ITU-T H 845 14-2017 Conformance of ITU-T H 810 personal health system Personal Health Devices interface Part 5N International normalized ratio (Study Group 16).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 (04/2017) SERIES H: AUDIOVISUAL AND MULTIMEDIA SYSTEMS E-health multimedia services and applications Interoperability compliance testing of personal health systems (H

2、RN, PAN, LAN, TAN and WAN) Conformance of ITU-T H.810 personal health system: Personal Health Devices interface Part 5N: International normalized ratio Recommendation ITU-T H.845.14 ITU-T H-SERIES RECOMMENDATIONS AUDIOVISUAL AND MULTIMEDIA SYSTEMS CHARACTERISTICS OF VISUAL TELEPHONE SYSTEMS H.100H.1

3、99 INFRASTRUCTURE 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 ser

4、vices H.300H.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 Overvi

5、ew of Mobility 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

6、multimedia 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

7、 services 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 met

8、adata H.750H.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 Personal health systems H.810H.819 Interoperability compliance testing of personal health systems (HRN, PAN,

9、 LAN, TAN and WAN) H.820H.859 Multimedia e-health data exchange services H.860H.869 For further details, please refer to the list of ITU-T Recommendations. Rec. ITU-T H.845.14 (04/2017) i Recommendation ITU-T H.845.14 Conformance of ITU-T H.810 personal health system: Personal Health Devices interfa

10、ce Part 5N: International normalized ratio Summary Recommendation ITU-T H.845.14 provides a test suite structure (TSS) and the test purposes (TP) for devices measuring the international normalized ratio in the Personal Health Devices (PHD) interface, based on the requirements defined in the Recommen

11、dations of the ITU-T H.810 sub-series, of which Recommendation ITU-T H.810 (2016) is the base Recommendation. The objective of this test specification is to provide a high probability of interoperability at this interface. Recommendation ITU-T H.845.14 is a transposition of Continua Test Tool DG2016

12、, Test Suite Structure Part 5N: Device Specializations. Personal Health Device (International Normalized Ratio, INR) (Version 1.3, 2016-09-20), that was developed by the Personal Connected Health Alliance. A number of versions of this specification existed before transposition. This Recommendation i

13、ncludes 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 Recommendation Approval Study Group Unique ID* 1.0 ITU-T H.845.14 2015-01-

14、13 16 11.1002/1000/12274 2.0 ITU-T H.845.14 2016-07-14 16 11.1002/1000/12951 3.0 ITU-T H.845.14 2017-04-13 16 11.1002/1000/13231 Keywords Conformance testing, Continua Design Guidelines, e-health, IEEE 11073 device specialization, international normalized ratio, ITU-T H.810, personal area network, p

15、ersonal connected health devices, Personal Health Devices interface, touch area network. _ * 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/11.1002/1000/11830-en.

16、ii Rec. ITU-T H.845.14 (04/2017) 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 organ of I

17、TU. 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 topics

18、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 prepare

19、d 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 Recommendation may c

20、ontain 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 to expr

21、ess 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 Intellectual Prope

22、rty 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 notice of

23、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 2017 Al

24、l 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 (04/2017) 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 Recomm

25、endation . 2 4 Abbreviations and acronyms 3 5 Conventions 3 6 Test suite structure (TSS) . 5 7 Electronic attachment . 7 Annex A Test purposes . 8 A.1 TP definition conventions . 8 A.2 Subgroup 1.3.14 International normalized ratio (INR) . 9 Bibliography. 50 Electronic attachment: This Recommendatio

26、n 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. iv Rec. ITU-T H.845.14 (04/2017) Introduction This Recommendation is a transposition of

27、 Continua Test Tool DG2016, Test Suite Structure Part 5N: Device Specializations. Personal Health Device (International Normalized Ratio -INR-) (Version 1.3, 2016-09-20), that was developed by the Personal Connected Health Alliance. The table below shows the revision history of this test specificati

28、on; it may contain versions that existed before transposition. Version Date Revision history 1.0 2014-01-24 Initial release for Test Tool DG2013 based on the requirements in b-ITU-T H.810 (2013)/b-CDG 2013. 1.1 2014-04-24 TM Lite users of this Recommendation are therefore encouraged to investigate t

29、he 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 reference to a document within this Recommendation does not give it, as a stand-alone document, the status of a

30、 Recommendation. ITU-T H.810 (2016) Recommendation ITU-T H.810 (2016), Interoperability design guidelines for personal health systems. ISO/IEEE 11073-10418C ISO/IEEE 11073-10418-2014, Health informatics Personal health device communication Part 10418: Device specialization International Normalized R

31、atio (INR) monitor, including ISO/IEEE 11073-10418:2014/Cor 1:2016. https:/www.iso.org/standard/61897.html with https:/www.iso.org/standard/70740.html ISO/IEEE 11073-20601-2015A ISO/IEEE 11073-20601:2010, Health informatics Personal health device communication Part 20601: Application profile Optimiz

32、ed exchange protocol, including ISO/IEEE 11073-20601:2010 Amd 1:2015. https:/www.iso.org/standard/54331.html with https:/www.iso.org/standard/63972.html ISO/IEEE 11073-20601-2016C ISO/IEEE 11073-20601:2016, Health informatics Personal health device communication Part 20601: Application profile Optim

33、ized exchange protocol, including ISO/IEEE 11073-20601:2016/Cor.1:2016. https:/www.iso.org/standard/66717.html with https:/www.iso.org/standard/71886.html 3 Definitions 3.1 Terms defined elsewhere This Recommendation uses the following terms defined elsewhere: 3.1.1 agent ISO/IEEE 11073-20601-2016C:

34、 A node that collects and transmits personal health data to an associated manager. 3.1.2 manager ISO/IEEE 11073-20601-2016C: 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 define

35、d in this Recommendation None. Rec. ITU-T H.845.14 (04/2017) 3 4 Abbreviations and acronyms This Recommendation uses the following abbreviations and acronyms: ATS Abstract Test Suite DUT Device Under Test CDG Continua Design Guidelines CGM Continuous Glucose Monitor GUI Graphical User Interface INR

36、International Normalized Ratio IP Insulin Pump IUT Implementation Under Test MDS Medical Device System NFC Near Field Communication PAN Personal Area Network PCT Protocol Conformance Testing PCO Point of Control and Observation PHD Personal Health Device PHDC Personal Healthcare Device Class PHG Per

37、sonal Health Gateway PICS Protocol Implementation Conformance Statement PIXIT Protocol Implementation extra Information for Testing SABTE Sleep Apnoea Breathing Therapy Equipment SCR Static Conformance Review SDP Service Discovery Protocol SOAP Simple Object Access Protocol TCWG Test and Certificati

38、on 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 Recommendation are to be interpreted as in b-ETSI SR 001 262. SHALL is equivalent to must or

39、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. 4 Rec. ITU-T H.845.14 (07/2016) MAY NOT is equivalent to it is not required that. NOTE T

40、he 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 Guidelines (CDG) by a specific designation. The list

41、of terms that may be used in this Recommendation is provided in Table 1. Table 1 List of designations associated with the various versions of the CDG CDG release Transposed as Version Description Designation 2016 plus errata ITU-T H.810 (2016) 6.1 Release 2016 plus errata noting all ratified bugs b-

42、CDG 2016. 2016 6.0 Release 2016 of the CDG including maintenance updates of the CDG 2015 and additional guidelines that cover new functionalities. Iris 2015 plus errata b-ITU-T H.810 (2015) 5.1 Release 2015 plus errata noting all ratified bugs b-CDG 2015. The 2013 edition of H.810 is split into eigh

43、t parts in the H.810-series. 2015 5.0 Release 2015 of the CDG including maintenance updates of the CDG 2013 and additional guidelines that cover new functionalities. Genome 2013 plus errata b-ITU-T H.810 (2013) 4.1 Release 2013 plus errata noting all ratified bugs b-CDG 2013. 2013 4.0 Release 2013 o

44、f the CDG including maintenance updates of the CDG 2012 and additional guidelines that cover new functionalities. Endorphin 2012 plus errata 3.1 Release 2012 plus errata noting all ratified bugs b-CDG 2012. 2012 3.0 Release 2012 of the CDG including maintenance updates of the CDG 2011 and additional

45、 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 the CDG 2010 and additional guidelines that cover new functionalities b-CDG 2011. Adrenaline 2010 plus errata 1.6 CD

46、G 2010 integrated with identified errata 2010 1.5 Release 2010 of the CDG with maintenance updates of the CDG Version 1 and additional guidelines that cover new functionalities b-CDG 2010. 1.5 1.0 1.0 First released version of the CDG b-CDG 1.0. Rec. ITU-T H.845.14 (04/2017) 5 6 Test suite structure

47、 (TSS) The test purposes (TPs) for the Personal Health Devices 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: Personal Health Device (PHD) Group 1.1: Transport (TR) Subgroup 1.1.1: Design guidelines: Common

48、 (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 design gu

49、idelines (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) Group 1.2: IEEE 20601 Optimized exchange protocol (OXP) Subgroup 1.2.1: PHD domain information model (DIM) Subgroup 1.2.2: PHD se