... ) ; # 0..* A source of information or reference for this guideline fhir:indication ( [ CodeableConcept ] ... ) ; # 0..* A clinical condition for which the device was designed to be used fhir:contraindication ( [ CodeableConcept ] ... ) ; # 0..* A specific situation when a device should not be used because it may cause harm fhir:warning ( [ CodeableConcept ] ... ) ; # 0..* Specific hazard alert information that a user needs to know before using the device fhir:intendedUse [ string ] ; # 0..1 A description of the general purpose or medical use of the device or its function ] ; fhir:correctiveAction [ # 0..1 Tracking of latest field safety corrective action fhir:recall [ boolean ] ; # 1..1 Whether the corrective action was a recall fhir:scope [ code ] ; # 0..1 model | lot-numbers | serial-numbers fhir:period [ Period ] ; # 1..1 Start and end dates of the corrective action ] ; fhir:chargeItem ( [ # 0..* Billing code or reference associated with the devicefhir:fhir:chargeItemCode [ CodeableReference ] ; # 1..1 The code or reference for the charge item fhir:count [ Quantity ] ; # 1..1 Coefficient applicable to the billing code fhir:effectivePeriod [ Period ] ; # 0..1 A specific time period in which this charge item applies fhir:useContext ( [ UsageContext ] ... ) ; # 0..* The context to which this charge item applies ] ... ) ; ]
Changes from both R4 and R4B
| DeviceDefinition | |
| DeviceDefinition.version |
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| DeviceDefinition.status |
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| DeviceDefinition.experimental |
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| DeviceDefinition.manufacturer |
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| DeviceDefinition.date |
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| DeviceDefinition.contact |
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| DeviceDefinition.publisher |
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| DeviceDefinition.jurisdiction |
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| DeviceDefinition.purpose |
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| DeviceDefinition.copyrightLabel |
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| DeviceDefinition.udiDeviceIdentifier.marketDistribution |
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| DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod |
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| DeviceDefinition.udiDeviceIdentifier.deviceIdentifierSystem |
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| DeviceDefinition.regulatoryIdentifier.type |
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| DeviceDefinition.regulatoryIdentifier.identifierSystem |
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| DeviceDefinition.deviceName.type |
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| DeviceDefinition.classification |
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| DeviceDefinition.classification.type |
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| DeviceDefinition.classification.justification |
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| DeviceDefinition.conformsTo |
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| DeviceDefinition.conformsTo.category |
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| DeviceDefinition.conformsTo.specification |
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| DeviceDefinition.conformsTo.version |
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| DeviceDefinition.conformsTo.source |
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| DeviceDefinition.hasPart |
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| DeviceDefinition.hasPart.count |
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| DeviceDefinition.packaging |
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| DeviceDefinition.packaging.identifier |
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| DeviceDefinition.packaging.type |
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| DeviceDefinition.packaging.count |
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| DeviceDefinition.packaging.distributor |
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| DeviceDefinition.packaging.distributor.name |
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| DeviceDefinition.packaging.distributor.organizationReference |
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| DeviceDefinition.packaging.udiDeviceIdentifier |
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| DeviceDefinition.packaging.packaging |
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| DeviceDefinition.outputLanguage |
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| DeviceDefinition.property.value[x] |
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| DeviceDefinition.link |
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| DeviceDefinition.link.relation |
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| DeviceDefinition.productionIdentifierInUDI |
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| DeviceDefinition.guideline |
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| DeviceDefinition.guideline.useContext |
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| DeviceDefinition.guideline.usageInstruction |
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| DeviceDefinition.guideline.relatedArtifact |
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| DeviceDefinition.guideline.indication |
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| DeviceDefinition.guideline.contraindication |
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| DeviceDefinition.guideline.warning |
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| DeviceDefinition.guideline.intendedUse |
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| DeviceDefinition.correctiveAction |
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| DeviceDefinition.correctiveAction.recall |
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| DeviceDefinition.correctiveAction.scope |
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| DeviceDefinition.correctiveAction.period |
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| DeviceDefinition.chargeItem |
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| DeviceDefinition.chargeItem.chargeItemCode |
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| DeviceDefinition.chargeItem.count |
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| DeviceDefinition.chargeItem.effectivePeriod |
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| DeviceDefinition.chargeItem.useContext |
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| DeviceDefinition.specialization.systemType |
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| DeviceDefinition.physicalCharacteristics |
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| DeviceDefinition.languageCode |
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| DeviceDefinition.capability |
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| DeviceDefinition.property.valueQuantity |
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| DeviceDefinition.property.valueCode |
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| DeviceDefinition.quantity |
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| DeviceDefinition.parentDevice |
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See the Full Difference for further information
This analysis is available for R4 as XML or JSON and for R4B as XML or JSON .
Structure
| Name | Flags | Card. | Type |
Description
&
Constraints
Filter:
|
||||
|---|---|---|---|---|---|---|---|---|
|
DeviceDefinition
|
|
DomainResource |
The
definition
of
a
Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension Interfaces Implemented: CanonicalResource |
|||||
|
|
Σ C | 0..1 |
uri
|
Canonical
identifier
for
this
DeviceDefinition,
represented
as
an
absolute
URI
(globally
unique)
+ Warning: URL should not contain | or # - these characters make processing canonical references problematic | ||||
|
identifier
|
Σ | 0..* | Identifier |
Additional
| ||||
|
version
| Σ | 0..1 | string |
Business
version
of
the
DeviceDefinition
| ||||
|
versionAlgorithm[x]
| Σ | 0..1 |
How
to
Binding: Version Algorithm ( Extensible ) | |||||
|
versionAlgorithmString
| string | |||||||
|
versionAlgorithmCoding
| Coding | |||||||
|
name
| Σ | 0..1 | string |
Name
for
this
DeviceDefinition
(computer
friendly)
| ||||
|
title
| Σ | 0..1 | string |
Name
for
this
DeviceDefinition
(human
friendly)
| ||||
|
status
| ?! Σ | 1..1 | code |
draft
|
active
|
retired
|
unknown
Binding: PublicationStatus ( Required ) | ||||
|
experimental
| Σ | 0..1 | boolean |
For
testing
only
-
never
for
real
usage
| ||||
|
partNumber
| 0..1 | string |
The
part
number
or
catalog
number
of
the
device
|
|||||
|
manufacturer
|
Σ | 0..1 | Reference ( Organization ) |
Name
of
device
manufacturer
| ||||
|
modelNumber
| Σ | 0..1 | string |
The
catalog
or
model
number
for
the
device
for
example
as
defined
by
the
manufacturer
|
||||
|
date
| Σ | 0..1 | dateTime |
Date
last
changed
| ||||
|
contact
| Σ | 0..* |
ContactDetail
|
Contact
details
for
the
publisher
| ||||
|
publisher
|
| 0..1 | string |
The
name
of
the
organization
responsible
for
publishing
the
definition
| ||||
|
useContext
| Σ | 0..* | UsageContext |
The
context
that
the
content
is
intended
to
support
|
||||
|
jurisdiction
| Σ | 0..* | CodeableConcept |
Jurisdiction
of
the
authority
that
maintains
the
DeviceDefinition
(if
applicable)
Binding: Jurisdiction ValueSet
(
Extensible
)
| ||||
|
purpose
| 0..1 | markdown |
Why
this
DeviceDefinition
is
defined
| |||||
|
copyright
| 0..1 | markdown |
Notice
about
intellectual
property
ownership,
can
include
restrictions
on
use
| |||||
|
copyrightLabel
| T | 0..1 | string |
Copyright
holder
and
year(s)
| ||||
|
udiDeviceIdentifier
|
0..* | BackboneElement |
Unique
Device
Identifier
(UDI)
Barcode
string
|
|||||
|
deviceIdentifier
|
1..1 | string |
The
identifier
that
is
to
be
associated
with
every
Device
that
references
this
DeviceDefintiion
for
the
issuer
and
jurisdiction
provided
in
the
DeviceDefinition.udiDeviceIdentifier
|
|||||
|
issuer
|
1..1 | uri |
The
organization
that
assigns
the
identifier
algorithm
|
|||||
|
jurisdiction
|
1..1 | uri |
The
jurisdiction
to
which
the
deviceIdentifier
applies
|
|||||
|
marketDistribution
|
0..* | BackboneElement |
Indicates
whether
and
when
the
device
is
available
on
the
market
|
|||||
|
marketPeriod
|
1..1 | Period |
Begin
and
end
dates
for
the
commercial
distribution
of
the
device
|
|||||
|
subJurisdiction
|
1..1 | uri |
National
state
or
territory
where
the
device
is
commercialized
|
|||||
|
deviceIdentifierSystem
| 0..1 | uri |
The
namespace
for
the
device
identifier
value
| |||||
|
regulatoryIdentifier
|
0..* | BackboneElement |
Regulatory
identifier(s)
associated
with
this
device
|
|||||
|
type
|
1..1 | code |
basic
|
master
|
license
Binding: Device Definition Regulatory Identifier Type ( Required ) |
|||||
|
|
1..1 | string |
The
identifier
itself
|
|||||
|
issuer
|
1..1 | uri |
The
organization
that
issued
this
identifier
|
|||||
|
jurisdiction
|
1..1 | uri |
Relevant
jurisdiction
|
|||||
|
|
0..1 |
|
The
|
|||||
|
deviceName
|
Σ | 0..* | BackboneElement |
The
name
or
names
of
the
device
as
given
by
the
manufacturer
|
||||
|
name
|
Σ | 1..1 | string |
A
name
that
is
used
to
refer
to
the
device
|
||||
|
type
|
Σ | 1..1 |
|
registered-name
|
user-friendly-name
|
patient-reported-name
Binding: Device Name Type ( |
||||
|
classification
|
Σ | 0..* | BackboneElement |
What
kind
of
device
or
device
system
this
is
|
||||
|
type
|
Σ | 1..1 | CodeableConcept |
A
classification
or
risk
class
of
the
device
model
Binding: Device Type ( Example ) |
||||
|
justification
|
0..* | RelatedArtifact |
Further
information
qualifying
this
classification
of
the
device
model
|
|||||
|
conformsTo
|
Σ | 0..* | BackboneElement |
Identifies
the
standards,
specifications,
or
formal
guidances
for
the
capabilities
supported
by
the
device
|
||||
|
category
|
Σ | 0..1 | CodeableConcept |
Describes
the
common
type
of
the
standard,
specification,
or
formal
guidance
Binding: Device Specification Category ( Example ) |
||||
|
specification
|
Σ | 1..1 | CodeableConcept |
Identifies
the
standard,
specification,
or
formal
guidance
that
the
device
adheres
to
the
Device
Specification
type
Binding: Device Specification Type ( Example ) |
||||
|
version
|
Σ | 0..* | string |
The
specific
form
or
variant
of
the
standard,
specification
or
formal
guidance
|
||||
|
source
|
0..* | RelatedArtifact |
Standard,
regulation,
certification,
or
guidance
website,
document,
or
other
publication,
or
similar,
supporting
the
conformance
|
|||||
|
hasPart
|
Σ | 0..* | BackboneElement |
A
device,
part
of
the
current
one
|
||||
|
definition[x]
|
Σ | 1..1 |
Reference
to
the
part
Binding: Device Type ( Example ) | |||||
|
definitionCanonical
| canonical ( DeviceDefinition ) |
|
||||||
|
definitionCodeableConcept
| CodeableConcept | |||||||
|
count
|
0..1 | integer |
Number
of
occurrences
of
the
part
|
|||||
|
packaging
|
0..* | BackboneElement |
Information
about
the
packaging
of
the
device,
i.e.
how
the
device
is
packaged
|
|||||
|
identifier
|
0..1 | Identifier |
Business
identifier
of
the
packaged
medication
|
|||||
|
type
|
0..1 | CodeableConcept |
A
code
that
defines
the
specific
type
of
packaging
|
|||||
|
count
|
0..1 | integer |
The
number
of
items
contained
in
the
package
(devices
or
sub-packages)
|
|||||
|
distributor
|
0..* | BackboneElement |
An
organization
that
distributes
the
packaged
device
|
|||||
|
name
|
0..1 | string |
Distributor's
human-readable
name
|
|||||
|
organizationReference
|
0..* | Reference ( Organization ) |
Distributor
as
an
Organization
resource
|
|||||
|
udiDeviceIdentifier
|
0..* | see udiDeviceIdentifier |
Unique
Device
Identifier
(UDI)
Barcode
string
on
the
packaging
|
|||||
|
packaging
|
0..* | see packaging |
Allows
packages
within
packages
|
|||||
|
|
0..* | BackboneElement |
The
version
of
the
device
or
software
|
|||||
|
type
|
0..1 | CodeableConcept |
The
type
of
the
device
version,
e.g.
manufacturer,
approved,
internal
|
|||||
|
component
|
0..1 | Identifier |
The
hardware
or
software
module
of
the
device
to
which
the
version
applies
|
|||||
|
value
|
1..1 | string |
The
version
text
|
|||||
|
safety
|
Σ | 0..* | CodeableConcept |
Safety
characteristics
of
the
device
Binding: Device Safety ( Example ) |
||||
|
shelfLifeStorage
|
0..* | ProductShelfLife |
Shelf
Life
and
storage
information
|
|||||
|
outputLanguage
|
0..* |
|
Language
code
for
the
human-readable
text
strings
produced
by
the
device
(all
supported)
Binding: All Languages ( Required )
|
|||||
|
property
|
0..* | BackboneElement |
Inherent,
essentially
fixed,
characteristics
of
this
kind
of
device,
e.g.,
time
properties,
size,
etc
|
|||||
|
type
|
1..1 | CodeableConcept |
Code
that
specifies
the
property
being
represented
Binding: Device Property Type (Example only) ( Example ) |
|||||
|
value[x]
|
1..1 |
Value
of
the
property
|
||||||
|
valueQuantity
|
Quantity | |||||||
|
valueCodeableConcept
|
CodeableConcept | |||||||
|
valueString
|
string | |||||||
|
valueBoolean
|
boolean | |||||||
|
valueInteger
|
integer | |||||||
|
valueRange
|
Range | |||||||
|
valueAttachment
|
Attachment | |||||||
|
link
|
0..* | BackboneElement |
An
associated
device,
attached
to,
used
with,
communicating
with
or
linking
a
previous
or
new
device
model
to
the
focal
device
|
|||||
|
relation
|
1..1 | Coding |
The
type
indicates
the
relationship
of
the
related
device
to
the
device
instance
Binding: Device Definition Relation Type ( Extensible ) |
|||||
|
relatedDevice[x]
|
1..1 |
A
reference
to
the
linked
device
Binding: Device Type ( Example ) |
||||||
|
relatedDeviceCanonical
| canonical ( DeviceDefinition ) |
|
||||||
|
relatedDeviceCodeableConcept
| CodeableConcept | |||||||
|
note
|
0..* | Annotation |
Device
notes
and
comments
|
|||||
|
material
|
0..* | BackboneElement |
A
substance
used
to
create
the
material(s)
of
which
the
device
is
made
|
|||||
|
substance
|
1..1 | CodeableConcept |
A
relevant
substance
that
the
device
contains,
may
contain,
or
is
made
of
Binding: Substance Code ( Example ) |
|||||
|
alternate
|
0..1 | boolean |
Indicates
an
alternative
material
of
the
device
|
|||||
|
allergenicIndicator
|
0..1 | boolean |
Whether
the
substance
is
a
known
or
suspected
allergen
|
|||||
|
productionIdentifierInUDI
|
0..* |
|
lot-number
|
manufactured-date
|
serial-number
|
expiration-date
|
biological-source
|
software-version
Binding: Device Production Identifier In UDI ( |
|||||
|
guideline
|
0..1 | BackboneElement |
Information
aimed
at
providing
directions
for
the
usage
of
this
model
of
device
|
|||||
|
useContext
|
0..* | UsageContext |
The
circumstances
that
form
the
setting
for
using
the
device
|
|||||
|
usageInstruction
|
0..1 | markdown |
Detailed
written
and
visual
directions
for
the
user
on
how
to
use
the
device
|
|||||
|
relatedArtifact
|
0..* | RelatedArtifact |
A
source
of
information
or
reference
for
this
guideline
|
|||||
|
indication
|
0..* | CodeableConcept |
A
clinical
condition
for
which
the
device
was
designed
to
be
used
|
|||||
|
contraindication
|
0..* | CodeableConcept |
A
specific
situation
when
a
device
should
not
be
used
because
it
may
cause
harm
|
|||||
|
warning
|
0..* | CodeableConcept |
Specific
hazard
alert
information
that
a
user
needs
to
know
before
using
the
device
|
|||||
|
intendedUse
|
0..1 | string |
A
description
of
the
general
purpose
or
medical
use
of
the
device
or
its
function
|
|||||
|
correctiveAction
|
0..1 | BackboneElement |
Tracking
of
latest
field
safety
corrective
action
|
|||||
|
recall
|
1..1 | boolean |
Whether
the
corrective
action
was
a
recall
|
|||||
|
scope
|
0..1 | code |
model
|
lot-numbers
|
serial-numbers
Binding: Device Corrective Action Scope ( Required ) |
|||||
|
period
|
1..1 | Period |
Start
and
end
dates
of
the
corrective
action
|
|||||
|
chargeItem
|
0..* | BackboneElement |
Billing
code
or
reference
associated
with
the
device
|
|||||
|
chargeItemCode
|
1..1 |
CodeableReference
|
The
code
or
reference
for
the
charge
item
Binding: USCLS Codes ( Example ) |
|||||
|
count
|
1..1 | Quantity |
Coefficient
applicable
to
the
billing
code
|
|||||
|
effectivePeriod
|
0..1 | Period |
A
specific
time
period
in
which
this
charge
item
applies
|
|||||
|
useContext
|
0..* | UsageContext |
The
context
to
which
this
charge
item
applies
|
|||||
|
Documentation
for
this
format
|
||||||||
See the Extensions for this resource
XML Template
<<DeviceDefinition xmlns="http://hl7.org/fhir">< <</identifier> <<url value="[uri]"/><!-- 0..1 Canonical identifier for this DeviceDefinition, represented as an absolute URI (globally unique) --> <identifier><!-- 0..* Identifier Additional identifier for the DeviceDefinition --></identifier> <version value="[string]"/><!-- 0..1 Business version of the DeviceDefinition --> <versionAlgorithm[x]><!-- 0..1 string|Coding How to compare versions --></versionAlgorithm[x]> <name value="[string]"/><!-- 0..1 Name for this DeviceDefinition (computer friendly) --> <title value="[string]"/><!-- 0..1 Name for this DeviceDefinition (human friendly) --> <status value="[code]"/><!-- 1..1 draft | active | retired | unknown --> <experimental value="[boolean]"/><!-- 0..1 For testing only - never for real usage --> <partNumber value="[string]"/><!-- 0..1 The part number or catalog number of the device --> <manufacturer><!-- 0..1 Reference(Organization) Name of device manufacturer --></manufacturer> <modelNumber value="[string]"/><!-- 0..1 The catalog or model number for the device for example as defined by the manufacturer --> <date value="[dateTime]"/><!-- 0..1 Date last changed --> <contact><!-- 0..* ContactDetail Contact details for the publisher --></contact> <publisher value="[string]"/><!-- 0..1 The name of the organization responsible for publishing the definition --> <useContext><!-- 0..* UsageContext The context that the content is intended to support --></useContext> <jurisdiction><!-- 0..* CodeableConcept Jurisdiction of the authority that maintains the DeviceDefinition (if applicable)<<identifier value="[string]"/><!-- 1..1 The identifier itself --> <issuer value="[uri]"/><!-- 1..1 The organization that issued this identifier --><<jurisdiction value="[uri]"/><!-- 1..1 Relevant jurisdiction governing the identifier --> <identifierSystem value="[uri]"/><!-- 0..1 The namespace for the device identifier value --> </regulatoryIdentifier>< <</manufacturer><deviceName> <!-- 0..* The name or names of the device as given by the manufacturer --> <name value="[string]"/><!-- 1..1 A name that is used to refer to the device --><<a href="devicedefinition-definitions.html#DeviceDefinition.deviceName.type" title="The type of deviceName. RegisteredName | UserFriendlyName | PatientReportedName." class="dict"><type><!-- 1..1 CodeableConcept registered-name | user-friendly-name | patient-reported-name --></type> </deviceName><<classification> <!-- 0..* What kind of device or device system this is --> <type><!-- 1..1 CodeableConcept A classification or risk class of the device model --></type> <justification><!-- 0..* RelatedArtifact Further information qualifying this classification of the device model --></justification> </classification> <conformsTo> <!-- 0..* Identifies the standards, specifications, or formal guidances for the capabilities supported by the device --> <category><!-- 0..1 CodeableConcept Describes the common type of the standard, specification, or formal guidance --></category> <specification><!-- 1..1 CodeableConcept Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type --></specification> <version value="[string]"/><!-- 0..* The specific form or variant of the standard, specification or formal guidance --> <source><!-- 0..* RelatedArtifact Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance --></source> </conformsTo> <hasPart> <!-- 0..* A device, part of the current one --><</reference><definition[x]><!-- 1..1 canonical(DeviceDefinition)|CodeableConcept Reference to the part --></definition[x]> <count value="[integer]"/><!-- 0..1 Number of occurrences of the part --> </hasPart> <packaging> <!-- 0..* Information about the packaging of the device, i.e. how the device is packaged --> <identifier><!-- 0..1 Identifier Business identifier of the packaged medication --></identifier> <type><!-- 0..1 CodeableConcept A code that defines the specific type of packaging --></type> <count value="[integer]"/><!-- 0..1 The number of items contained in the package (devices or sub-packages) --> <distributor> <!-- 0..* An organization that distributes the packaged device --> <name value="[string]"/><!-- 0..1 Distributor's human-readable name --> <organizationReference><!-- 0..* Reference(Organization) Distributor as an Organization resource --></organizationReference> </distributor> <udiDeviceIdentifier><!-- 0..* Content as for DeviceDefinition.udiDeviceIdentifier Unique Device Identifier (UDI) Barcode string on the packaging --></udiDeviceIdentifier> <packaging><!-- 0..* Content as for DeviceDefinition.packaging Allows packages within packages --></packaging> </packaging>< <</type> <</component> < </version><deviceVersion> <!-- 0..* The version of the device or software --> <type><!-- 0..1 CodeableConcept The type of the device version, e.g. manufacturer, approved, internal --></type> <component><!-- 0..1 Identifier The hardware or software module of the device to which the version applies --></component> <value value="[string]"/><!-- 1..1 The version text --> </deviceVersion> <safety><!-- 0..* CodeableConcept Safety characteristics of the device --></safety> <shelfLifeStorage><!-- 0..* ProductShelfLife Shelf Life and storage information --></shelfLifeStorage><</languageCode><outputLanguage value="[code]"/><!-- 0..* Language code for the human-readable text strings produced by the device (all supported) --> <property> <!-- 0..* Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc --> <type><!-- 1..1 CodeableConcept Code that specifies the property being represented --></type> <value[x]><!-- 1..1 Quantity|CodeableConcept|string|boolean|integer|Range| Attachment Value of the property --></value[x]> </property><</owner> <</contact><link> <!-- 0..* An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device --> <relation><!-- 1..1 Coding The type indicates the relationship of the related device to the device instance --></relation><</relatedDevice><relatedDevice[x]><!-- 1..1 canonical(DeviceDefinition)|CodeableConcept A reference to the linked device --></relatedDevice[x]> </link> <note><!-- 0..* Annotation Device notes and comments --></note> <material> <!-- 0..* A substance used to create the material(s) of which the device is made --><</substance><substance><!-- 1..1 CodeableConcept A relevant substance that the device contains, may contain, or is made of --></substance> <alternate value="[boolean]"/><!-- 0..1 Indicates an alternative material of the device --> <allergenicIndicator value="[boolean]"/><!-- 0..1 Whether the substance is a known or suspected allergen --> </material><<productionIdentifierInUDI><!-- 0..* CodeableConcept lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version --></productionIdentifierInUDI> <guideline> <!-- 0..1 Information aimed at providing directions for the usage of this model of device --> <useContext><!-- 0..* UsageContext The circumstances that form the setting for using the device --></useContext> <usageInstruction value="[markdown]"/><!-- 0..1 Detailed written and visual directions for the user on how to use the device --> <relatedArtifact><!-- 0..* RelatedArtifact A source of information or reference for this guideline --></relatedArtifact> <indication><!-- 0..* CodeableConcept A clinical condition for which the device was designed to be used --></indication> <contraindication><!-- 0..* CodeableConcept A specific situation when a device should not be used because it may cause harm --></contraindication> <warning><!-- 0..* CodeableConcept Specific hazard alert information that a user needs to know before using the device --></warning> <intendedUse value="[string]"/><!-- 0..1 A description of the general purpose or medical use of the device or its function --> </guideline> <correctiveAction> <!-- 0..1 Tracking of latest field safety corrective action --> <recall value="[boolean]"/><!-- 1..1 Whether the corrective action was a recall --> <scope value="[code]"/><!-- 0..1 model | lot-numbers | serial-numbers --> <period><!-- 1..1 Period Start and end dates of the corrective action --></period> </correctiveAction> <chargeItem> <!-- 0..* Billing code or reference associated with the device --><</chargeItemCode><chargeItemCode><!-- 1..1 CodeableReference The code or reference for the charge item --></chargeItemCode> <count><!-- 1..1 Quantity Coefficient applicable to the billing code --></count> <effectivePeriod><!-- 0..1 Period A specific time period in which this charge item applies --></effectivePeriod> <useContext><!-- 0..* UsageContext The context to which this charge item applies --></useContext> </chargeItem> </DeviceDefinition>
JSON Template
{
"resourceType" : "",
"resourceType" : "DeviceDefinition",
// from Resource: id, meta, implicitRules, and language
// from DomainResource: text, contained, extension, and modifierExtension
"
"
"
"url" : "<uri>", // Canonical identifier for this DeviceDefinition, represented as an absolute URI (globally unique)
"identifier" : [{ Identifier }], // Additional identifier for the DeviceDefinition
"version" : "<string>", // Business version of the DeviceDefinition
// versionAlgorithm[x]: How to compare versions. One of these 2:
"versionAlgorithmString" : "<string>",
"versionAlgorithmCoding" : { Coding },
"name" : "<string>", // Name for this DeviceDefinition (computer friendly)
"title" : "<string>", // Name for this DeviceDefinition (human friendly)
"status" : "<code>", // R! draft | active | retired | unknown
"experimental" : <boolean>, // For testing only - never for real usage
"partNumber" : "<string>", // The part number or catalog number of the device
"manufacturer" : { Reference(Organization) }, // Name of device manufacturer
"modelNumber" : "<string>", // The catalog or model number for the device for example as defined by the manufacturer
"date" : "<dateTime>", // Date last changed
"contact" : [{ ContactDetail }], // Contact details for the publisher
"publisher" : "<string>", // The name of the organization responsible for publishing the definition
"useContext" : [{ UsageContext }], // The context that the content is intended to support
"jurisdiction" : [{ CodeableConcept }], // Jurisdiction of the authority that maintains the DeviceDefinition (if applicable)
"purpose" : "<markdown>", // Why this DeviceDefinition is defined
"copyright" : "<markdown>", // Notice about intellectual property ownership, can include restrictions on use
"copyrightLabel" : "<string>", // Copyright holder and year(s)
"udiDeviceIdentifier" : [{ // Unique Device Identifier (UDI) Barcode string
"deviceIdentifier" : "<string>", // R! The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier
"issuer" : "<uri>", // R! The organization that assigns the identifier algorithm
"jurisdiction" : "<uri>", // R! The jurisdiction to which the deviceIdentifier applies
"marketDistribution" : [{ // Indicates whether and when the device is available on the market
"marketPeriod" : { Period }, // R! Begin and end dates for the commercial distribution of the device
"subJurisdiction" : "<uri>" // R! National state or territory where the device is commercialized
}]
}],
"deviceIdentifierSystem" : "<uri>" // The namespace for the device identifier value
}],
"regulatoryIdentifier" : [{ // Regulatory identifier(s) associated with this device
"type" : "<code>", // R! basic | master | license
"
"identifier" : "<string>", // R! The identifier itself
"issuer" : "<uri>", // R! The organization that issued this identifier
"
"jurisdiction" : "<uri>", // R! Relevant jurisdiction governing the identifier
"identifierSystem" : "<uri>" // The namespace for the device identifier value
}],
"
"
"deviceName" : [{ // The name or names of the device as given by the manufacturer
"name" : "<string>", // R! A name that is used to refer to the device
"<a href="devicedefinition-definitions.html#DeviceDefinition.deviceName.type" title="The type of deviceName.
RegisteredName | UserFriendlyName | PatientReportedName." class="dict">type
"type" : { CodeableConcept } // R! registered-name | user-friendly-name | patient-reported-name
}],
"
"classification" : [{ // What kind of device or device system this is
"type" : { CodeableConcept }, // R! A classification or risk class of the device model
"justification" : [{ RelatedArtifact }] // Further information qualifying this classification of the device model
}],
"conformsTo" : [{ // Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
"category" : { CodeableConcept }, // Describes the common type of the standard, specification, or formal guidance
"specification" : { CodeableConcept }, // R! Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
"version" : ["<string>"], // The specific form or variant of the standard, specification or formal guidance
"source" : [{ RelatedArtifact }] // Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance
}],
"hasPart" : [{ // A device, part of the current one
"
// definition[x]: Reference to the part. One of these 2:
"definitionCanonical" : "<canonical(DeviceDefinition)>",
"definitionCodeableConcept" : { CodeableConcept },
"count" : <integer> // Number of occurrences of the part
}],
"packaging" : [{ // Information about the packaging of the device, i.e. how the device is packaged
"identifier" : { Identifier }, // Business identifier of the packaged medication
"type" : { CodeableConcept }, // A code that defines the specific type of packaging
"count" : <integer>, // The number of items contained in the package (devices or sub-packages)
"distributor" : [{ // An organization that distributes the packaged device
"name" : "<string>", // Distributor's human-readable name
"organizationReference" : [{ Reference(Organization) }] // Distributor as an Organization resource
}],
"udiDeviceIdentifier" : [{ Content as for DeviceDefinition.udiDeviceIdentifier }], // Unique Device Identifier (UDI) Barcode string on the packaging
"packaging" : [{ Content as for DeviceDefinition.packaging }] // Allows packages within packages
}],
"
"
"
"
"deviceVersion" : [{ // The version of the device or software
"type" : { CodeableConcept }, // The type of the device version, e.g. manufacturer, approved, internal
"component" : { Identifier }, // The hardware or software module of the device to which the version applies
"value" : "<string>" // R! The version text
}],
"safety" : [{ CodeableConcept }], // Safety characteristics of the device
"shelfLifeStorage" : [{ ProductShelfLife }], // Shelf Life and storage information
"
"outputLanguage" : ["<code>"], // Language code for the human-readable text strings produced by the device (all supported)
"property" : [{ // Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
"type" : { CodeableConcept }, // R! Code that specifies the property being represented
// value[x]: Value of the property. One of these 7:
"valueQuantity" : { Quantity },
"valueCodeableConcept" : { CodeableConcept },
"valueString" : "<string>",
"valueBoolean" : <boolean>,
"valueInteger" : <integer>,
"valueRange" : { Range },
"valueAttachment" : { Attachment }
}],
"
"
"link" : [{ // An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
"relation" : { Coding }, // R! The type indicates the relationship of the related device to the device instance
"
// relatedDevice[x]: A reference to the linked device. One of these 2:
"relatedDeviceCanonical" : "<canonical(DeviceDefinition)>",
"relatedDeviceCodeableConcept" : { CodeableConcept }
}],
"note" : [{ Annotation }], // Device notes and comments
"material" : [{ // A substance used to create the material(s) of which the device is made
"
"substance" : { CodeableConcept }, // R! A relevant substance that the device contains, may contain, or is made of
"alternate" : <boolean>, // Indicates an alternative material of the device
"allergenicIndicator" : <boolean> // Whether the substance is a known or suspected allergen
}],
"
"productionIdentifierInUDI" : [{ CodeableConcept }], // lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
"guideline" : { // Information aimed at providing directions for the usage of this model of device
"useContext" : [{ UsageContext }], // The circumstances that form the setting for using the device
"usageInstruction" : "<markdown>", // Detailed written and visual directions for the user on how to use the device
"relatedArtifact" : [{ RelatedArtifact }], // A source of information or reference for this guideline
"indication" : [{ CodeableConcept }], // A clinical condition for which the device was designed to be used
"contraindication" : [{ CodeableConcept }], // A specific situation when a device should not be used because it may cause harm
"warning" : [{ CodeableConcept }], // Specific hazard alert information that a user needs to know before using the device
"intendedUse" : "<string>" // A description of the general purpose or medical use of the device or its function
},
"correctiveAction" : { // Tracking of latest field safety corrective action
"recall" : <boolean>, // R! Whether the corrective action was a recall
"scope" : "<code>", // model | lot-numbers | serial-numbers
"period" : { Period } // R! Start and end dates of the corrective action
},
"chargeItem" : [{ // Billing code or reference associated with the device
"
"chargeItemCode" : { CodeableReference }, // R! The code or reference for the charge item
"count" : { Quantity }, // R! Coefficient applicable to the billing code
"effectivePeriod" : { Period }, // A specific time period in which this charge item applies
"useContext" : [{ UsageContext }] // The context to which this charge item applies
}]
}
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> .[ a fhir:;[ a fhir:DeviceDefinition; fhir:nodeRole fhir:treeRoot; # if this is the parser root# from # from fhir: fhir: fhir:# from Resource: fhir:id, fhir:meta, fhir:implicitRules, and fhir:language # from DomainResource: fhir:text, fhir:contained, fhir:extension, and fhir:modifierExtension fhir:url [ uri ] ; # 0..1 Canonical identifier for this DeviceDefinition, represented as an absolute URI (globally unique) fhir:identifier ( [ Identifier ] ... ) ; # 0..* Additional identifier for the DeviceDefinition fhir:version [ string ] ; # 0..1 Business version of the DeviceDefinition # versionAlgorithm[x] : 0..1 How to compare versions. One of these 2 fhir:versionAlgorithm [ a fhir:String ; string ] fhir:versionAlgorithm [ a fhir:Coding ; Coding ] fhir:name [ string ] ; # 0..1 Name for this DeviceDefinition (computer friendly) fhir:title [ string ] ; # 0..1 Name for this DeviceDefinition (human friendly) fhir:status [ code ] ; # 1..1 draft | active | retired | unknown fhir:experimental [ boolean ] ; # 0..1 For testing only - never for real usage fhir:partNumber [ string ] ; # 0..1 The part number or catalog number of the device fhir:manufacturer [ Reference(Organization) ] ; # 0..1 Name of device manufacturer fhir:modelNumber [ string ] ; # 0..1 The catalog or model number for the device for example as defined by the manufacturer fhir:date [ dateTime ] ; # 0..1 Date last changed fhir:contact ( [ ContactDetail ] ... ) ; # 0..* Contact details for the publisher fhir:publisher [ string ] ; # 0..1 The name of the organization responsible for publishing the definition fhir:useContext ( [ UsageContext ] ... ) ; # 0..* The context that the content is intended to support fhir:jurisdiction ( [ CodeableConcept ] ... ) ; # 0..* Jurisdiction of the authority that maintains the DeviceDefinition (if applicable) fhir:purpose [ markdown ] ; # 0..1 Why this DeviceDefinition is defined fhir:copyright [ markdown ] ; # 0..1 Notice about intellectual property ownership, can include restrictions on use fhir:copyrightLabel [ string ] ; # 0..1 Copyright holder and year(s) fhir:udiDeviceIdentifier ( [ # 0..* Unique Device Identifier (UDI) Barcode string fhir:deviceIdentifier [ string ] ; # 1..1 The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier fhir:issuer [ uri ] ; # 1..1 The organization that assigns the identifier algorithm fhir:jurisdiction [ uri ] ; # 1..1 The jurisdiction to which the deviceIdentifier applies fhir:marketDistribution ( [ # 0..* Indicates whether and when the device is available on the market fhir:marketPeriod [ Period ] ; # 1..1 Begin and end dates for the commercial distribution of the device fhir:subJurisdiction [ uri ] ; # 1..1 National state or territory where the device is commercialized ] ... ) ; fhir:deviceIdentifierSystem [ uri ] ; # 0..1 The namespace for the device identifier value ] ... ) ; fhir:regulatoryIdentifier ( [ # 0..* Regulatory identifier(s) associated with this device fhir:type [ code ] ; # 1..1 basic | master | licensefhir:fhir:identifier [ string ] ; # 1..1 The identifier itself fhir:issuer [ uri ] ; # 1..1 The organization that issued this identifierfhir:fhir:jurisdiction [ uri ] ; # 1..1 Relevant jurisdiction governing the identifier fhir:identifierSystem [ uri ] ; # 0..1 The namespace for the device identifier value ] ... ) ;fhir: fhir:fhir:deviceName ( [ # 0..* The name or names of the device as given by the manufacturer fhir:name [ string ] ; # 1..1 A name that is used to refer to the devicefhir:<a href="devicedefinition-definitions.html#DeviceDefinition.deviceName.type" title="The type of deviceName. RegisteredName | UserFriendlyName | PatientReportedName." class="dict">typefhir:type [ CodeableConcept ] ; # 1..1 registered-name | user-friendly-name | patient-reported-name ] ... ) ;fhir:fhir:classification ( [ # 0..* What kind of device or device system this is fhir:type [ CodeableConcept ] ; # 1..1 A classification or risk class of the device model fhir:justification ( [ RelatedArtifact ] ... ) ; # 0..* Further information qualifying this classification of the device model ] ... ) ; fhir:conformsTo ( [ # 0..* Identifies the standards, specifications, or formal guidances for the capabilities supported by the device fhir:category [ CodeableConcept ] ; # 0..1 Describes the common type of the standard, specification, or formal guidance fhir:specification [ CodeableConcept ] ; # 1..1 Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type fhir:version ( [ string ] ... ) ; # 0..* The specific form or variant of the standard, specification or formal guidance fhir:source ( [ RelatedArtifact ] ... ) ; # 0..* Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance ] ... ) ; fhir:hasPart ( [ # 0..* A device, part of the current onefhir:# definition[x] : 1..1 Reference to the part. One of these 2 fhir:definition [ a fhir:Canonical ; canonical(DeviceDefinition) ] fhir:definition [ a fhir:CodeableConcept ; CodeableConcept ] fhir:count [ integer ] ; # 0..1 Number of occurrences of the part ] ... ) ; fhir:packaging ( [ # 0..* Information about the packaging of the device, i.e. how the device is packaged fhir:identifier [ Identifier ] ; # 0..1 Business identifier of the packaged medication fhir:type [ CodeableConcept ] ; # 0..1 A code that defines the specific type of packaging fhir:count [ integer ] ; # 0..1 The number of items contained in the package (devices or sub-packages) fhir:distributor ( [ # 0..* An organization that distributes the packaged device fhir:name [ string ] ; # 0..1 Distributor's human-readable name fhir:organizationReference ( [ Reference(Organization) ] ... ) ; # 0..* Distributor as an Organization resource ] ... ) ; fhir:udiDeviceIdentifier ( [ See DeviceDefinition.udiDeviceIdentifier ] ... ) ; # 0..* Unique Device Identifier (UDI) Barcode string on the packaging fhir:packaging ( [ See DeviceDefinition.packaging ] ... ) ; # 0..* Allows packages within packages ] ... ) ;fhir: fhir: fhir: fhir:fhir:deviceVersion ( [ # 0..* The version of the device or software fhir:type [ CodeableConcept ] ; # 0..1 The type of the device version, e.g. manufacturer, approved, internal fhir:component [ Identifier ] ; # 0..1 The hardware or software module of the device to which the version applies fhir:value [ string ] ; # 1..1 The version text ] ... ) ; fhir:safety ( [ CodeableConcept ] ... ) ; # 0..* Safety characteristics of the device fhir:shelfLifeStorage ( [ ProductShelfLife ] ... ) ; # 0..* Shelf Life and storage informationfhir:fhir:outputLanguage ( [ code ] ... ) ; # 0..* Language code for the human-readable text strings produced by the device (all supported) fhir:property ( [ # 0..* Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc fhir:type [ CodeableConcept ] ; # 1..1 Code that specifies the property being represented # value[x] : 1..1 Value of the property. One of these 7 fhir:value [ a fhir:Quantity ; Quantity ] fhir:value [ a fhir:CodeableConcept ; CodeableConcept ]fhir: ] fhir: ] fhir: ]fhir:value [ a fhir:String ; string ] fhir:value [ a fhir:Boolean ; boolean ] fhir:value [ a fhir:Integer ; integer ] fhir:value [ a fhir:Range ; Range ] fhir:value [ a fhir:Attachment ; Attachment ] ] ... ) ;fhir: fhir:fhir:link ( [ # 0..* An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device fhir:relation [ Coding ] ; # 1..1 The type indicates the relationship of the related device to the device instancefhir:# relatedDevice[x] : 1..1 A reference to the linked device. One of these 2 fhir:relatedDevice [ a fhir:Canonical ; canonical(DeviceDefinition) ] fhir:relatedDevice [ a fhir:CodeableConcept ; CodeableConcept ] ] ... ) ; fhir:note ( [ Annotation ] ... ) ; # 0..* Device notes and comments fhir:material ( [ # 0..* A substance used to create the material(s) of which the device is made fhir:substance [ CodeableConcept ] ; # 1..1 A relevant substance that the device contains, may contain, or is made of fhir:alternate [ boolean ] ; # 0..1 Indicates an alternative material of the device fhir:allergenicIndicator [ boolean ] ; # 0..1 Whether the substance is a known or suspected allergen ] ... ) ;fhir:fhir:productionIdentifierInUDI ( [ CodeableConcept ] ... ) ; # 0..* lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version fhir:guideline [ # 0..1 Information aimed at providing directions for the usage of this model of device fhir:useContext ( [ UsageContext ] ... ) ; # 0..* The circumstances that form the setting for using the device fhir:usageInstruction [ markdown ] ; # 0..1 Detailed written and visual directions for the user on how to use the device fhir:relatedArtifact ( [ RelatedArtifact ] ... ) ; # 0..* A source of information or reference for this guideline fhir:indication ( [ CodeableConcept ] ... ) ; # 0..* A clinical condition for which the device was designed to be used fhir:contraindication ( [ CodeableConcept ] ... ) ; # 0..* A specific situation when a device should not be used because it may cause harm fhir:warning ( [ CodeableConcept ] ... ) ; # 0..* Specific hazard alert information that a user needs to know before using the device fhir:intendedUse [ string ] ; # 0..1 A description of the general purpose or medical use of the device or its function ] ; fhir:correctiveAction [ # 0..1 Tracking of latest field safety corrective action fhir:recall [ boolean ] ; # 1..1 Whether the corrective action was a recall fhir:scope [ code ] ; # 0..1 model | lot-numbers | serial-numbers fhir:period [ Period ] ; # 1..1 Start and end dates of the corrective action ] ; fhir:chargeItem ( [ # 0..* Billing code or reference associated with the devicefhir:fhir:chargeItemCode [ CodeableReference ] ; # 1..1 The code or reference for the charge item fhir:count [ Quantity ] ; # 1..1 Coefficient applicable to the billing code fhir:effectivePeriod [ Period ] ; # 0..1 A specific time period in which this charge item applies fhir:useContext ( [ UsageContext ] ... ) ; # 0..* The context to which this charge item applies ] ... ) ; ]
Changes from both R4 and R4B
| DeviceDefinition | |
| DeviceDefinition.version |
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| DeviceDefinition.status |
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| DeviceDefinition.experimental |
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| DeviceDefinition.manufacturer |
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| DeviceDefinition.date |
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| DeviceDefinition.contact |
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| DeviceDefinition.publisher |
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| DeviceDefinition.jurisdiction |
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| DeviceDefinition.purpose |
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| DeviceDefinition.copyrightLabel |
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| DeviceDefinition.udiDeviceIdentifier.marketDistribution |
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| DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod |
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| DeviceDefinition.udiDeviceIdentifier.deviceIdentifierSystem |
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| DeviceDefinition.regulatoryIdentifier.type |
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| DeviceDefinition.regulatoryIdentifier.identifierSystem |
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| DeviceDefinition.deviceName.type |
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| DeviceDefinition.classification |
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| DeviceDefinition.classification.type |
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| DeviceDefinition.classification.justification |
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| DeviceDefinition.conformsTo |
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| DeviceDefinition.conformsTo.category |
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| DeviceDefinition.conformsTo.specification |
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| DeviceDefinition.conformsTo.version |
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| DeviceDefinition.conformsTo.source |
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| DeviceDefinition.hasPart |
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| DeviceDefinition.hasPart.count |
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| DeviceDefinition.packaging |
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| DeviceDefinition.packaging.identifier |
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| DeviceDefinition.packaging.type |
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| DeviceDefinition.packaging.count |
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| DeviceDefinition.packaging.distributor |
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| DeviceDefinition.packaging.distributor.name |
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| DeviceDefinition.packaging.distributor.organizationReference |
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| DeviceDefinition.packaging.udiDeviceIdentifier |
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| DeviceDefinition.packaging.packaging |
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| DeviceDefinition.outputLanguage |
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| DeviceDefinition.property.value[x] |
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| DeviceDefinition.link |
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| DeviceDefinition.link.relation |
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| DeviceDefinition.productionIdentifierInUDI |
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| DeviceDefinition.guideline |
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| DeviceDefinition.guideline.useContext |
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| DeviceDefinition.guideline.usageInstruction |
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| DeviceDefinition.guideline.relatedArtifact |
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| DeviceDefinition.guideline.indication |
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| DeviceDefinition.guideline.contraindication |
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| DeviceDefinition.guideline.warning |
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| DeviceDefinition.guideline.intendedUse |
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| DeviceDefinition.correctiveAction |
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| DeviceDefinition.correctiveAction.recall |
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| DeviceDefinition.correctiveAction.scope |
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| DeviceDefinition.correctiveAction.period |
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| DeviceDefinition.chargeItem |
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| DeviceDefinition.chargeItem.chargeItemCode |
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| DeviceDefinition.chargeItem.count |
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| DeviceDefinition.chargeItem.effectivePeriod |
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| DeviceDefinition.chargeItem.useContext |
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| DeviceDefinition.specialization.systemType |
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| DeviceDefinition.physicalCharacteristics |
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| DeviceDefinition.languageCode |
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| DeviceDefinition.capability |
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| DeviceDefinition.property.valueQuantity |
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| DeviceDefinition.property.valueCode |
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| DeviceDefinition.quantity |
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| DeviceDefinition.parentDevice |
|
See the Full Difference for further information
This analysis is available for R4 as XML or JSON and for R4B as XML or JSON .
Additional
definitions:
Master
Definition
XML
+
JSON
,
XML
Schema
/
Schematron
+
JSON
Schema
,
ShEx
(for
Turtle
)
+
see
the
extensions
,
,
the
spreadsheet
version
&
the
dependency
analysis
| Path | ValueSet | Type | Documentation |
|---|---|---|---|
| DeviceDefinition.versionAlgorithm[x] | VersionAlgorithm | Extensible | Indicates the mechanism used to compare versions to determine which is more current. |
| DeviceDefinition.status | PublicationStatus | Required | The lifecycle status of an artifact. |
| DeviceDefinition.jurisdiction |
JurisdictionValueSet
| Extensible | This value set defines a base set of codes for country, country subdivision and region for indicating where a resource is intended to be used.
Note:
The
codes
for
countries
and
country
subdivisions
are
taken
from
ISO
3166
|
| DeviceDefinition.regulatoryIdentifier.type | DeviceDefinitionRegulatoryIdentifierType (a valid code from Device Regulatory Identifier Type ) | Required |
Regulatory Identifier type |
| DeviceDefinition.deviceName.type | DeviceNameType |
|
The type of name the device is referred by. |
| DeviceDefinition.classification.type | DeviceType | Example |
Codes used to identify medical devices. Includes concepts from SNOMED CT (http://www.snomed.org/) where concept is-a 49062001 (Device) and is provided as a suggestive example. |
| DeviceDefinition.conformsTo.category | DeviceSpecificationCategory (a valid code from FHIR Device Specialization Category ) | Example |
The kind of standards used by the device. |
| DeviceDefinition.conformsTo.specification | DeviceSpecificationType | Example |
The type or specification of a standard that devices can adhere to |
| DeviceDefinition.hasPart.definition[x] | DeviceType | Example | Codes used to identify medical devices. Includes concepts from SNOMED CT (http://www.snomed.org/) where concept is-a 49062001 (Device) and is provided as a suggestive example. |
| DeviceDefinition.safety | DeviceSafety | Example |
Codes
used
to
identify
medical
devices
safety
characteristics.
These
codes
are
taken
from
the
NCI
Thesaurus
|
| DeviceDefinition.outputLanguage |
AllLanguages
(a
valid
code
from
urn:ietf:bcp:47
)
| Required | This value set includes all possible codes from BCP-47 (see http://tools.ietf.org/html/bcp47) |
| Common Languages | starter | ||
| DeviceDefinition.property.type |
|
Example |
The fixed characteristics or conditions of the device. These codes are for example purposes only. |
| DeviceDefinition.link.relation | DeviceDefinitionRelationType | Extensible | Description Needed Here |
| DeviceDefinition.link.relatedDevice[x] | DeviceType | Example |
Codes used to identify medical devices. Includes concepts from SNOMED CT (http://www.snomed.org/) where concept is-a 49062001 (Device) and is provided as a suggestive example. |
| DeviceDefinition.material.substance |
|
|
|
| DeviceDefinition.productionIdentifierInUDI | DeviceProductionIdentifierInUDI |
|
Device Production Identifier in UDI |
| DeviceDefinition.correctiveAction.scope | DeviceCorrectiveActionScope | Required |
Device - Corrective action scope |
| DeviceDefinition.chargeItem.chargeItemCode | USCLSCodes | Example | This value set includes a smattering of USCLS codes. |
| UniqueKey | Level | Location | Description | Expression |
cnl-1
| Warning | DeviceDefinition.url | URL should not contain | or # - these characters make processing canonical references problematic | exists() implies matches('^[^|# ]+$') |
Search parameters for this resource. See also the full list of search parameters for this resource , and check the Extensions registry for search parameters on extensions related to this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.
| Name | Type | Description | Expression | In Common |
| conforms-to-category | token | The category of the conformance | DeviceDefinition.conformsTo.category | |
| device-name | string | A server defined search that may match any of the string fields in DeviceDefinition.name or DeviceDefinition.classification.type - the latter to search for 'generic' devices. | DeviceDefinition.deviceName.name | DeviceDefinition.classification.type.coding.display | DeviceDefinition.classification.type.text | |
| experimental | token | Whether the DeviceDefinition is experimental | DeviceDefinition.experimental | |
| has-part-canonical |
reference
|
The component part device definition |
DeviceDefinition.hasPart.definition.ofType(canonical)
( DeviceDefinition ) | |
| has-part-code | token | The component part device type | DeviceDefinition.hasPart.definition.ofType(CodeableConcept) | |
| identifier | token | The identifier of the component | DeviceDefinition.identifier | DeviceDefinition.udiDeviceIdentifier | 28 Resources |
| manufacturer | reference | The manufacturer of the device |
DeviceDefinition.manufacturer
( Organization ) |
|
| model-number |
token
|
The model of the device | DeviceDefinition.modelNumber | |
| part-number | string | The part number or catalog number of the device. | DeviceDefinition.partNumber |
|
| publisher | string |
The
|
|
25 Resources |
| specification | token | The specification that the device conforms to | DeviceDefinition.conformsTo.specification | |
| specification-version | composite | A composite of both specification and version |
On
DeviceDefinition.conformsTo:
specification: specification version: version |
|
| type | token | The device type | DeviceDefinition.classification.type | |
| url |
| The uri that identifies the code system | DeviceDefinition.url | 29 Resources |
| version | token | The specific version of the device | DeviceDefinition.deviceVersion.value | 26 Resources |
| version-type | composite | Value and type of version |
On
DeviceDefinition.deviceVersion:
type: type value: value |
FHIR
®©
HL7.org
2011+.
FHIR
R5
hl7.fhir.core#5.0.0
R6
hl7.fhir.core#6.0.0-ballot3
generated
on
Sun,
Mar
26,
2023
15:24+1100.
Fri,
Nov
21,
2025
00:01+0000.
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