<?xml version="1.0" encoding="UTF-8"?>
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 * Copyright (C) 2014 - 2019 Health Level 7
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/*
  Copyright (c) 2011+, HL7, Inc.
  All rights reserved.
  
  Redistribution and use in source and binary forms, with or without modification, 
  are permitted provided that the following conditions are met:
  
   * Redistributions of source code must retain the above copyright notice, this 
     list of conditions and the following disclaimer.
   * Redistributions in binary form must reproduce the above copyright notice, 
     this list of conditions and the following disclaimer in the documentation 
     and/or other materials provided with the distribution.
   * Neither the name of HL7 nor the names of its contributors may be used to 
     endorse or promote products derived from this software without specific 
     prior written permission.
  
  THIS SOFTWARE IS PROVIDED BY THE COPYRIGHT HOLDERS AND CONTRIBUTORS "AS IS" AND 
  ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED 
  WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. 
  IN NO EVENT SHALL THE COPYRIGHT HOLDER OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, 
  INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT 
  NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR 
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  POSSIBILITY OF SUCH DAMAGE.
  

  Generated on Mon, Mar 30, 2026 16:23+0000 for FHIR v6.0.0-ballot4 

  Note: the schemas &amp; schematrons do not contain all of the rules about what makes resources
  valid. Implementers will still need to be familiar with the content of the specification and with
  any profiles that apply to the resources in order to make a conformant implementation.

-->
<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">
  <xs:include schemaLocation="fhir-base.xsd"/>
  <xs:element name="DeviceDefinition" type="DeviceDefinition">
    <xs:annotation>
      <xs:documentation xml:lang="en">The definition of a kind of device or device component. Typically, this definition corresponds to a device model although it may be a broader category of device.</xs:documentation>
    </xs:annotation>
  </xs:element>
  <xs:complexType name="DeviceDefinition">
    <xs:annotation>
      <xs:documentation xml:lang="en">The definition of a kind of device or device component. Typically, this definition corresponds to a device model although it may be a broader category of device.</xs:documentation>
      <xs:documentation xml:lang="en">If the element is present, it must have either a @value, an @id, or extensions</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="CanonicalResource">
        <xs:sequence>
          <xs:element name="url" minOccurs="0" maxOccurs="1" type="uri">
            <xs:annotation>
              <xs:documentation xml:lang="en">An absolute URI that is used to identify this DeviceDefinition when it is referenced in a specification, model, design or an instance; also called its canonical identifier.  This SHOULD be globally unique and SHOULD be a literal address at which an authoritative instance of this DeviceDefinition is (or will be) published. This URL can be the target of a canonical reference. It SHALL remain the same when the DeviceDefinition is stored on different servers.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="identifier" minOccurs="0" maxOccurs="unbounded" type="Identifier">
            <xs:annotation>
              <xs:documentation xml:lang="en">A formal identifier that is used to identify this DeviceDefinition when it is represented in other formats, or referenced in a specification, model, design or an instance.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="version" minOccurs="0" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">The identifier that is used to identify this version of the DeviceDefinition when it is referenced in a specification.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:choice minOccurs="0" maxOccurs="1" >
            <xs:annotation>
              <xs:documentation xml:lang="en">Indicates the mechanism used to compare versions to determine which is more current.</xs:documentation>
            </xs:annotation>
            <xs:element name="versionAlgorithmString" type="string"/>
            <xs:element name="versionAlgorithmCoding" type="Coding"/>
          </xs:choice>
          <xs:element name="name" minOccurs="0" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">A natural language name identifying the DeviceDefinition. This name should be usable as an identifier for the resource by machine processing applications such as code generation.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="title" minOccurs="0" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">A short, descriptive, user-friendly title for the DeviceDefinition.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="status" minOccurs="1" maxOccurs="1" type="PublicationStatus">
            <xs:annotation>
              <xs:documentation xml:lang="en">The current state of this DeviceDefinition.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="experimental" minOccurs="0" maxOccurs="1" type="boolean">
            <xs:annotation>
              <xs:documentation xml:lang="en">A Boolean value to indicate that this DeviceDefinition is authored for testing purposes (or education/evaluation/marketing) and no version of this resource will ever be intended for genuine usage.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="date" minOccurs="0" maxOccurs="1" type="dateTime">
            <xs:annotation>
              <xs:documentation xml:lang="en">The date (and optionally time) when the DeviceDefinition was last significantly changed. The date must change when the business version changes and it must change if the status code changes. In addition, it should change when the substantive content of the DeviceDefinition changes.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="publisher" minOccurs="0" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">The name of the organization or individual responsible for the release and ongoing maintenance of the DeviceDefinition.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="contact" minOccurs="0" maxOccurs="unbounded" type="ContactDetail">
            <xs:annotation>
              <xs:documentation xml:lang="en">Contact details to assist a user in finding and communicating with the publisher.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="description" minOccurs="0" maxOccurs="1" type="markdown">
            <xs:annotation>
              <xs:documentation xml:lang="en">A free text natural language description of the DeviceDefinition from a consumer's perspective.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="useContext" minOccurs="0" maxOccurs="unbounded" type="UsageContext">
            <xs:annotation>
              <xs:documentation xml:lang="en">The content was developed with a focus and intent of supporting the contexts that are listed. These contexts may be general categories (gender, age, ...) or may be references to specific programs (insurance plans, studies, ...) and may be used to assist with indexing and searching for appropriate DeviceDefinitions.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="jurisdiction" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">A legal or geographic region in which the authority that maintains the resource is operating.  In general, the jurisdiction is also found in the useContext.  The useContext may reference additional jurisdictions because the defining jurisdiction does not necessarily limit the jurisdictions of use.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="purpose" minOccurs="0" maxOccurs="1" type="markdown">
            <xs:annotation>
              <xs:documentation xml:lang="en">Explanation of why this DeviceDefinition is needed and why it has been designed as it has.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="copyright" minOccurs="0" maxOccurs="1" type="markdown">
            <xs:annotation>
              <xs:documentation xml:lang="en">A copyright statement relating to the DeviceDefinition and/or its contents. Copyright statements are notices of intellectual property ownership and can include restrictions on the use and publishing of the DeviceDefinition.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="copyrightLabel" minOccurs="0" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">A short string (&lt;50 characters), suitable for inclusion in a page footer that identifies the copyright holder, effective period, and optionally whether rights are restricted. (e.g. 'All rights reserved', 'Some rights reserved').</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="approvalDate" minOccurs="0" maxOccurs="1" type="date">
            <xs:annotation>
              <xs:documentation xml:lang="en">The date on which the asset content was approved by the publisher. Approval happens once when the content is officially approved for usage.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="lastReviewDate" minOccurs="0" maxOccurs="1" type="date">
            <xs:annotation>
              <xs:documentation xml:lang="en">The date on which the asset content was last reviewed. Review happens periodically after that, but doesn't change the original approval date.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="effectivePeriod" minOccurs="0" maxOccurs="1" type="Period">
            <xs:annotation>
              <xs:documentation xml:lang="en">The period during which the DeviceDefinition content was or is planned to be effective.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="partNumber" minOccurs="0" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">The part number or catalog number of the device.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="manufacturer" minOccurs="0" maxOccurs="1" type="Reference">
            <xs:annotation>
              <xs:documentation xml:lang="en">A name of the manufacturer  or legal representative e.g. labeler. Whether this is the actual manufacturer or the labeler or responsible depends on implementation and jurisdiction.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="modelNumber" minOccurs="0" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">The model number for the device for example as defined by the manufacturer or labeler, or other agency.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="udiDeviceIdentifier" type="DeviceDefinition.UdiDeviceIdentifier" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">The Device Identifier (DI) portion of the Unique Device Identifier (UDI) placed on a device label or package. Also known as UDI-DI. Note that the DeviceDefinition may include multiple UDI-DIs if it is sold in multiple jurisdictions.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="regulatoryIdentifier" type="DeviceDefinition.RegulatoryIdentifier" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">Identifier associated with the regulatory documentation (certificates, technical documentation, post-market surveillance documentation and reports) of a set of device models sharing the same intended purpose, risk class and essential design and manufacturing characteristics. One example is the Basic UDI-DI in Europe.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="deviceName" type="DeviceDefinition.DeviceName" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">The name or names of the device as given by the manufacturer.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="classification" type="DeviceDefinition.Classification" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">What kind of device or device system this is.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="conformsTo" type="DeviceDefinition.ConformsTo" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">Identifies the standards, specifications, or formal guidances for the capabilities supported by the device. The device may be certified as conformant to these specifications e.g., communication, performance, process, measurement, or specialization standards.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="hasPart" type="DeviceDefinition.HasPart" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">A device that is part (for example a component) of the present device.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="packaging" type="DeviceDefinition.Packaging" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">Information about the packaging of the device, i.e. how the device is packaged.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="deviceVersion" type="DeviceDefinition.DeviceVersion" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">The version of the device or software.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="safety" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Safety characteristics of the device.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="shelfLifeStorage" minOccurs="0" maxOccurs="unbounded" type="ProductShelfLife">
            <xs:annotation>
              <xs:documentation xml:lang="en">Shelf Life and storage information.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="outputLanguage" minOccurs="0" maxOccurs="unbounded" type="code">
            <xs:annotation>
              <xs:documentation xml:lang="en">Language code for the human-readable text strings produced by the device (all supported).</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="property" type="DeviceDefinition.Property" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">Static or essentially fixed characteristics or features of this kind of device that are otherwise not captured in more specific attributes, e.g., time or timing attributes, resolution, accuracy, and physical attributes.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="link" type="DeviceDefinition.Link" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="note" minOccurs="0" maxOccurs="unbounded" type="Annotation">
            <xs:annotation>
              <xs:documentation xml:lang="en">Descriptive information, usage information or implantation information that is not captured in an existing element.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="material" type="DeviceDefinition.Material" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">A substance used to create the material(s) of which the device is made.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="productionIdentifierInUDI" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Indicates the production identifier(s) that are expected to appear in the UDI carrier on the device label.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="guideline" type="DeviceDefinition.Guideline" minOccurs="0" maxOccurs="1">
            <xs:annotation>
              <xs:documentation xml:lang="en">Information aimed at providing directions for the usage of this model of device.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="correctiveAction" type="DeviceDefinition.CorrectiveAction" minOccurs="0" maxOccurs="1">
            <xs:annotation>
              <xs:documentation xml:lang="en">Tracking of latest field safety corrective action.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="chargeItem" type="DeviceDefinition.ChargeItem" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">Billing code or reference associated with the device.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="DeviceDefinition.UdiDeviceIdentifier">
    <xs:annotation>
      <xs:documentation xml:lang="en">The definition of a kind of device or device component. Typically, this definition corresponds to a device model although it may be a broader category of device.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="deviceIdentifier" minOccurs="1" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="issuer" minOccurs="1" maxOccurs="1" type="uri">
            <xs:annotation>
              <xs:documentation xml:lang="en">The organization that assigns the identifier algorithm.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="jurisdiction" minOccurs="1" maxOccurs="1" type="uri">
            <xs:annotation>
              <xs:documentation xml:lang="en">The jurisdiction to which the deviceIdentifier applies.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="marketDistribution" type="DeviceDefinition.MarketDistribution" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">Indicates where and when the device is available on the market.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="deviceIdentifierSystem" minOccurs="0" maxOccurs="1" type="uri">
            <xs:annotation>
              <xs:documentation xml:lang="en">Establishes the namespace for the issuing agency's system (e.g, GS1's GTIN, ICCBBA's ISBT-128) used to create the device identifier.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="DeviceDefinition.MarketDistribution">
    <xs:annotation>
      <xs:documentation xml:lang="en">The definition of a kind of device or device component. Typically, this definition corresponds to a device model although it may be a broader category of device.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="marketPeriod" minOccurs="1" maxOccurs="1" type="Period">
            <xs:annotation>
              <xs:documentation xml:lang="en">Begin and end dates for the commercial distribution of the device.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="subJurisdiction" minOccurs="1" maxOccurs="1" type="uri">
            <xs:annotation>
              <xs:documentation xml:lang="en">National state or territory to which the marketDistribution recers, typically where the device is commercialized.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="DeviceDefinition.RegulatoryIdentifier">
    <xs:annotation>
      <xs:documentation xml:lang="en">The definition of a kind of device or device component. Typically, this definition corresponds to a device model although it may be a broader category of device.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="type" minOccurs="1" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">The type of identifier itself.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="identifier" minOccurs="1" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">The identifier used in the associated regulatory context.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="issuer" minOccurs="1" maxOccurs="1" type="uri">
            <xs:annotation>
              <xs:documentation xml:lang="en">The organization that issued this identifier.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="jurisdiction" minOccurs="1" maxOccurs="1" type="uri">
            <xs:annotation>
              <xs:documentation xml:lang="en">The applicable jurisdiction overseeing the enforcement of the Identifier.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="identifierSystem" minOccurs="0" maxOccurs="1" type="uri">
            <xs:annotation>
              <xs:documentation xml:lang="en">Establishes the namespace for the issuing agency's system (e.g, GS1's GTIN, ICCBBA's ISBT-128) used to create the identifier.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="DeviceDefinition.DeviceName">
    <xs:annotation>
      <xs:documentation xml:lang="en">The definition of a kind of device or device component. Typically, this definition corresponds to a device model although it may be a broader category of device.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="name" minOccurs="1" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">A human-friendly name that is used to refer to the device - depending on the type, it can be the brand name, the common name or alias, or other.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="type" minOccurs="1" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">The type of deviceName.
RegisteredName | UserFriendlyName | PatientReportedName.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="DeviceDefinition.Classification">
    <xs:annotation>
      <xs:documentation xml:lang="en">The definition of a kind of device or device component. Typically, this definition corresponds to a device model although it may be a broader category of device.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="type" minOccurs="1" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">A classification or risk class of the device model.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="justification" minOccurs="0" maxOccurs="unbounded" type="RelatedArtifact">
            <xs:annotation>
              <xs:documentation xml:lang="en">Further information qualifying this classification of the device model.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="DeviceDefinition.ConformsTo">
    <xs:annotation>
      <xs:documentation xml:lang="en">The definition of a kind of device or device component. Typically, this definition corresponds to a device model although it may be a broader category of device.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="category" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Describes the type of the standard, specification, or formal guidance.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="specification" minOccurs="1" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Code that identifies the specific standard, specification, protocol, formal guidance, regulation, legislation, or certification scheme to which the device adheres.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="version" minOccurs="0" maxOccurs="unbounded" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">Identifies the specific form or variant of the standard, specification, or formal guidance. This may be a 'version number', release, document edition, publication year, or other label.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="source" minOccurs="0" maxOccurs="unbounded" type="RelatedArtifact">
            <xs:annotation>
              <xs:documentation xml:lang="en">Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="DeviceDefinition.HasPart">
    <xs:annotation>
      <xs:documentation xml:lang="en">The definition of a kind of device or device component. Typically, this definition corresponds to a device model although it may be a broader category of device.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:choice minOccurs="1" maxOccurs="1" >
            <xs:annotation>
              <xs:documentation xml:lang="en">The device that is part of the current device.</xs:documentation>
            </xs:annotation>
            <xs:element name="definitionCanonical" type="canonical"/>
            <xs:element name="definitionCodeableConcept" type="CodeableConcept"/>
          </xs:choice>
          <xs:element name="count" minOccurs="0" maxOccurs="1" type="integer">
            <xs:annotation>
              <xs:documentation xml:lang="en">Number of instances of the component device in the current device.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="DeviceDefinition.Packaging">
    <xs:annotation>
      <xs:documentation xml:lang="en">The definition of a kind of device or device component. Typically, this definition corresponds to a device model although it may be a broader category of device.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="identifier" minOccurs="0" maxOccurs="1" type="Identifier">
            <xs:annotation>
              <xs:documentation xml:lang="en">The business identifier of the packaged medication.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="type" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">A code that defines the specific type of packaging.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="count" minOccurs="0" maxOccurs="1" type="integer">
            <xs:annotation>
              <xs:documentation xml:lang="en">The number of items contained in the package (devices or sub-packages).</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="distributor" type="DeviceDefinition.Distributor" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">An organization that distributes the packaged device.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="udiDeviceIdentifier" type="DeviceDefinition.UdiDeviceIdentifier" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">Unique Device Identifier (UDI) Barcode string on the packaging.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="packaging" type="DeviceDefinition.Packaging" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">Allows packages within packages.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="DeviceDefinition.Distributor">
    <xs:annotation>
      <xs:documentation xml:lang="en">The definition of a kind of device or device component. Typically, this definition corresponds to a device model although it may be a broader category of device.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="name" minOccurs="0" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">Distributor's human-readable name.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="organizationReference" minOccurs="0" maxOccurs="unbounded" type="Reference">
            <xs:annotation>
              <xs:documentation xml:lang="en">Distributor as an Organization resource.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="DeviceDefinition.DeviceVersion">
    <xs:annotation>
      <xs:documentation xml:lang="en">The definition of a kind of device or device component. Typically, this definition corresponds to a device model although it may be a broader category of device.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="type" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">The type of the device version, e.g. manufacturer, approved, internal.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="component" minOccurs="0" maxOccurs="1" type="Identifier">
            <xs:annotation>
              <xs:documentation xml:lang="en">The hardware or software module of the device to which the version applies.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="value" minOccurs="1" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">The version text.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="DeviceDefinition.Property">
    <xs:annotation>
      <xs:documentation xml:lang="en">The definition of a kind of device or device component. Typically, this definition corresponds to a device model although it may be a broader category of device.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="type" minOccurs="1" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Code that specifies the property such as a resolution or color being represented.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:choice minOccurs="1" maxOccurs="1" >
            <xs:annotation>
              <xs:documentation xml:lang="en">The value of the property specified by the associated property.type code.</xs:documentation>
            </xs:annotation>
            <xs:element name="valueQuantity" type="Quantity"/>
            <xs:element name="valueCodeableConcept" type="CodeableConcept"/>
            <xs:element name="valueString" type="string"/>
            <xs:element name="valueBoolean" type="boolean"/>
            <xs:element name="valueInteger" type="integer"/>
            <xs:element name="valueRange" type="Range"/>
            <xs:element name="valueAttachment" type="Attachment"/>
          </xs:choice>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="DeviceDefinition.Link">
    <xs:annotation>
      <xs:documentation xml:lang="en">The definition of a kind of device or device component. Typically, this definition corresponds to a device model although it may be a broader category of device.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="relation" minOccurs="1" maxOccurs="1" type="Coding">
            <xs:annotation>
              <xs:documentation xml:lang="en">The type indicates the relationship of the related device to the device instance.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:choice minOccurs="1" maxOccurs="1" >
            <xs:annotation>
              <xs:documentation xml:lang="en">A reference to the linked device.</xs:documentation>
            </xs:annotation>
            <xs:element name="relatedDeviceCanonical" type="canonical"/>
            <xs:element name="relatedDeviceCodeableConcept" type="CodeableConcept"/>
          </xs:choice>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="DeviceDefinition.Material">
    <xs:annotation>
      <xs:documentation xml:lang="en">The definition of a kind of device or device component. Typically, this definition corresponds to a device model although it may be a broader category of device.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="substance" minOccurs="1" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">A substance that the device contains, may contain, or is made of - for example latex - to be used to determine patient compatibility. This is not intended to represent the composition of the device, only the clinically relevant materials.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="alternate" minOccurs="0" maxOccurs="1" type="boolean">
            <xs:annotation>
              <xs:documentation xml:lang="en">Indicates an alternative material of the device.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="allergenicIndicator" minOccurs="0" maxOccurs="1" type="boolean">
            <xs:annotation>
              <xs:documentation xml:lang="en">Whether the substance is a known or suspected allergen.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="DeviceDefinition.Guideline">
    <xs:annotation>
      <xs:documentation xml:lang="en">The definition of a kind of device or device component. Typically, this definition corresponds to a device model although it may be a broader category of device.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="useContext" minOccurs="0" maxOccurs="unbounded" type="UsageContext">
            <xs:annotation>
              <xs:documentation xml:lang="en">The circumstances that form the setting for using the device.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="usageInstruction" minOccurs="0" maxOccurs="1" type="markdown">
            <xs:annotation>
              <xs:documentation xml:lang="en">Detailed written and visual directions for the user on how to use the device.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="relatedArtifact" minOccurs="0" maxOccurs="unbounded" type="RelatedArtifact">
            <xs:annotation>
              <xs:documentation xml:lang="en">A source of information or reference for this guideline.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="indication" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">A clinical condition for which the device was designed to be used.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="contraindication" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">A specific situation when a device should not be used because it may cause harm.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="warning" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Specific hazard alert information that a user needs to know before using the device.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="intendedUse" minOccurs="0" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">A description of the general purpose or medical use of the device or its function.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="DeviceDefinition.CorrectiveAction">
    <xs:annotation>
      <xs:documentation xml:lang="en">The definition of a kind of device or device component. Typically, this definition corresponds to a device model although it may be a broader category of device.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="recall" minOccurs="1" maxOccurs="1" type="boolean">
            <xs:annotation>
              <xs:documentation xml:lang="en">Whether the last corrective action known for this device was a recall.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="scope" minOccurs="0" maxOccurs="1" type="DeviceCorrectiveActionScope">
            <xs:annotation>
              <xs:documentation xml:lang="en">The scope of the corrective action - whether the action targeted all units of a given device model, or only a specific set of batches identified by lot numbers, or individually identified devices identified by the serial name.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="period" minOccurs="1" maxOccurs="1" type="Period">
            <xs:annotation>
              <xs:documentation xml:lang="en">Start and end dates of the  corrective action.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="DeviceDefinition.ChargeItem">
    <xs:annotation>
      <xs:documentation xml:lang="en">The definition of a kind of device or device component. Typically, this definition corresponds to a device model although it may be a broader category of device.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="chargeItemCode" minOccurs="1" maxOccurs="1" type="CodeableReference">
            <xs:annotation>
              <xs:documentation xml:lang="en">The code or reference for the charge item.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="count" minOccurs="1" maxOccurs="1" type="Quantity">
            <xs:annotation>
              <xs:documentation xml:lang="en">Coefficient applicable to the billing code.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="effectivePeriod" minOccurs="0" maxOccurs="1" type="Period">
            <xs:annotation>
              <xs:documentation xml:lang="en">A specific time period in which this charge item applies.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="useContext" minOccurs="0" maxOccurs="unbounded" type="UsageContext">
            <xs:annotation>
              <xs:documentation xml:lang="en">The context to which this charge item applies.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:simpleType name="DeviceCorrectiveActionScopeEnum">
    <xs:restriction base="code-primitive">
      <xs:enumeration value="model">
        <xs:annotation>
          <xs:documentation xml:lang="en">Model</xs:documentation>
        </xs:annotation>
      </xs:enumeration>
      <xs:enumeration value="lot-numbers">
        <xs:annotation>
          <xs:documentation xml:lang="en">Lot Numbers</xs:documentation>
        </xs:annotation>
      </xs:enumeration>
      <xs:enumeration value="serial-numbers">
        <xs:annotation>
          <xs:documentation xml:lang="en">Serial Numbers</xs:documentation>
        </xs:annotation>
      </xs:enumeration>
    </xs:restriction>
  </xs:simpleType>
  <xs:complexType name="DeviceCorrectiveActionScope">
    <xs:annotation>
      <xs:documentation xml:lang="en"></xs:documentation>
      <xs:documentation xml:lang="en">If the element is present, it must have either a @value, an @id, or extensions</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="Element">
        <xs:attribute name="value" type="DeviceCorrectiveActionScopeEnum" use="optional"/>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
</xs:schema>
