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 (04/2017) 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 system: Personal Health Devices interface Part 5B: Glucose meter Recommendation ITU-T H.845.2 ITU-T H-SERIES RECOMMENDATIONS AUDIOVISUAL AND MULTIMEDIA SYSTEMS CHARACTERISTICS OF VISUAL TELEPHONE SYSTEMS H.100H.199 INFRASTRUCTURE O
3、F 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.300H.349 Di
4、rectory 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
5、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 multimedia collabor
6、ation 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 appli
7、cations 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 IP
8、TV 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, LAN, TAN and WAN)
9、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.845.2 (04/2017) i Recommendation ITU-T H.845.2 Conformance of ITU-T H.810 personal health system: Personal Health Devices interface Part 5B: Glucose m
10、eter Summary Recommendation ITU-T H.845.2 provides a test suite structure (TSS) and the test purposes (TP) for glucose meters in the Personal Health Devices (PHD) interface, based on the requirements defined in the Recommendations of the ITU-T H.810 sub-series, of which Recommendation ITU-T H.810 (2
11、016) 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.845.2 is a transposition of Continua Test Tool DG2016, Test Suite Structure Part 5B: Device Specializations. Personal Health Device
12、 (Glucose Meter) (Version 1.6, 2016-09-20), that was developed by the Personal Connected Health Alliance. A number of versions of this specification existed before transposition. This Recommendation includes an electronic attachment with the protocol implementation conformance statements (PICS) and
13、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.845.2 2015-01-13 16 11.1002/1000/12263 2.0 ITU-T H.845.2 2016-07-14 16 11.1002/1000/12939 3.0 ITU-T H.845.2 2017-04
14、-13 16 11.1002/1000/13220 Keywords Conformance testing, Continua Design Guidelines, e-health, glucose meter, IEEE 11073 device specialization, ITU-T H.810, personal area network, personal connected health devices, Personal Health Devices interface, touch area network. _ * To access the Recommendatio
15、n, 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. ii Rec. ITU-T H.845.2 (04/2017) FOREWORD The International Telecommunication Union (ITU) is the United Nations specializ
16、ed agency in the field of telecommunications, information and communication technologies (ICTs). The ITU Telecommunication Standardization Sector (ITU-T) is a permanent organ of ITU. ITU-T is responsible for studying technical, operating and tariff questions and issuing Recommendations on them with
17、a view to standardizing telecommunications on a worldwide basis. The World Telecommunication Standardization Assembly (WTSA), which meets every four years, establishes the topics for study by the ITU-T study groups which, in turn, produce Recommendations on these topics. The approval of ITU-T Recomm
18、endations 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 prepared on a collaborative basis with ISO and IEC. NOTE In this Recommendation, the expression “Administration“ is used for con
19、ciseness to indicate both a telecommunication administration and a recognized operating agency. Compliance with this Recommendation is voluntary. However, the Recommendation may contain certain mandatory provisions (to ensure, e.g., interoperability or applicability) and compliance with the Recommen
20、dation 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 express requirements. The use of such words does not suggest that compliance with the Recommendation is required of any party
21、. INTELLECTUAL PROPERTY RIGHTSITU draws attention to the possibility that the practice or implementation of this Recommendation may involve the use of a claimed Intellectual Property Right. ITU takes no position concerning the evidence, validity or applicability of claimed Intellectual Property Righ
22、ts, 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 intellectual property, protected by patents, which may be required to implement this Recommendation. However, implementer
23、s 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 All rights reserved. No part of this publication may be reproduced, by any means whatsoever, without the prior written perm
24、ission of ITU. Rec. ITU-T H.845.2 (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 Recommendation . 2 4 Abbreviations and acronyms 3 5 Conventions 3 6 Test suite structure (TSS) . 5 7 Electronic attachment . 7 A
25、nnex A Test purposes . 8 A.1 TP definition conventions . 8 A.2 Subgroup 1.3.2: Glucose meter (GL) . 10 Bibliography. 61 Electronic attachment: This Recommendation includes an electronic attachment with the protocol implementation conformance statements (PICS) and the protocol implementation extra in
26、formation for testing (PIXIT) required for the implementation of Annex A. iv Rec. ITU-T H.845.2 (04/2017) Introduction This Recommendation is a transposition of Continua Test Tool DG2016, Test Suite Structure Part 5B: Device Specializations. Personal Health Device (Glucose Meter) (Version 1.6, 2016-
27、09-20), that was developed by the Personal Connected Health Alliance. The table below shows the revision history of this test specification; it may contain versions that existed before transposition. Version Date Revision history 1.2 2012-10-05 Initial release for Test Tool DG2011. This is the same
28、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 the currently valid ITU-T Recommendations is regularly published. The reference to a document w
29、ithin this Recommendation does not give it, as a stand-alone document, the status of a Recommendation. ITU-T H.810 (2016) Recommendation ITU-T H.810 (2016), Interoperability design guidelines for personal health systems. ISO/IEEE 11073-10417 ISO/IEEE 11073-10417:2014, Health informatics Personal hea
30、lth device communication Part 10417: Device specialization Glucose meter. https:/www.iso.org/standard/61896.html ISO/IEEE 11073-20601-2015A ISO/IEEE 11073-20601:2010, Health informatics Personal health device communication Part 20601: Application profile Optimized exchange protocol, including ISO/IE
31、EE 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 Optimized exchange protocol, including ISO/
32、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: A node that collects and transmits pe
33、rsonal 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 defined in this Recommendation None. Rec. IT
34、U-T H.845.2 (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 International Normalized Ratio IP Insul
35、in 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 Personal Health Gateway PICS Protocol Impl
36、ementation 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 Certification Working Group TP Test Purpose TSS Te
37、st 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 is equival
38、ent 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.845.2 (07/2016) MAY NOT is equivalent to it is not required that. NOTE The above-mentioned key words are capital
39、ized 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 of terms that may be used in this Recomm
40、endation 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-CDG 2016. 2016 6.0 Release 2016 of the C
41、DG 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 eight parts in the H.810-series. 2015 5.0 Re
42、lease 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 of the CDG including maintenance updates
43、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 guidelines that cover new functionaliti
44、es. 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 CDG 2010 integrated with identified errata
45、 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.845.2 (04/2017) 5 6 Test suite structure (TSS) The test purposes (TPs) for the Pe
46、rsonal Health Devices interface have been divided into the main subgroups specified below. Annex A describes the TPs for subgroup 1.3.2: (shown in bold). Group 1: Personal Health Device (PHD) Group 1.1: Transport (TR) Subgroup 1.1.1: Design guidelines: Common (DGC) Subgroup 1.1.2: USB design guideli
47、nes (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 guidelines (ZDG) Subgroup 1.1.8: Glucose me
48、ter 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
49、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 1.3.3: Pulse oximeter (PO) Subgroup 1.3.4: Blood pressure monitor (BPM) Subgroup 1.3.5: Thermometer (TH) Subgroup 1.3.6: Cardiovascular (
