ANSI P1073.3.3 D08-2003 Draft Standard for Health informatics - Point-of-care medical device communication - Transport profile - IrDA based - Infrared wireless《健康信息学用标准草案.床旁检测用医疗装置.pdf

1、IEEE P1073.3.3 I D8, July 2003 ISOIIEEE PI 1073-30300ID8 ISO/IEEE PI 1073-30300/D08 IEEE 1073.3.3dD08 Date: 2003 July Draft Standard for Health informatics - Point-of-care medical device communication - Transport profile - IrDA based - Infrared wireless Copyright O 2003 by the Institute of Electrica

2、l and Electronics Engineers, Inc. Three Park Avenue New York, New York 1 O01 6-5997, USA All rights reserved. This document is an unapproved draft of a proposed IEEE Standard. As such, this document is subject to change. USE AT YOUR OWN RISK! Because this is an unapproved draft, this document must n

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9、re invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to provide supporting documentation. Page i of 70 Copyright O 2003 IEEE and ISO. All rights reserved This is an unapproved IEEE and IS0 Standards Draft, subject to change. Copyright The

10、Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEENot for ResaleNo reproduction or networking permitted without license from IHS-,-,-IEEE P1073.3.3 I D8, July 2003 ISOIIEEE PI 1073-30300ID8 Abstract: This standard establishes a connection-oriented transpo

11、rt profile and physical layer suitable for medical device communications that use short-range infrared wireless. This standard defines communications services and protocols consistent with specifications of the Infrared Data Association, and are optimized for point-of-care applications at or near th

12、e patient. Keywords: access point, bedside, device interfaces, infrared, Infrared Data Association, IrDA, medical device, medical device communications, Medical Information Bus, MIB, patient, Simple Network Time Protocol, SNTP, point-of-care, POC, point-of-care testing, POCT, wireless Page 2 of 70 C

13、opyright O 2003 IEEE and ISO. All rights reserved This is an unapproved IEEE and IS0 Standards Draft, subject to change. Copyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEENot for ResaleNo reproduction or networking permitted without license

14、from IHS-,-,-IEEE P1073.3.3 I D8, July 2003 ISOIIEEE PI 1073-30300ID8 Introduction This standard defines a communications transport profile. This profile supports short-range, point-to-point infrared wireless communication between medical devices, network access points, computers and other medical d

15、ata systems. This standard is suitable for new device designs but can also be implemented as an adaptation or modification of existing legacy devices. Specifically, this standard describes connection-oriented communications services and protocols consistent with standards of the Infrared Data Associ

16、ation (IrDA). The use of IrDA-infrared is especially appropriate for mobile and portable point-of-care (POC) clinical lab instruments (e.g. glucose meters) and other medical devices that require intermittent point-and-shoot connectivity to a data repository. This standard is one part of the family o

17、f IEEE 1073” (also known as “ISO/IEEE 11073”) standards. It is a companion standard to IEEE Std 1073.3.2” “Standard for Medical Device Communications - Transport Profile - IrDA Based - Cable Connected”. Since both standards use the same IrDA-based transport protocols, software development costs are

18、reduced and the implementation of simple, low-cost cable-to-infrared adapters is facilitated. Like IEEE Std 1073.3.2, this standard is compatible with ISO/IEEE 11073 upper layer standards (e.g., ISO/IEEE standards with document designators ISO/IEEE 11073-lxxxx and ISO/IEEE 11073-2xxxx). It is also f

19、ully compatible with (and largely based on) the Connectivity Industry Consortium (CIC) and the National Committee for Clinical Laboratory Standards (NCCLS) Point-Of-Care Connectiviy; Approved Standard (NCCLS POCT1) Device and Access Point Specification and is capable of supporting the Device Messagi

20、ng Layer upper layer device protocol developed by those organizations for point-of-care diagnostic devices. This standard also extends IEEE Std 1073.3.2” in several important areas: 1. Defines two additional client-server models for medical device interaction that support the NCCLS POCT1 communicati

21、on model. 2. Specifies and provides recommendations for how a network access point acts as a relay between the IrDA TinyTP connection to the medical device and a TCP/P connection to a remote host on the network, and the information that is registered at an Access Point regarding the network services

22、 provided by one or more remote hosts. Although not formally required by this standard, a key objective is that it should be possible to build a Common Access Point that can support ISO/IEEE 11073 and NCCLS point-of-care medical devices as well as handheld Personal Digital Assistants DAS), regardles

23、s of differences between their upper-layer protocols and clinical application. Page 3 of 70 Copyright O 2003 IEEE and ISO. All rights reserved This is an unapproved IEEE and IS0 Standards Draft, subject to change. Copyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS

24、under license with IEEENot for ResaleNo reproduction or networking permitted without license from IHS-,-,-IEEE P1073.3.3 I D8, July 2003 ISOIIEEE PI 1073-30300ID8 Participants and Acknowledgements At the time this standard was completed, the IEEE 1073.3.3 working group had the following membership:

25、Paul Schluter, Editor and Working Group Chair Todd Cooper Kai Hassing Daniel Nowicki Lars Steubesand Andrew Sutton The working group also wishes to recognize the contribution of the Connectivity Industry Consortium Device and Access Point Working Group, which included Paul Schluter, David Ma, Alan G

26、reenburg, Bob Uleski, Imre Trefil, Joe Rogers, Mark Maund and Dan Nowicki, and the overall technical leadership of the Connectivity Industry Consortium provided by Jeff Perry. The IEEE 1073.3.3 Working Group and the IEEE also recognize the efforts and contributions of the NCCLS POCT1 Point-of-Care C

27、onnectivity subcommittee, chaired by Jeffrey A. DuBois, and thank the NCCLS for granting the IEEE permission to use portions of POCT1 (Point-of-Care Connectivity; Approved Standard) in this document. Page 4 of 70 Copyright O 2003 IEEE and ISO. All rights reserved This is an unapproved IEEE and IS0 S

28、tandards Draft, subject to change. Copyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEENot for ResaleNo reproduction or networking permitted without license from IHS-,-,-IEEE P1073.3.3 / D8. July 2003 ISOIIEEE PI 1073-30300/D8 Contents 1 Overv

29、iew 7 1.1 Scope 8 1.2 Purpose . 8 1.3 Standards compatibility . 8 1.4 Audience 9 2 References . 9 3 Definitions. acronyms and abbreviations . 11 3.1 Definitions 11 3.2 Acronyms and abbreviations . 14 4 Goals for this standard . 17 5 Architecture . 17 5.1 Topology 17 5.2 Protocol layering 19 6 Physic

30、al layer 23 5.3 5.4 IrDA primary and secondary roles 20 Client-server models for medical device communication . 22 6.1 IrDA transceiver power options . 23 6.2 Signaling rates . 23 7 Data link layer 25 7.1 IrDA primary and secondary roles . 26 7.2 IrLAP frame . 26 7.3 Procedure model . 27 7.4 Minimum

31、 data link layer requirements . 28 8 Network layer 32 8.1 Discovery information 32 8.2 Information access requirements 34 8.3 Minimum IrLMP multiplexer requirements . 38 9 Transport layer 39 9.1 Maximum transfer unit . 39 9.2 Transport service requirements . 39 9.3 Medical device data language servi

32、ce . 40 10 Time synchronization 41 11 Labeling and conformance requirements . 42 11 . 1 Labeling requirements 42 11.2 Conformance requirements 42 Annex A IrDA physical layer parameters (informative) 43 Page 5 of 70 Copyright O 2003 IEEE and IS0 . All rights reserved This is an unapproved IEEE and IS

33、0 Standards Draft, subject to change . Copyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEENot for ResaleNo reproduction or networking permitted without license from IHS-,-,-IEEE P1073.3.3 / D8. July 2003 ISOIIEEE PI 1073-30300/D8 A.l IrDA phy

34、sical layer optical requirements . 43 A.2 IrDA 3/16 encoding 44 A.3 Background light and electromagnetic compatibility (EMC) 45 A.4 Electrostatic discharge (ESD) immunity 45 A.5 Eye safety 46 Annex B Overview of IEEE Std 1073.3.2 (informative) 47 Annex C IEEE 1073.3.2 cable to infrared adapter (info

35、rmative) . 50 Annex D Marking guidelines (informative) 52 D.l Labeling for infrared ports 52 D.2 Labeling examples . 53 Annex E IrDA conformance requirements (normative) 55 E.l IrDA link access protocol (IrLAP) implementation . 55 E.2 IrDA link management protocol (IrLMP) implementation . 56 E.3 IrD

36、A tiny transport protocol (TinyTP) implementation 57 E.4 Interoperability . 57 E.5 Testing and quality assurance . 57 Annex F Networked Access Points for NCCLS POCTI Devices (normative) 58 F.l Transparent TinyTP to TCP/IP connection 58 F.2 Registering Data Manager(s) in the Access Point IAS 58 F.3 C

37、ontrol and data flow between a Device, Access Point and Data Manager 59 F.4 Primary POC Device and secondary Access Point (Case I) 60 F.5 Secondary POC Device and primary Access Point (Case il) . 62 F.6 TCP/IP buffering and push mechanism . 64 Annex G Networked Access Points for ISO/IEEE 11073 Devic

38、es (informative) . 65 G.l Registering ISO/IEEE 11073 device managers in the Access Point IAS 65 G.2 Secondary ISO/IEEE 11073 DCC and primary BCC /Access Point (Case ill) 66 Annex H Compatibility with IEEE 1073.3.2 and NCCLS POCTI (informative) 68 Annex I Bibliography (informative) . 70 Copyright O 2

39、003 IEEE and IS0 . All rights reserved This is an unapproved IEEE and IS0 Standards Draft, subject to change . Page 6 of 70 Copyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEENot for ResaleNo reproduction or networking permitted without licen

40、se from IHS-,-,-IEEE P1073.3.3 I D8, July 2003 ISOIIEEE PI 1073-30300ID8 Draft Standard for Health informatics - Point-of-care medical device communication - Transport profile - IrDA based - Infrared wireless 1 Overview This standard is divided into eleven clauses, as follows: e e e e e e e e e e e

41、Clause 1 provides an overview of this standard. Clause 2 lists references to other standards that are useful in applying this standard. Clause 3 provides definitions and abbreviations. Clause 4 provides goals for this standard. Clause 5 provides an overview of network topology and layering. Clause 6

42、 provides a profile of the physical layer. Clause 7 provides a profile of the data link layer. Clause 8 provides a profile of the network layer. Clause 9 provides a profile of the transport layer. Clause 10 describes the optional time synchronization service. Clause 1 1 provides labeling and conform

43、ance requirements. This standard also contains nine annexes, as follows: Annex A describes the Infrared Data Assocation (IrDA) infrared physical layer. Annex B provides an overview of the IEEE Std 1073.3.2 cable-connected physical layer. Annex C provides an example of an IEEE 1073.3.2 cable-connecte

44、d infrared adapter. Annex D provides marking guidelines. Annex E defines the IrDA profile specifications adapted from the IrDA implementation guidelines. Annex F defines networked Access Points for NCCLS POCT1 diagnostic devices. Annex G provides guidelines for networked Access Points for ISOLEEE 11

45、073 devices. Annex H discusses lower-layer compatibility with other medical communication standards. Annex I provides bibliographical references. Page 7 of 70 Copyright O 2003 IEEE and ISO. All rights reserved This is an unapproved IEEE and IS0 Standards Draft, subject to change. Copyright The Insti

46、tute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEENot for ResaleNo reproduction or networking permitted without license from IHS-,-,-IEEE P1073.3.3 I D8, July 2003 ISOIIEEE PI 1073-30300ID8 1.1 Scope The scope of this standard is to define an IrDA-based transp

47、ort profile for medical device communication that uses short-range infrared, as a companion standard to IEEE Std 1073.3.2, which specifies a cable- connected physical layer. This standard also supports use cases consistent with industry practice for handheld Personal Digital Assistants DAS) and netw

48、ork access points that support IrDA-infrared communication. 1.2 Purpose The purpose of this standard is to provide connection-oriented communication services and protocols consistent with IrDA specifications, using short-range infrared as the physical layer. This extends and complements IEEE Std 107

49、3.3.2, which specifies a cable-connected physical layer. The use of IrDA- infrared is appropriate for mobile and portable ?point-of-care? clinical lab instruments (e.g. glucose meters) and other medical devices that require intermittent ?point-and-shoot? connectivity to a data repository. This standard utilizes the work embodied in the Connectivity Industry Consortium and National Committee for Clinical Laboratory St