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1、ISO/IEEE PI 1073-20101/D08 IEEE 1073.2.1 .I dD08 Date: 2003 July Draft Standard for Health informatics - Point-of-care medical device communication - Application profiles - Base standard Copyright O 2003 by the Institute of Electrical and Electronics Engineers, Inc. Three Park Avenue New York, New Y

2、ork 10016-5997, 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 not be utilized for any conformancekompliance purposes. Permission is

3、hereby granted for IEEE Standards Committee participants to reproduce this document for purposes of IEEE standardization activities only. Prior to submitting this document to another standards development organization for standardization activities, permission must first be obtained from the Manager

4、, Standards Licensing and Contracts, IEEE Standards Activities Department. Other entities seeking permission to reproduce this document, in whole or in part, must obtain permission from the Manager, Standards Licensing and Contracts, IEEE Standards Activities Department. IEEE Standards Activities De

5、partment Standards Licensing and Contracts 445 Hoes Lane, P.O. Box 1331 Piscataway, NJ 08855-1 331, USA IS0 Copyright notice This IS0 document is a working draft or committee draft and is copyright-protected by ISO. While the reproduction of working drafts or committee drafts in any form for use by

6、participants in the IS0 standards development process is permitted without prior permission from ISO, neither this document nor any extract from it may be reproduced, stored or transmitted in any form for any other purpose without prior written permission from ISO. Requests for permission to reprodu

7、ce this document for the purpose of selling it should be addressed as shown below or to ISOs member body in the country of the requester: Audrey Dickerson LW:CWSOESS. arg) IS0 TC215 secretariat HIMSS Reproduction for sales purposes may be subject to royalty payments or a licensing agreement. Violato

8、rs may be prosecuted. Warning This document is not an IS0 International Standard. It is distributed for review and comment. It is subject to change without notice and may not be referred to as an International Standard. Recipients of this document are invited to submit, with their comments, notifica

9、tion of any relevant patent rights of which they are aware and to provide supporting documentation. 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 107

10、3.2.1 .I m/D08 (ISO/IEEE 11073-20101/D08) Revision history Copyright O 2002. IEEE and ISO. All Rights Reserved. This is an unapproved IEEE and IS0 Standards Draft, subject to change. 2003-07 2 Copyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IE

11、EENot for ResaleNo reproduction or networking permitted without license from IHS-,-,-IEEE 1073.2.1 .I m/D08 (ISO/IEEE 11073-20101/D08) 2003-07 Revision number do1 d02 d03 DO4 DO5 DO6 Date 1996-08 thru 2000-12 2001 -09-07 2001-12-31 2002-03-29 2002-04-15 2002-12-16 Remarks Various drafts identified i

12、n IEEE 1073.2 as Rev. 0.1, the last being Rev. 1.08. PreCD version transferring existing WI number to IS0 11073-20101, based on London and Seoul meeting authorizations. Also included are several editorial changes based on review of d1.08c; specifically, Editorial revision of Annex A concerning Medic

13、al Device Encoding Rules (MDER); some additional review to correlate with referenced IS0 standards should be done prior to CD ballot. Reservation of defmitions (see clause 6.6.4 and Annex C) related to a prospective time synchronization protocol to be based on SNTP; this topic replaces the “Transpor

14、t Independent Sub-Layer (TISL)”, which has been obsoleted from this version. Editorial revision of Annex F concerning abstract syntax and encodings of Association Request and Response PDUs based on recent review PreCD version updating feedback from d02, which was distributed at the Salt Lake City me

15、eting in October, 2001. 1 1 Update References to reflect IS0 11073/IEEE 1073 harmonization see Clause 21 Clarify application of Simple Network Time Protocol (SNTP) see Clause 6.6.4 and Annex C. Clarify application of ROSE* and CMIP* “scope” semantics and syntaxes see Annex E.2.1 and E2.21. 1 Resolve

16、d comments to fmalize for ballot submission Update based on review by IEEE Editor and IEEE 1073 Chair Revised a number of harmonization references Added several additional PDU examples. 1 1 Final edit before submitting to IEEE for publishing process- d05 passed ballot and does not require formal bal

17、lot resolution but is subject to editing to address specific issues raised during ballot. These include: 1 1 Several clarifications regarding harmonization, esp. re: CEN. Clarification re fEed-length integer data types and IS0 C programming language standard (see A.4). Clarification re: “abort” resp

18、onsibilities (see E.l. 1.7). 1 Issues raised after ballot include: . . . . . . . . . . . Removed the “linked command” defmition - it is never used. Added the multipleReply( 1) functional units bit definition in the association user information; indicated other bits that are “reserved” - already defm

19、ed in ACSE. Added the mib(4) arc to the object identifiers in annex B as well as updating the text in E.4 to reflect the right IS0 OID arch other clarifications to the comments were also included Changed the contact on the title page from Todd Sandler (ASTM) to Audrey Dickerson (HIMSS) 1 Changed the

20、 definition of IS0 1 Changed NOM- to MDC- 1 1 1 1 1 Copyright O 2002. IEEE and ISO. All Rights Reserved. This is an unapproved IEEE and IS0 Standards Draft, subject to change. 4 Copyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEENot for Resal

21、eNo reproduction or networking permitted without license from IHS-,-,-IEEE 1073.2.1 . 1 “/DO8 (ISO/IEEE 11073-20101/D08) Contents 2003-07 1 Overview 8 1 . 1 1.3 Goals . 9 1.4 Audience 9 2 References 9 Scope 8 1.2 Purpose . 8 3 Definitions and abbreviations 10 3.1 Definitions 10 3.2 Acronyms and abbr

22、eviations 11 4 Conventions 13 5 Requirements 13 5.1 Communication Model . 13 5.2 Information Model 14 6 Communication model . 15 6.1 General 15 6.2 ACSE Protocol . 19 6.2. I General 19 6.2.2 ACSE Services 20 6.2.3 ACSE ASN . 1 Message Definition 21 6.2.4 ACSE User Information Fields . 21 Session Lay

23、er Protocol 22 6.3.1 General 22 6.3.2 Session Layer Services . 22 6.3.3 Session Layer Message Definitions . 22 Presentation Layer Protocol . 23 6.4.1 General 23 6.4.2 Presentation Layer Services 23 6.4.3 Presentation Layer Messages . 24 6.5 ROSE Protocol 24 6.5.1 General 24 6.5.2 ROSE Services 24 6.

24、5.3 ROSE Message Definitions . 24 CMDISE Protocol (CMDIP) 25 6.6.1 General 25 6.6.2 CMDISE Services 25 6.6.3 CMDIP Message Definitions 25 6.6.4 Simple Network Time Protocol (SNTP) 26 7 Information model 26 6.3 6.4 6.6 Copyright O 2002 . IEEE and IS0 . All Rights Reserved . This is an unapproved IEEE

25、 and IS0 Standards Draft. subject to change . 5 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 1073.2.1 . 1 m/D08 (ISO/IEEE 11073-20101/D08) 2003-07 7

26、.1 Object model 26 7.2 Format model . 26 7.2.1 Syntax 26 7.2.2 Compatibility 26 8 Conformance . 27 8.1 Scope 27 8.2 Object Identifier Administration 27 8.3 MDAP Subset Conformance 27 8.4 Implementation Conformance 28 Annex A Medical Device Encoding Rules MDER (normative) 29 A.l General . 29 A.2 Supp

27、orted ASN.l Syntax 29 A.3 Byte Order . 31 A.4 Encodings 33 A.4.1 General . 33 A.4.2 INTEGER 33 A.4.3 BIT STRING 34 A.4.4 OCTET STRING 35 A.4.5 SEQUENCE 36 A.4.6 SEQUENCE OF 36 A.4.7 CHOICE 37 A.4.8 ANY DEFINED BY and INSTANCE OF . 39 A.5 Floating Point Data Structure 40 Annex B Allocation of identif

28、iers (normative) 42 B.l Introduction 42 B.2 Allocation framework 42 B.3 Derivation examples . 44 Annex C Time Synchronization (informative) 45 C.l Purpose 45 C.2 Scope . 45 Annex D Dynamic model (informative) . 46 C.3 Specification . 45 Annex D Dynamic model (informative) . 46 Annex E Abstract synta

29、x (normative) . 49 E.l mOSI extensions . 49 E . 1.1 Session 49 E.l . 1 . 1 Session Connect SPDU (CN) 50 E.l . 1 . 2 Session Accept SPDU (AC) 50 E.l . 1 . 3 Session Refuse SPDU (RF) 51 E.l . 1 . 4 Session Finish SPDU (FN) 51 E.l . 1 . 5 Session Disconnect SPDU (DN) 51 E.l . 1 . 6 Session Data Transfe

30、r SPDU (DT) 51 . Copyright O 2002 . IEEE and IS0 . All Rights Reserved . This is an unapproved IEEE and IS0 Standards Draft. subject to change . 6 Copyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEENot for ResaleNo reproduction or networking

31、permitted without license from IHS-,-,-IEEE 1073.2.1 . 1 m/D08 (ISO/IEEE 11073-20101/D08) E.l . 1 . 7 Session Abort SPDU (AB) . 52 E.l . 1 . 8 Session Abort Accept SPDU (AA) . 52 E.l . 1 . 9 MDAP Session Layer Extensions . 52 E.1.2.1 CP (connect presentation) . 55 E.1.2.2 CPA (connect presentation a

32、ccept) . 56 E.1.2.3 CPR (connect presentation reject) 57 E.1.2.4 ARP (abnormal release provider) . 57 E.1.2.5 ARU (abnormal release user) . 57 E.1.2.6 TD (presentation data) 58 E.1.2.7 MDAP-TD (presentation data for MDAP presentation layer extension) 58 E.1.2.8 Presentation Layer User Data Type Defi

33、nitions 59 E . 1.3 Application . 60 E.1.3.1 Association . 60 E.2 ASN.l Modules . 62 E.2.1 ROSE* 62 E.2.1 . 1 Differences to ISOIIEC ROSE . 64 E.2.1.2 ROSE* Message Fields 65 E.2.1 . 3 Handling of Linked Replies . 66 E.2.2 CMIP* . 67 E.2.3 Associate User Info . 72 E.3 Abstract Syntax Extensions . 73

34、E.4 Management Information Base (MIB) definitions . 73 Appendix F PDU Examples (informative) . 74 F.l Association 74 F.2 Configuration . 74 F.3 Operation . 74 Annex G Specialization of Abstract Syntax Notation One (informative) . 89 G.l Introduction . 89 G.2 ASN.l specialization . 90 Annex H Compati

35、bility Cases (informative) . 94 H.l ANY DEFINED BY 94 H . 1.1 Migrating to current ASN . 1 notation 94 H . 1.2 The TYPE-IDENTIFER information object class in ASN . 1 94 H . 1.2 Instance-of TYPE encoding in BER 95 Annex I Bibliography (informative) . 96 E . 1.2 Presentation 55 2003-07 Copyright O 200

36、2 . IEEE and IS0 . All Rights Reserved . This is an unapproved IEEE and IS0 Standards Draft. subject to change . 7 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 I

37、HS-,-,-IEEE 1073.2.1 .I m/D08 (ISO/IEEE 11073-20101/D08) 2003-07 DRAFT Health informatics - Point-of-care medical device communication - Application profiles - Base standard 1 Overview This standard is divided into eight clauses, as follows: O O Clause 1 provides the scope of this standard Clause 2

38、lists references to other standards that are useful in applying this standard Clause 3 provides definitions and abbreviations. Clause 4 provides conventions. Clause 5 provides requirements. Clause 6 provides a communication, or protocol and service model. Clause 7 provides an information, or object

39、model Clause 8 provides conformance requirements. This standard also contains nine annexes, as follows (* denotes Normative). 0 Annex A* defines the specialized Medical Device Encoding Rules. Annex B* describes the allocation of object identifiers. Annex C provides references to time synchronization

40、 protocols applied by this standard. Annex D includes state transition diagrams as part of the dynamic model. Annex E* provides abstract syntax which are extensions to leveraged standards, such as mOSI, or which are specific to this standard. Annex F includes examples of a number of protocol data un

41、it (pdu) examples. Annex G describes a specialization of Abstract Syntax Notation One. Annex H deals with compatibility, initially of ASN.l 1988/90 to 1994 update Annex I provides a bibliography of useful references. 1.1 Scope The scope of this standard is upper-layer (.e. IS0 OS1 Application, Prese

42、ntation, and Session) services and protocols for information exchange under IEEE 1 073m Standards for Medical Device Communications (MDC). This standard is the Base Standard of the IEEE 1073.2m, Medical Device Application Profiles (MDAP), as harmonized through CEN and ISO. 1.2 Purpose The purpose of

43、 this standard is to define MDC upper layer application, or IS0 “A-type” profiles for interchange of data which are defined by the Medical Device Data Language (MDDL) format, or IS0 “F-type” profiles (IEEE 1073.1 m-series). Copyright O 2002. IEEE and ISO. All Rights Reserved. This is an unapproved I

44、EEE and IS0 Standards Draft, subject to change. a 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 1073.2.1 .I m/D08 (ISO/IEEE 11073-20101/D08) 2003-07

45、1.3 Goals The primary goal of MDAP standards is to support MDC upper layer data interchange, based on MDDL, among a wide range, by type and scale, of future and current devices for use in point-of-care settings in the acute-care sections of hospitals. 1.4 Audience The primary user of the MDAP standa

46、rds is a software engineer who is creating a MDC system or attempting to establish an interface to one. Since this family of standards is based largely upon International Standardization Profiles, familiarity with a range of related standards and technologies is useful if not necessary; the followin

47、g are recommended as a minimum background: a) IEEE 1073m architecture, especially IEEE Std 1073m, IEEE Std P1073.1 .2.Im, and lower-layers standards (e.g., IEEE Std 1 073.3.2m) b) ISOs open systems interconnection (OSI) layered architecture, primarily the “upper layers”, e.g. application, presentati

48、on and session, and secondarily c) Systems Management d) object-oriented analysis and design e) machine language theory 2 References This standard shall be used in conjunction with the following publications. When the following standards are superceded by an approved revision, the revision shall app

49、ly. IS0 1 1073-00000/IEEE PI 073m, Health informatics - Point-of-care medical device communication - Framework and Overview IS0 11073-10101/IEEE 1073.1 .I .ITM, Health informatics - Point-of-care medical device communication - Nomenclature IS0 11073-10201/IEEE 1073.1.2.1 TM, Health informatics - Point-of-care medical device communication - Domain information model Referred to hereinafter as the “DIM”. IS0 11 073-201 02/1EE