| <?xml version="1.0" encoding="UTF-8"?>
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| <!--
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| Copyright (c) 2011+, HL7, Inc.
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| All rights reserved.
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| Redistribution and use in source and binary forms, with or without modification,
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| are permitted provided that the following conditions are met:
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| * Redistributions of source code must retain the above copyright notice, this
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| list of conditions and the following disclaimer.
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| * Redistributions in binary form must reproduce the above copyright notice,
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| this list of conditions and the following disclaimer in the documentation
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| and/or other materials provided with the distribution.
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| * Neither the name of HL7 nor the names of its contributors may be used to
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| endorse or promote products derived from this software without specific
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| prior written permission.
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| THIS SOFTWARE IS PROVIDED BY THE COPYRIGHT HOLDERS AND CONTRIBUTORS "AS IS" AND
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| ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED
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| WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED.
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| IN NO EVENT SHALL THE COPYRIGHT HOLDER OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT,
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| WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE)
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| ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE
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| POSSIBILITY OF SUCH DAMAGE.
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| Generated on Thu, Dec 27, 2018 22:37+1100 for FHIR v4.0.0
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|
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| Note: the schemas & schematrons do not contain all of the rules about what makes resources
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| valid. Implementers will still need to be familiar with the content of the specification and with
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| any profiles that apply to the resources in order to make a conformant implementation.
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| -->
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| <xs:schema xmlns:xs="http://www.w3.org/2001/XMLSchema" xmlns="http://hl7.org/fhir" xmlns:xhtml="http://www.w3.org/1999/xhtml" targetNamespace="http://hl7.org/fhir" elementFormDefault="qualified" version="1.0">
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| <xs:include schemaLocation="fhir-base.xsd"/>
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| <xs:element name="DeviceDefinition" type="DeviceDefinition">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">The characteristics, operational status and capabilities of a medical-related component of a medical device.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| <xs:complexType name="DeviceDefinition">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">The characteristics, operational status and capabilities of a medical-related component of a medical device.</xs:documentation>
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| <xs:documentation xml:lang="en">If the element is present, it must have either a @value, an @id, or extensions</xs:documentation>
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| </xs:annotation>
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| <xs:complexContent>
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| <xs:extension base="DomainResource">
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| <xs:sequence>
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| <xs:element name="identifier" minOccurs="0" maxOccurs="unbounded" type="Identifier">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">Unique instance identifiers assigned to a device by the software, manufacturers, other organizations or owners. For example: handle ID.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| <xs:element name="udiDeviceIdentifier" type="DeviceDefinition.UdiDeviceIdentifier" minOccurs="0" maxOccurs="unbounded">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| <xs:choice minOccurs="0" maxOccurs="1" >
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| <xs:annotation>
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| <xs:documentation xml:lang="en">A name of the manufacturer.</xs:documentation>
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| </xs:annotation>
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| <xs:element name="manufacturerString" type="string"/>
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| <xs:element name="manufacturerReference" type="Reference"/>
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| </xs:choice>
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| <xs:element name="deviceName" type="DeviceDefinition.DeviceName" minOccurs="0" maxOccurs="unbounded">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">A name given to the device to identify it.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| <xs:element name="modelNumber" minOccurs="0" maxOccurs="1" type="string">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">The model number for the device.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| <xs:element name="type" minOccurs="0" maxOccurs="1" type="CodeableConcept">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">What kind of device or device system this is.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| <xs:element name="specialization" type="DeviceDefinition.Specialization" minOccurs="0" maxOccurs="unbounded">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| <xs:element name="version" minOccurs="0" maxOccurs="unbounded" type="string">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">The available versions of the device, e.g., software versions.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| <xs:element name="safety" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">Safety characteristics of the device.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| <xs:element name="shelfLifeStorage" minOccurs="0" maxOccurs="unbounded" type="ProductShelfLife">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">Shelf Life and storage information.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| <xs:element name="physicalCharacteristics" minOccurs="0" maxOccurs="1" type="ProdCharacteristic">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">Dimensions, color etc.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| <xs:element name="languageCode" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">Language code for the human-readable text strings produced by the device (all supported).</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| <xs:element name="capability" type="DeviceDefinition.Capability" minOccurs="0" maxOccurs="unbounded">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">Device capabilities.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| <xs:element name="property" type="DeviceDefinition.Property" minOccurs="0" maxOccurs="unbounded">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| <xs:element name="owner" minOccurs="0" maxOccurs="1" type="Reference">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">An organization that is responsible for the provision and ongoing maintenance of the device.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| <xs:element name="contact" minOccurs="0" maxOccurs="unbounded" type="ContactPoint">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">Contact details for an organization or a particular human that is responsible for the device.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| <xs:element name="url" minOccurs="0" maxOccurs="1" type="uri">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">A network address on which the device may be contacted directly.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| <xs:element name="onlineInformation" minOccurs="0" maxOccurs="1" type="uri">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">Access to on-line information about the device.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| <xs:element name="note" minOccurs="0" maxOccurs="unbounded" type="Annotation">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">Descriptive information, usage information or implantation information that is not captured in an existing element.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| <xs:element name="quantity" minOccurs="0" maxOccurs="1" type="Quantity">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">The quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product).</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| <xs:element name="parentDevice" minOccurs="0" maxOccurs="1" type="Reference">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">The parent device it can be part of.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| <xs:element name="material" type="DeviceDefinition.Material" minOccurs="0" maxOccurs="unbounded">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">A substance used to create the material(s) of which the device is made.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| </xs:sequence>
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| </xs:extension>
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| </xs:complexContent>
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| </xs:complexType>
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| <xs:complexType name="DeviceDefinition.UdiDeviceIdentifier">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">The characteristics, operational status and capabilities of a medical-related component of a medical device.</xs:documentation>
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| </xs:annotation>
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| <xs:complexContent>
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| <xs:extension base="BackboneElement">
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| <xs:sequence>
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| <xs:element name="deviceIdentifier" minOccurs="1" maxOccurs="1" type="string">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| <xs:element name="issuer" minOccurs="1" maxOccurs="1" type="uri">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">The organization that assigns the identifier algorithm.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| <xs:element name="jurisdiction" minOccurs="1" maxOccurs="1" type="uri">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">The jurisdiction to which the deviceIdentifier applies.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| </xs:sequence>
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| </xs:extension>
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| </xs:complexContent>
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| </xs:complexType>
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| <xs:complexType name="DeviceDefinition.DeviceName">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">The characteristics, operational status and capabilities of a medical-related component of a medical device.</xs:documentation>
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| </xs:annotation>
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| <xs:complexContent>
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| <xs:extension base="BackboneElement">
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| <xs:sequence>
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| <xs:element name="name" minOccurs="1" maxOccurs="1" type="string">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">The name of the device.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| <xs:element name="type" minOccurs="1" maxOccurs="1" type="DeviceNameType">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">The type of deviceName. |
| UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| </xs:sequence>
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| </xs:extension>
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| </xs:complexContent>
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| </xs:complexType>
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| <xs:complexType name="DeviceDefinition.Specialization">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">The characteristics, operational status and capabilities of a medical-related component of a medical device.</xs:documentation>
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| </xs:annotation>
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| <xs:complexContent>
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| <xs:extension base="BackboneElement">
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| <xs:sequence>
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| <xs:element name="systemType" minOccurs="1" maxOccurs="1" type="string">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">The standard that is used to operate and communicate.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| <xs:element name="version" minOccurs="0" maxOccurs="1" type="string">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">The version of the standard that is used to operate and communicate.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| </xs:sequence>
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| </xs:extension>
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| </xs:complexContent>
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| </xs:complexType>
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| <xs:complexType name="DeviceDefinition.Capability">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">The characteristics, operational status and capabilities of a medical-related component of a medical device.</xs:documentation>
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| </xs:annotation>
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| <xs:complexContent>
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| <xs:extension base="BackboneElement">
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| <xs:sequence>
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| <xs:element name="type" minOccurs="1" maxOccurs="1" type="CodeableConcept">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">Type of capability.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| <xs:element name="description" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">Description of capability.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| </xs:sequence>
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| </xs:extension>
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| </xs:complexContent>
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| </xs:complexType>
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| <xs:complexType name="DeviceDefinition.Property">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">The characteristics, operational status and capabilities of a medical-related component of a medical device.</xs:documentation>
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| </xs:annotation>
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| <xs:complexContent>
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| <xs:extension base="BackboneElement">
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| <xs:sequence>
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| <xs:element name="type" minOccurs="1" maxOccurs="1" type="CodeableConcept">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">Code that specifies the property DeviceDefinitionPropetyCode (Extensible).</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| <xs:element name="valueQuantity" minOccurs="0" maxOccurs="unbounded" type="Quantity">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">Property value as a quantity.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| <xs:element name="valueCode" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">Property value as a code, e.g., NTP4 (synced to NTP).</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| </xs:sequence>
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| </xs:extension>
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| </xs:complexContent>
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| </xs:complexType>
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| <xs:complexType name="DeviceDefinition.Material">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">The characteristics, operational status and capabilities of a medical-related component of a medical device.</xs:documentation>
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| </xs:annotation>
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| <xs:complexContent>
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| <xs:extension base="BackboneElement">
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| <xs:sequence>
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| <xs:element name="substance" minOccurs="1" maxOccurs="1" type="CodeableConcept">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">The substance.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| <xs:element name="alternate" minOccurs="0" maxOccurs="1" type="boolean">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">Indicates an alternative material of the device.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| <xs:element name="allergenicIndicator" minOccurs="0" maxOccurs="1" type="boolean">
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| <xs:annotation>
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| <xs:documentation xml:lang="en">Whether the substance is a known or suspected allergen.</xs:documentation>
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| </xs:annotation>
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| </xs:element>
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| </xs:sequence>
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| </xs:extension>
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| </xs:complexContent>
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| </xs:complexType>
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| </xs:schema>
|
