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<?xml version="1.0" encoding="UTF-8"?>
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Generated on Thu, Dec 27, 2018 22:37+1100 for FHIR v4.0.0
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
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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">
<xs:include schemaLocation="fhir-base.xsd"/>
<xs:element name="Device" type="Device">
<xs:annotation>
<xs:documentation xml:lang="en">A type of 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 type of 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="Reference">
<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) 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>
</xs:annotation>
</xs:element>
<xs:element name="status" minOccurs="0" maxOccurs="1" type="FHIRDeviceStatus">
<xs:annotation>
<xs:documentation xml:lang="en">Status of the Device availability.</xs:documentation>
</xs:annotation>
</xs:element>
<xs:element name="statusReason" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
<xs:annotation>
<xs:documentation xml:lang="en">Reason for the dtatus of the Device availability.</xs:documentation>
</xs:annotation>
</xs:element>
<xs:element name="distinctIdentifier" minOccurs="0" maxOccurs="1" type="string">
<xs:annotation>
<xs:documentation xml:lang="en">The distinct identification string as required by regulation for a human cell, tissue, or cellular and tissue-based product.</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.</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="deviceName" type="Device.DeviceName" 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 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 of the device.</xs:documentation>
</xs:annotation>
</xs:element>
<xs:element name="type" minOccurs="0" maxOccurs="1" type="CodeableConcept">
<xs:annotation>
<xs:documentation xml:lang="en">The kind or type of device.</xs:documentation>
</xs:annotation>
</xs:element>
<xs:element name="specialization" type="Device.Specialization" minOccurs="0" maxOccurs="unbounded">
<xs:annotation>
<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>
</xs:annotation>
</xs:element>
<xs:element name="version" type="Device.Version" 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="property" type="Device.Property" minOccurs="0" maxOccurs="unbounded">
<xs:annotation>
<xs:documentation xml:lang="en">The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties.</xs:documentation>
</xs:annotation>
</xs:element>
<xs:element name="patient" minOccurs="0" maxOccurs="1" type="Reference">
<xs:annotation>
<xs:documentation xml:lang="en">Patient information, If the device is affixed to a person.</xs:documentation>
</xs:annotation>
</xs:element>
<xs:element name="owner" minOccurs="0" maxOccurs="1" type="Reference">
<xs:annotation>
<xs:documentation xml:lang="en">An organization that is responsible for the provision and ongoing maintenance of the device.</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="url" minOccurs="0" maxOccurs="1" type="uri">
<xs:annotation>
<xs:documentation xml:lang="en">A network address on which the device may be contacted directly.</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 parent device.</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 type of 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="0" maxOccurs="1" type="string">
<xs:annotation>
<xs:documentation xml:lang="en">The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.</xs:documentation>
</xs:annotation>
</xs:element>
<xs:element name="issuer" minOccurs="0" 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-dI,
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.</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/fda-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 of the barcode string as printed on the packaging of the device - e.g., a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats *SHALL* be base64 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 of the barcode string 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.DeviceName">
<xs:annotation>
<xs:documentation xml:lang="en">A type of 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="name" minOccurs="1" maxOccurs="1" type="string">
<xs:annotation>
<xs:documentation xml:lang="en">The name of the device.</xs:documentation>
</xs:annotation>
</xs:element>
<xs:element name="type" minOccurs="1" maxOccurs="1" type="DeviceNameType">
<xs:annotation>
<xs:documentation xml:lang="en">The type of deviceName.
UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName.</xs:documentation>
</xs:annotation>
</xs:element>
</xs:sequence>
</xs:extension>
</xs:complexContent>
</xs:complexType>
<xs:complexType name="Device.Specialization">
<xs:annotation>
<xs:documentation xml:lang="en">A type of 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="systemType" minOccurs="1" maxOccurs="1" type="CodeableConcept">
<xs:annotation>
<xs:documentation xml:lang="en">The standard that is used to operate and communicate.</xs:documentation>
</xs:annotation>
</xs:element>
<xs:element name="version" minOccurs="0" maxOccurs="1" type="string">
<xs:annotation>
<xs:documentation xml:lang="en">The version of the standard that is used to operate and communicate.</xs:documentation>
</xs:annotation>
</xs:element>
</xs:sequence>
</xs:extension>
</xs:complexContent>
</xs:complexType>
<xs:complexType name="Device.Version">
<xs:annotation>
<xs:documentation xml:lang="en">A type of 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.</xs:documentation>
</xs:annotation>
</xs:element>
<xs:element name="component" minOccurs="0" maxOccurs="1" type="Identifier">
<xs:annotation>
<xs:documentation xml:lang="en">A single component of the device version.</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.Property">
<xs:annotation>
<xs:documentation xml:lang="en">A type of 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 DeviceDefinitionPropetyCode (Extensible).</xs:documentation>
</xs:annotation>
</xs:element>
<xs:element name="valueQuantity" minOccurs="0" maxOccurs="unbounded" type="Quantity">
<xs:annotation>
<xs:documentation xml:lang="en">Property value as a quantity.</xs:documentation>
</xs:annotation>
</xs:element>
<xs:element name="valueCode" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
<xs:annotation>
<xs:documentation xml:lang="en">Property value as a code, e.g., NTP4 (synced to NTP).</xs:documentation>
</xs:annotation>
</xs:element>
</xs:sequence>
</xs:extension>
</xs:complexContent>
</xs:complexType>
<xs:simpleType name="FHIRDeviceStatus-list">
<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">The availability status of the 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="Element">
<xs:attribute name="value" type="FHIRDeviceStatus-list" use="optional"/>
</xs:extension>
</xs:complexContent>
</xs:complexType>
<xs:simpleType name="DeviceNameType-list">
<xs:restriction base="code-primitive">
<xs:enumeration value="udi-label-name">
<xs:annotation>
<xs:documentation xml:lang="en">UDI Label name</xs:documentation>
</xs:annotation>
</xs:enumeration>
<xs:enumeration value="user-friendly-name">
<xs:annotation>
<xs:documentation xml:lang="en">User Friendly name</xs:documentation>
</xs:annotation>
</xs:enumeration>
<xs:enumeration value="patient-reported-name">
<xs:annotation>
<xs:documentation xml:lang="en">Patient Reported name</xs:documentation>
</xs:annotation>
</xs:enumeration>
<xs:enumeration value="manufacturer-name">
<xs:annotation>
<xs:documentation xml:lang="en">Manufacturer name</xs:documentation>
</xs:annotation>
</xs:enumeration>
<xs:enumeration value="model-name">
<xs:annotation>
<xs:documentation xml:lang="en">Model name</xs:documentation>
</xs:annotation>
</xs:enumeration>
<xs:enumeration value="other">
<xs:annotation>
<xs:documentation xml:lang="en">other</xs:documentation>
</xs:annotation>
</xs:enumeration>
</xs:restriction>
</xs:simpleType>
<xs:complexType name="DeviceNameType">
<xs:annotation>
<xs:documentation xml:lang="en">The type of name the device is referred by.</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="DeviceNameType-list" use="optional"/>
</xs:extension>
</xs:complexContent>
</xs:complexType>
<xs:simpleType name="UDIEntryType-list">
<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="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">Codes to identify how UDI data was entered.</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="UDIEntryType-list" use="optional"/>
</xs:extension>
</xs:complexContent>
</xs:complexType>
</xs:schema>