ITU-T H 845 14-2015 Conformance of ITU-T H 810 personal health devices PAN LAN TAN interface Part 5N International normalized ratio Agent (Study Group 16)《ITU-T H 810的个人健康设备的一致性 PA.pdf

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1、 I n t e r n a t i o n a l T e l e c o m m u n i c a t i o n U n i o n ITU-T H.845.14 TELECOMMUNICATION STANDARDIZATION SECTOR OF ITU (01/2015) SERIES H: AUDIOVISUAL AND MULTIMEDIA SYSTEMS E-health multimedia services and applications Interoperability compliance testing of personal health systems (H

2、RN, PAN, LAN and WAN) Conformance of ITU-T H.810 personal health devices: PAN/LAN/TAN interface Part 5N: International normalized ratio: Agent Recommendation ITU-T H.845.14 ITU-T H-SERIES RECOMMENDATIONS AUDIOVISUAL AND MULTIMEDIA SYSTEMS CHARACTERISTICS OF VISUAL TELEPHONE SYSTEMS H.100H.199 INFRAS

3、TRUCTURE OF AUDIOVISUAL SERVICES General H.200H.219 Transmission multiplexing and synchronization H.220H.229 Systems aspects H.230H.239 Communication procedures H.240H.259 Coding of moving video H.260H.279 Related systems aspects H.280H.299 Systems and terminal equipment for audiovisual services H.3

4、00H.349 Directory services architecture for audiovisual and multimedia services H.350H.359 Quality of service architecture for audiovisual and multimedia services H.360H.369 Telepresence H.420H.429 Supplementary services for multimedia H.450H.499 MOBILITY AND COLLABORATION PROCEDURES Overview of Mob

5、ility and Collaboration, definitions, protocols and procedures H.500H.509 Mobility for H-Series multimedia systems and services H.510H.519 Mobile multimedia collaboration applications and services H.520H.529 Security for mobile multimedia systems and services H.530H.539 Security for mobile multimedi

6、a collaboration applications and services H.540H.549 Mobility interworking procedures H.550H.559 Mobile multimedia collaboration inter-working procedures H.560H.569 BROADBAND, TRIPLE-PLAY AND ADVANCED MULTIMEDIA SERVICES Broadband multimedia services over VDSL H.610H.619 Advanced multimedia services

7、 and applications H.620H.629 Ubiquitous sensor network applications and Internet of Things H.640H.649 IPTV MULTIMEDIA SERVICES AND APPLICATIONS FOR IPTV General aspects H.700H.719 IPTV terminal devices H.720H.729 IPTV middleware H.730H.739 IPTV application event handling H.740H.749 IPTV metadata H.7

8、50H.759 IPTV multimedia application frameworks H.760H.769 IPTV service discovery up to consumption H.770H.779 Digital Signage H.780H.789 E-HEALTH MULTIMEDIA SERVICES AND APPLICATIONS Interoperability compliance testing of personal health systems (HRN, PAN, LAN, TAN and WAN) H.820H.859 Multimedia e-h

9、ealth data exchange services H.860H.869 For further details, please refer to the list of ITU-T Recommendations. Rec. ITU-T H.845.14 (01/2015) i Recommendation ITU-T H.845.14 Conformance of ITU-T H.810 personal health devices: PAN/LAN/TAN interface Part 5N: International normalized ratio: Agent Summa

10、ry Recommendation ITU-T H.845.14 is a transposition of Continua Test Tool DG2013, Test Suite Structure Part 5N: Device Specializations. Agent (International Normalized Ratio -INR-) (Version 1.0, 2014-01-24), that was developed by the Continua Health Alliance. Versions of this specification existed b

11、efore transposition and are indicated in Table 1. This Recommendation includes an electronic attachment with the protocol implementation conformance statements (PICS) and the protocol implementation extra information for testing (PIXIT) required for the implementation of Annex A. History Edition Rec

12、ommendation Approval Study Group Unique ID* 1.0 ITU-T H.845.14 2015-01-13 16 11.1002/1000/12274 _ * To access the Recommendation, type the URL http:/handle.itu.int/ in the address field of your web browser, followed by the Recommendations unique ID. For example, http:/handle.itu.int/11.1002/1000/118

13、30-en. ii Rec. ITU-T H.845.14 (01/2015) FOREWORD The International Telecommunication Union (ITU) is the United Nations specialized agency in the field of telecommunications, information and communication technologies (ICTs). The ITU Telecommunication Standardization Sector (ITU-T) is a permanent org

14、an of ITU. ITU-T is responsible for studying technical, operating and tariff questions and issuing Recommendations on them with a view to standardizing telecommunications on a worldwide basis. The World Telecommunication Standardization Assembly (WTSA), which meets every four years, establishes the

15、topics for study by the ITU-T study groups which, in turn, produce Recommendations on these topics. The approval of ITU-T Recommendations is covered by the procedure laid down in WTSA Resolution 1. In some areas of information technology which fall within ITU-Ts purview, the necessary standards are

16、prepared on a collaborative basis with ISO and IEC. NOTE In this Recommendation, the expression “Administration“ is used for conciseness to indicate both a telecommunication administration and a recognized operating agency. Compliance with this Recommendation is voluntary. However, the Recommendatio

17、n may contain certain mandatory provisions (to ensure, e.g., interoperability or applicability) and compliance with the Recommendation is achieved when all of these mandatory provisions are met. The words “shall“ or some other obligatory language such as “must“ and the negative equivalents are used

18、to express requirements. The use of such words does not suggest that compliance with the Recommendation is required of any party. INTELLECTUAL PROPERTY RIGHTSITU draws attention to the possibility that the practice or implementation of this Recommendation may involve the use of a claimed Intellectua

19、l Property Right. ITU takes no position concerning the evidence, validity or applicability of claimed Intellectual Property Rights, whether asserted by ITU members or others outside of the Recommendation development process. As of the date of approval of this Recommendation, ITU had not received not

20、ice of intellectual property, protected by patents, which may be required to implement this Recommendation. However, implementers are cautioned that this may not represent the latest information and are therefore strongly urged to consult the TSB patent database at http:/www.itu.int/ITU-T/ipr/. ITU

21、2015 All rights reserved. No part of this publication may be reproduced, by any means whatsoever, without the prior written permission of ITU. Rec. ITU-T H.845.14 (01/2015) iii Table of Contents Page 1 Scope . 1 2 References . 2 3 Definitions 2 3.1 Terms defined elsewhere 2 3.2 Terms defined in this

22、 Recommendation . 2 4 Abbreviations and acronyms 2 5 Conventions 3 6 Test suite structure (TSS) . 4 7 Electronic attachment . 6 Annex A Test purposes (TPs) . 7 A.1 TP definition conventions . 7 A.2 Subgroup 1.3.14 International normalized ratio (INR) . 8 Bibliography. 46 Electronic attachment: Proto

23、col implementation conformance statements (PICS) and protocol implementation extra information for testing (PIXIT) required for the implementation of Annex A. iv Rec. ITU-T H.845.14 (01/2015) Introduction This Recommendation is a transposition of Continua Test Tool DG2013, Test Suite Structure Part

24、5N: Device Specializations. Agent (International Normalized Ratio -INR-) (Version 1.0, 2014-01-24), that was developed by the Continua Health Alliance. Versions of this specification existed before transposition and these can be found in the table below. Version Date Revision history 1.0 2014-01-24

25、New document. Initial release for Test Tool DG2013. Rec. ITU-T H.845.14 (01/2015) 1 Recommendation ITU-T H.845.14 Conformance of ITU-T H.810 personal health devices: PAN/LAN/TAN interface Part 5N: International normalized ratio: Agent 1 Scope The scope of this Recommendation1 is to provide a test su

26、ite structure and the test purposes (TSS users of this Recommendation are therefore encouraged to investigate the possibility of applying the most recent edition of the Recommendations and other references listed below. A list of the currently valid ITU-T Recommendations is regularly published. The

27、reference to a document within this Recommendation does not give it, as a stand-alone document, the status of a Recommendation. ITU-T H.810 Recommendation ITU-T H.810 (2013), Interoperability design guidelines for personal health systems. IEEE 11073-10418 IEEE 11073-10418-2011, Health informatics Pe

28、rsonal health device communication Part 10418: Device specialization International Normalized Ratio (INR) monitor. ISO/IEEE 11073-20601A ISO/IEEE 11073-20601:2010, Health informatics Personal health device communication Part 20601: Application profile Optimized exchange protocol, including ISO/IEEE

29、11073-20601:2010 Amd 1:2015. with ISO/IEEE 11073-104xx ISO/IEEE 11073-104xx (in force), Health informatics Personal health device communication Device specialization. NOTE Shorthand is used to refer to the collection of device specialization standards that utilize ISO/IEEE 11073-20601A, where xx can

30、 be any number from 01 to 99, inclusive. 3 Definitions 3.1 Terms defined elsewhere This Recommendation uses the following terms defined elsewhere: 3.1.1 agent ISO/IEEE 11073-20601A: A node that collects and transmits personal health data to an associated manager. 3.1.2 manager ISO/IEEE 11073-20601A:

31、 A node receiving data from one or more agent systems. Some examples of managers include a cellular phone, health appliance, set top box, or a computer system. 3.2 Terms defined in this Recommendation None. 4 Abbreviations and acronyms This Recommendation uses the following abbreviations and acronym

32、s: ATS Abstract Test Suite DUT Device Under Test CDG Continua Design Guidelines GUI Graphical User Interface INR International Normalized Ratio Rec. ITU-T H.845.14 (01/2015) 3 IUT Implementation Under Test MDS Medical Device System NFC Near Field Communication PAN Personal Area Network PCT Protocol

33、Conformance Testing PCO Point of Control and Observation PHD Personal Healthcare Device PHDC Personal Healthcare Device Class PHM Personal Health Manager PICS Protocol Implementation Conformance Statement PIXIT Protocol Implementation extra Information for Testing SDP Service Discovery Protocol SOAP

34、 Simple Object Access Protocol TCRL Test Case Reference List TCWG Test and Certification Working Group TP Test Purpose TSS Test Suite Structure USB Universal Serial Bus WDM Windows Driver Model 5 Conventions The key words “SHALL“, “SHALL NOT“, “SHOULD“, “SHOULD NOT“, “MAY“, “MAY NOT“ in this documen

35、t are to be interpreted as in b-ETSI SR 001 262. SHALL is equivalent to must or it is required to. SHALL NOT is equivalent to must not or it is not allowed. SHOULD is equivalent to it is recommended to. SHOULD NOT is equivalent to it is not recommended to. MAY is equivalent to is permitted. MAY NOT

36、is equivalent to it is not required that. NOTE The above-mentioned key words are capitalized for illustrative purposes only and they do not appear capitalized within this Recommendation. Reference is made in the ITU-T H.800-series of Recommendations to different versions of the Continua Design Guide

37、lines (CDG) by a specific designation. The list of terms that may be used in this Recommendation is provided in Table 1. 4 Rec. ITU-T H.845.14 (01/2015) Table 1 List of designations associated with the various versions of the CDG CDG name Transposed as Version Description Designation 2013 plus errat

38、a ITU-T H.810 4.1 CDG 2013 plus errata noting all ratified bugs. 2013 4.0 Release 2013 of the CDG including maintenance updates of CDG 2012 and additional guidelines that cover new functionalities. Endorphin 2012 plus errata 3.1 CDG 2012 plus errata noting all ratified bugs b-CDG 2012. 2012 3.0 Rele

39、ase 2012 of the CDG including maintenance updates of CDG 2011 and additional guidelines that cover new functionalities. Catalyst 2011 plus errata 2.1 CDG 2011 integrated with identified errata. 2011 2.0 Release 2011 of the CDG including maintenance updates of CDG 2010 and additional guidelines that

40、cover new functionalities b-CDG 2011. Adrenaline 2010 plus errata 1.6 CDG 2010 integrated with identified errata 2010 1.5 Release 2010 of the CDG with maintenance updates of CDG Version 1 and additional guidelines that cover new functionalities b-CDG 2010. 1.5 1.0 1.0 First released version of the C

41、DG b-CDG 1.0. 6 Test suite structure (TSS) The test purposes (TPs) for the PAN/LAN/TAN interface have been divided into the main subgroups specified below. Annex A describes the TPs for subgroup 1.3.14 (shown in bold). Group 1: Agent (AG) Group 1.1: Transport (TR) Subgroup 1.1.1: Design guidelines:

42、common (DGC) Subgroup 1.1.2: USB design guidelines (UDG) Subgroup 1.1.3: Bluetooth design guidelines (BDG) Subgroup 1.1.4: Pulse oximeter design guidelines (PODG) Subgroup 1.1.5: Cardiovascular design guidelines (CVDG) Subgroup 1.1.6: Activity hub design guidelines (HUBDG) Subgroup 1.1.7: ZigBee des

43、ign guidelines (ZDG) Subgroup 1.1.8: Glucose meter design guidelines (GLDG) Subgroup 1.1.9: Bluetooth low energy design guidelines (BLEDG) Subgroup 1.1.10: Basic electrocardiograph design guidelines (ECGDG) Subgroup 1.1.11: NFC design guidelines (NDG) Rec. ITU-T H.845.14 (01/2015) 5 Group 1.2: Optim

44、ized exchange protocol (OXP) Subgroup 1.2.1: PHD domain information model (DIM) Subgroup 1.2.2: PHD service model (SER) Subgroup 1.2.3: PHD communication model (COM) Group 1.3: Devices class specializations (CLASS) Subgroup 1.3.1: Weighing scales (WEG) Subgroup 1.3.2: Glucose meter (GL) Subgroup 1.3

45、.3: Pulse oximeter (PO) Subgroup 1.3.4: Blood pressure monitor (BPM) Subgroup 1.3.5: Thermometer (TH) Subgroup 1.3.6: Cardiovascular (CV) Subgroup 1.3.7: Strength (ST) Subgroup 1.3.8: Activity hub (HUB) Subgroup 1.3.9: Adherence monitor (AM) Subgroup 1.3.10: Insulin pump (IP) (Future development) Su

46、bgroup 1.3.11: Peak flow (PF) Subgroup 1.3.12: Body composition analyser (BCA) Subgroup 1.3.13: Basic electrocardiograph (ECG) Subgroup 1.3.14: International normalized ratio (INR) Group 1.4: Personal health device transcoding whitepaper (PHDTW) Subgroup 1.4.1: Whitepaper general requirements (GEN)

47、Subgroup 1.4.2: Whitepaper thermometer requirements (TH) Subgroup 1.4.3: Whitepaper blood pressure requirements (BPM) Subgroup 1.4.4: Whitepaper heart rate requirements (HR) Subgroup 1.4.5: Whitepaper glucose meter requirements (GL) Group 2: Manager (MAN) Group 2.1: Transport (TR) Subgroup 2.1.1: De

48、sign guidelines: common (DGC) Subgroup 2.1.2: USB design guidelines (UDG) Subgroup 2.1.3: Bluetooth design guidelines (BDG) Subgroup 2.1.4: Cardiovascular design guidelines (CVDG) Subgroup 2.1.5: Activity hub design guidelines (HUBDG) Subgroup 2.1.6: ZigBee design guidelines (ZDG) Subgroup 2.1.7: Bl

49、uetooth low energy design guidelines (BLEDG) Subgroup 2.1.8: NFC design guidelines (NDG) Group 2.2: 20601: Optimized exchange protocol (OXP) Subgroup 2.2.1: General (GEN) Subgroup 2.2.2: PHD domain information model (DIM) Subgroup 2.2.3: PHD service model (SER) 6 Rec. ITU-T H.845.14 (01/2015) Subgroup 2.2.4: PHD communica

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