<?xml version="1.0" encoding="UTF-8"?>
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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 
  PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, 
  WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) 
  ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE 
  POSSIBILITY OF SUCH DAMAGE.
  

  Generated on Thu, Apr 9, 2026 17:12+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="Device" type="Device">
    <xs:annotation>
      <xs:documentation xml:lang="en">A manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device.</xs:documentation>
    </xs:annotation>
  </xs:element>
  <xs:complexType name="Device">
    <xs:annotation>
      <xs:documentation xml:lang="en">A manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical 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="DomainResource">
        <xs:sequence>
          <xs:element name="identifier" minOccurs="0" maxOccurs="unbounded" type="Identifier">
            <xs:annotation>
              <xs:documentation xml:lang="en">Unique instance identifiers assigned to a device by manufacturers other organizations or owners.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="definition" minOccurs="0" maxOccurs="1" type="canonical">
            <xs:annotation>
              <xs:documentation xml:lang="en">The reference to the definition for the device.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="udiCarrier" type="Device.UdiCarrier" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">Unique Device Identifier (UDI) placed on a device label or package. Note that the Device may include multiple UDIs if it is sold in multiple jurisdictions.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="status" minOccurs="0" maxOccurs="1" type="FHIRDeviceStatus">
            <xs:annotation>
              <xs:documentation xml:lang="en">The Device record status. This is not the status of the device like availability.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="availabilityStatus" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">The availability of the device.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="biologicalSourceEvent" minOccurs="0" maxOccurs="1" type="Identifier">
            <xs:annotation>
              <xs:documentation xml:lang="en">A production identifier of the donor, donation, or pooling event associated with the biological material incorporated into the device.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="manufacturer" minOccurs="0" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">A name of the manufacturer or entity legally responsible for the device.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="manufactureDate" minOccurs="0" maxOccurs="1" type="dateTime">
            <xs:annotation>
              <xs:documentation xml:lang="en">The date and time when the device was manufactured.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="expirationDate" minOccurs="0" maxOccurs="1" type="dateTime">
            <xs:annotation>
              <xs:documentation xml:lang="en">The date and time beyond which this device is no longer valid or should not be used (if applicable).</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="lotNumber" minOccurs="0" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">Lot number assigned by the manufacturer.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="serialNumber" minOccurs="0" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">The serial number assigned by the organization when the device was manufactured.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="name" type="Device.Name" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">This represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device.  This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="modelNumber" minOccurs="0" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">The manufacturer's model number for the device.</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="category" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Devices may be associated with one or more categories.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="type" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">The kind or type of device. A device instance may have more than one type - in which case those are the types that apply to the specific instance of the device.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="deviceVersion" type="Device.DeviceVersion" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">The actual design of the device or software version running on the device.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="conformsTo" type="Device.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="property" type="Device.Property" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">Static or essentially fixed characteristics or features of the device (e.g., time or timing attributes, resolution, accuracy, intended use or instructions for use, and physical attributes) that are not otherwise captured in more specific attributes.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="additive" type="Device.Additive" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">Material added to a container device (typically used in specimen collection or initial processing).  The material may be added by the device manufacturer or by a different party subsequent to manufacturing.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="contact" minOccurs="0" maxOccurs="unbounded" type="ContactPoint">
            <xs:annotation>
              <xs:documentation xml:lang="en">Contact details for an organization or a particular human that is responsible for the device.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="location" minOccurs="0" maxOccurs="1" type="Reference">
            <xs:annotation>
              <xs:documentation xml:lang="en">The place where the device can be found.</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="safety" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Provides additional safety characteristics about a medical device.  For example devices containing latex.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="parent" minOccurs="0" maxOccurs="1" type="Reference">
            <xs:annotation>
              <xs:documentation xml:lang="en">The higher level or encompassing device that this device is a logical part of.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="Device.UdiCarrier">
    <xs:annotation>
      <xs:documentation xml:lang="en">A manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical 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 device identifier (UDI-DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device. The UDI-DI portion is placed on a device label or package. 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="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:element name="issuer" minOccurs="1" maxOccurs="1" type="uri">
            <xs:annotation>
              <xs:documentation xml:lang="en">Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include: 
1) GS1: http://hl7.org/fhir/NamingSystem/gs1-di, 
2) HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-diI, 
3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, 
4) ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di # Informationsstelle für Arzneispezialitäten (IFA GmbH) (EU only): http://hl7.org/fhir/NamingSystem/ifa-gmbh-di.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="jurisdiction" minOccurs="0" maxOccurs="1" type="uri">
            <xs:annotation>
              <xs:documentation xml:lang="en">The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/us-fda-udi or in the European Union by the European Commission http://hl7.org/fhir/NamingSystem/eu-ec-udi.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="carrierAIDC" minOccurs="0" maxOccurs="1" type="base64Binary">
            <xs:annotation>
              <xs:documentation xml:lang="en">The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation as printed on the packaging of the device - e.g., a barcode , 2D Matrix, or RFID. Some AIDC representations contain non-printable characters and cannot be represented in a string format.  For this reason, AIDC format SHALL be base64Binary encoded.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="carrierHRF" minOccurs="0" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">The full UDI carrier as the human readable form (HRF) representation as printed on the packaging of the device.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="entryType" minOccurs="0" maxOccurs="1" type="UDIEntryType">
            <xs:annotation>
              <xs:documentation xml:lang="en">A coded entry to indicate how the data was entered.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="Device.Name">
    <xs:annotation>
      <xs:documentation xml:lang="en">A manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="value" minOccurs="1" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">The actual name that identifies the device.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="type" minOccurs="1" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Indicates the kind of name. RegisteredName | UserFriendlyName | PatientReportedName.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="display" minOccurs="0" maxOccurs="1" type="boolean">
            <xs:annotation>
              <xs:documentation xml:lang="en">Indicates the default or preferred name to be displayed.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="Device.DeviceVersion">
    <xs:annotation>
      <xs:documentation xml:lang="en">A manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical 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="installDate" minOccurs="0" maxOccurs="1" type="dateTime">
            <xs:annotation>
              <xs:documentation xml:lang="en">The date the version was installed on the device.</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="Device.ConformsTo">
    <xs:annotation>
      <xs:documentation xml:lang="en">A manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical 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="1" 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:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="Device.Property">
    <xs:annotation>
      <xs:documentation xml:lang="en">A manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical 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 resolution, color, size, 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="Device.Additive">
    <xs:annotation>
      <xs:documentation xml:lang="en">A manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="type" minOccurs="1" maxOccurs="1" type="CodeableReference">
            <xs:annotation>
              <xs:documentation xml:lang="en">The type of the substance added to the container.  This is represented as a concept from a code system or described in a Substance resource.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="quantity" minOccurs="0" maxOccurs="1" type="Quantity">
            <xs:annotation>
              <xs:documentation xml:lang="en">The quantity of the additive substance in the container; may be volume, dimensions, or other appropriate measurements, depending on the container and additive substance type.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:simpleType name="FHIRDeviceStatusEnum">
    <xs:restriction base="code-primitive">
      <xs:enumeration value="active">
        <xs:annotation>
          <xs:documentation xml:lang="en">Active</xs:documentation>
        </xs:annotation>
      </xs:enumeration>
      <xs:enumeration value="inactive">
        <xs:annotation>
          <xs:documentation xml:lang="en">Inactive</xs:documentation>
        </xs:annotation>
      </xs:enumeration>
      <xs:enumeration value="entered-in-error">
        <xs:annotation>
          <xs:documentation xml:lang="en">Entered in Error</xs:documentation>
        </xs:annotation>
      </xs:enumeration>
      <xs:enumeration value="unknown">
        <xs:annotation>
          <xs:documentation xml:lang="en">Unknown</xs:documentation>
        </xs:annotation>
      </xs:enumeration>
    </xs:restriction>
  </xs:simpleType>
  <xs:complexType name="FHIRDeviceStatus">
    <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="FHIRDeviceStatusEnum" use="optional"/>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:simpleType name="UDIEntryTypeEnum">
    <xs:restriction base="code-primitive">
      <xs:enumeration value="barcode">
        <xs:annotation>
          <xs:documentation xml:lang="en">Barcode</xs:documentation>
        </xs:annotation>
      </xs:enumeration>
      <xs:enumeration value="rfid">
        <xs:annotation>
          <xs:documentation xml:lang="en">RFID</xs:documentation>
        </xs:annotation>
      </xs:enumeration>
      <xs:enumeration value="manual">
        <xs:annotation>
          <xs:documentation xml:lang="en">Manual</xs:documentation>
        </xs:annotation>
      </xs:enumeration>
      <xs:enumeration value="card">
        <xs:annotation>
          <xs:documentation xml:lang="en">Card</xs:documentation>
        </xs:annotation>
      </xs:enumeration>
      <xs:enumeration value="self-reported">
        <xs:annotation>
          <xs:documentation xml:lang="en">Self Reported</xs:documentation>
        </xs:annotation>
      </xs:enumeration>
      <xs:enumeration value="electronic-transmission">
        <xs:annotation>
          <xs:documentation xml:lang="en">Electronic Transmission</xs:documentation>
        </xs:annotation>
      </xs:enumeration>
      <xs:enumeration value="unknown">
        <xs:annotation>
          <xs:documentation xml:lang="en">Unknown</xs:documentation>
        </xs:annotation>
      </xs:enumeration>
    </xs:restriction>
  </xs:simpleType>
  <xs:complexType name="UDIEntryType">
    <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="UDIEntryTypeEnum" use="optional"/>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
</xs:schema>
