ITU-T H 845 2-2016 Conformance of ITU-T H 810 personal health devices PAN LAN TAN interface Part 5B Glucose meter Agent (Study Group 16)《ITU-T H 810的个人健康设备的一致性:PAN LAN TAN接口第5B部分:血.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.845.2 TELECOMMUNICATION STANDARDIZATION SECTOR OF ITU (07/2016) SERIES H: AUDIOVISUAL AND MULTIMEDIA SYSTEMS E-health multimedia services and applications Interoperability compliance testing of personal health systems (HR

2、N, PAN, LAN, TAN and WAN) Conformance of ITU-T H.810 personal health devices: PAN/LAN/TAN interface Part 5B: Glucose meter: Agent Recommendation ITU-T H.845.2 ITU-T H-SERIES RECOMMENDATIONS AUDIOVISUAL AND MULTIMEDIA SYSTEMS CHARACTERISTICS OF VISUAL TELEPHONE SYSTEMS H.100H.199 INFRASTRUCTURE OF AU

3、DIOVISUAL 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.300H.349 Direct

4、ory 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 Mobility and Coll

5、aboration, 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 multimedia collaboratio

6、n 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 and applicati

7、ons 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.750H.759 IPTV m

8、ultimedia 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, LAN, TAN and WAN) H.82

9、0H.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.845.2 (07/2016) i Recommendation ITU-T H.845.2 Conformance of ITU-T H.810 personal health devices: PAN/LAN/TAN interface Part 5B: Glucose meter: Agent Sum

10、mary Recommendation ITU-T H.845.2 is a transposition of Continua Test Tool DG2013, Test Suite Structure Part 5B: Device Specializations. Agent (Glucose Meter) (Version 1.4, 2014-01-24), that was developed by the Continua Health Alliance. A number of versions of this specification existed before tran

11、sposition. 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 Recommendation Approval Study Group Unique

12、 ID* 1.0 ITU-T H.845.2 2015-01-13 16 11.1002/1000/12263 2.0 ITU-T H.845.2 2016-07-14 16 11.1002/1000/12939 _ * 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/11.10

13、02/1000/11830-en. ii Rec. ITU-T H.845.2 (07/2016) 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 per

14、manent organ 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, establ

15、ishes the 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 stan

16、dards are 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 Rec

17、ommendation 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

18、 are used 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 I

19、ntellectual 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 re

20、ceived notice 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/

21、ipr/. ITU 2016 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.845.2 (07/2016) iii Table of Contents Page 1 Scope . 1 2 References . 2 3 Definitions 2 3.1 Terms defined elsewhere 2 3.2 Terms define

22、d in this Recommendation . 2 4 Abbreviations and acronyms 2 5 Conventions 3 6 Test suite structure (TSS) . 4 7 Electronic attachment . 6 Annex A Test purposes . 7 A.1 TP definition conventions . 7 A.2 Subgroup 1.3.2: Glucose meter (GL) . 9 Bibliography. 60 Electronic attachment: This Recommendation

23、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.845.2 (07/2016) Introduction This Recommendation is a transposition of Co

24、ntinua Test Tool DG2013, Test Suite Structure Part 5B: Device Specializations. Agent (Glucose meter) (Version 1.4, 2014-01-24), that was developed by the Continua Health Alliance. A number of versions of this specification existed before transposition and these can be found in the table below. Versi

25、on Date Revision history 1.2 2012-10-05 Initial release for Test Tool DG2011. This is the same version as “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

26、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 Recommendation. ITU-T H.810 (2015) Recommendation ITU-T H.810 (2015), Interoperability design guidelines for personal

27、health systems. ITU-T H.810 (2016) Recommendation ITU-T H.810 (2016), Interoperability design guidelines for personal health systems. IEEE 11073-10417 IEEE 11073-10417-2011, Health informatics Personal health device communication Part 10417: Device specialization Glucose meter. ISO/IEEE 11073-20601A

28、 ISO/IEEE 11073-20601:2010, Health informatics Personal health device communication Part 20601: Application profile Optimized exchange protocol, including ISO/IEEE 11073-20601:2010 Amd 1:2015. with ISO/IEEE 11073-104xx ISO/IEEE 11073-104xx (in force), Health informatics Personal health device commun

29、ication Device specialization. NOTE This is shorthand used to refer to the collection of device specialization standards that utilize ISO/IEEE 11073-20601A, where xx can be any number from 01 to 99, inclusive. 3 Definitions 3.1 Terms defined elsewhere This Recommendation uses the following terms def

30、ined 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: A node receiving data from one or more agent systems. Some examples of managers include a cellular phone, health appliance, set to

31、p box, or a computer system. 3.2 Terms defined in this Recommendation None. 4 Abbreviations and acronyms This Recommendation uses the following abbreviations and acronyms: ATS Abstract Test Suite DUT Device Under Test Rec. ITU-T H.845.2 (07/2016) 3 CDG Continua Design Guidelines GUI Graphical User I

32、nterface INR International Normalized Ratio 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 Healthcare Device PHDC Personal Healthcare Device Class PHM Pe

33、rsonal Health Manager PICS Protocol Implementation Conformance Statement PIXIT Protocol Implementation extra Information for Testing SDP Service Discovery Protocol SOAP Simple Object Access Protocol SABTE Sleep Apnoea Breathing Therapy Equipment TCWG Test and Certification Working Group TP Test Purp

34、ose 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 it is required to. SHALL NOT

35、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 is equivalent to it is not required that. NOTE The above-mentioned key words are capitalized for illustrative

36、 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 of terms that may be used in this Recommendation is provided

37、in Table 1. 4 Rec. ITU-T H.845.2 (07/2016) Table 1 List of designations associated with the various versions of the CDG CDG name Transposed as Version Description Designation 2016 plus errata ITU-T H.810 (2016) 6.1 Release 2016 plus errata noting all ratified bugs ITU-T H.810 (2016). 2016 6.0 Releas

38、e 2016 of the CDG including maintenance updates of the CDG 2015 and additional guidelines that cover new functionalities. Iris 2015 plus errata ITU-T H.810 (2015) 5.1 Release 2015 plus errata noting all ratified bugs ITU-T H.810 (2015). 2015 5.0 Release 2015 of the CDG including maintenance updates

39、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-ITU-T H.810 (2013). 2013 4.0 Release 2013 of the CDG including maintenance updates of the CDG 2012 and additional guidelines

40、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 guidelines that cover new functionalities. Catalyst 2011 plus errata 2.1 CDG 2011

41、 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 CDG 2010 integrated with identified errata 2010 1.5 Release 2010 of the CDG with mai

42、ntenance 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. 6 Test suite structure (TSS) The test purposes (TPs) for the PAN/LAN/TAN interface have been divided into the main subgroups specified b

43、elow. Annex A describes the TPs for subgroup 1.3.2: (shown in bold). Group 1: Agent (AG) Group 1.1: Transport (TR) Subgroup 1.1.1: Design guidelines: 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 guide

44、lines (PODG) Rec. ITU-T H.845.2 (07/2016) 5 Subgroup 1.1.5: Cardiovascular design guidelines (CVDG) Subgroup 1.1.6: Activity hub design guidelines (HUBDG) Subgroup 1.1.7: ZigBee design guidelines (ZDG) Subgroup 1.1.8: Glucose meter design guidelines (GLDG) Subgroup 1.1.9: Bluetooth low energy design

45、 guidelines (BLEDG) Subgroup 1.1.10: Basic electrocardiograph design guidelines (ECGDG) Subgroup 1.1.11: NFC design guidelines (NDG) Group 1.2: Optimized 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 communicati

46、on model (COM) Group 1.3: Devices class specializations (CLASS) Subgroup 1.3.1: Weighing scales (WEG) Subgroup 1.3.2: Glucose meter (GL) Subgroup 1.3.3: 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.

47、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) Subgroup 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: Interna

48、tional normalized ratio (INR) Subgroup 1.3.15: Sleep apnoea breathing therapy equipment (SABTE) Group 1.4: Personal health device transcoding whitepaper (PHDTW) Subgroup 1.4.1: Whitepaper general requirements (GEN) Subgroup 1.4.2: Whitepaper thermometer requirements (TH) Subgroup 1.4.3: Whitepaper b

49、lood pressure requirements (BPM) Subgroup 1.4.4: Whitepaper heart rate requirements (HR) Subgroup 1.4.5: Whitepaper glucose meter requirements (GL) Subgroup 1.4.6: Whitepaper weight scale requirements (WS) Group 2: Manager (MAN) Group 2.1: Transport (TR) Subgroup 2.1.1: Design guidelines: Common (DGC) Subgroup 2.1.2: US

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