1、 IEEE P1073-1.2.1/D05c ISO/IEEE P11073-10201/D05c Date: July 2002P1073-1.2.1/D06 ISO/IEEE P11073-10201/D06 Date: May 2003 Draft Health Informatics - Point-of-care medical device communications - Domain information model Copyright 20022003 by the Institute of Electrical and Electronics Engineers, Inc
2、. Three Park Avenue New York, New York 10016-5997, USA All rights reserved. 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 utilize
3、d for any conformance/compliance purposes. Permission is 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 activ
4、ities, permission must first be obtained from the Manager, 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 Stan
5、dards Activities Department. IEEE Standards Activities Department Standards Licensing and Contracts 445 Hoes Lane, P.O. Box 1331 Piscataway, NJ 08855-1331, USA ISO Copyright notice This ISO document is a working draft or committee draft and is copyright-protected by ISO. While the reproduction of wo
6、rking drafts or committee drafts in any form for use by participants in the ISO 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
7、 permission from ISO. Requests for permission to reproduce 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: Todd Sandler (tsandlerastm.org) ISO TC215 secretariat ASTM as appropriate, of the Copyright Manager of the
8、 ISO member body responsible for the secretariat of the TC or SC within the framework of which the draft has been prepared Reproduction for sales purposes may be subject to royalty payments or a licensing agreement. Violators may be prosecuted. Copyright The Institute of Electrical and Electronics E
9、ngineers, Inc. Provided by IHS under license with IEEENot for ResaleNo reproduction or networking permitted without license from IHS-,-,-IEEE P1073.1.2.1/Draft 5c 6 ISO/IEEE P11073-10201 2002-07-292003-05-01 Copyright 2003 IEEE and ISO. All rights reserved. 2 This is an unapproved IEEE and ISO Stand
10、ards Draft, subject to change.Revision history Revision Date Remarks D01 D02 2001-08-15 Version for discussion at the London ISO TC215 meeting D03 2002-01-06 Version incorporating feedback from IEEE P1073, CEN TC251 PT40 (FEF) and ISO TC215 WG2 D04 2002-03-11 Version incorporating feedback from IEEE
11、 Staff D05 2002-06-26 Ballot resolution version, incorporating feedback from the ballot group D05b 2002-07-08 Clean-up after review of changed items D05c 2002-07-29 Further refinement of the complex metric object to allow recursion of the composition relation to the Metric D06 2003-02-20 Changed NOM
12、_ to MDC_ Added support for metric IDs from non-SCADA partitions Added Enumeration range labels Deleted Clock:Time-Support:relative-accuracy attribute Clarified Clock:Date-Time-Status:clock-accuracy notes Removed dates from References section. Resolved circular definition for “event” Added FEF parti
13、tion definition Added episodic scanner scan “period” notes Added usage note for MDS:Mds-Set-Status “authorization” attribute. Misc. editorial changes. Reviewing this document This working document is circulated to the TC in order to enable comment on: General format The editor is aware of inconsiste
14、ncies in presentation style and so-called auto-numbering in this version, these will be corrected when other comments resulting from the CD process are addressed. Specific provisions Such as technical inconsistencies, etc. Comments: Comments will be welcomed in the following format. Please do not si
15、gnificantly alter the table format - it makes collation of comments unnecessarily time-consuming. Key: Who: your initials (give full contact details here): . Where: location in text (give clause (and sub-clauses), paragraph number and line number in clause Type: G= general, T = typo, m = minor, M =
16、major, S = suggestion Comment: nature of problem/agreement Action: acceptable resolution of problem No Who Where Type Comment Suggested Action Done 1. 2. Copyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEENot for ResaleNo reproduction or netw
17、orking permitted without license from IHS-,-,-IEEE P1073.1.2.1/Draft 5c6 ISO/IEEE P11073-10201 2002-07-292003-05-01 Copyright 2003 IEEE and ISO. All rights reserved. This is an unapproved IEEE and ISO Standards Draft, subject to change. 3 3. 4. 5. Please send comments to: Kai Hassing, Philips Medica
18、l Systems, Hewlett-Packard-Strasse 2, 71034 Boeblingen, GERMANY Telephone: +49 (7031) 463-1064 Fax: +49 (7031) 463-2944 Email: Kai_H Copyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEENot for ResaleNo reproduction or networking permitted with
19、out license from IHS-,-,-IEEE P1073.1.2.1/Draft 5c 6 ISO/IEEE P11073-10201 2002-07-292003-05-01 Copyright 2003 IEEE and ISO. All rights reserved. 4 This is an unapproved IEEE and ISO Standards Draft, subject to change.Table of Contents Foreword 6 Introduction6 1 Scope .7 2 Normative References 7 3 D
20、efinitions .10 4 Abbreviations and Acronyms.14 5 Requirements 15 6 Domain information model.15 6.1 General 15 6.2 Package Diagram - Overview 18 6.3 Model for the Medical Package 20 6.4 Model for the Alert Package. 23 6.5 Model for the System Package 25 6.6 Model for the Control Package. 27 6.7 Model
21、 for the Extended Services Package 32 6.8 Model for the Communication Package. 35 6.9 Model for the Archival Package . 37 6.10 Model for the Patient Package . 39 6.11 Domain Information Model - Dynamic Model. 40 7 Domain Information Model - Object Definitions46 7.1 General 46 7.2 Top Object 55 7.3 O
22、bjects in the Medical Package. 56 7.4 Objects in the Alert Package 101 7.5 Objects in the System Package . 108 7.6 Objects in the Control Package . 132 7.7 Objects in the Extended Services Package . 149 7.8 Objects in the Communication Package 164 7.9 Objects in the Archival Package 174 7.10 Objects
23、 in the Patient Package 182 8 Service Model for Communicating Systems .186 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 P1073.1.2.1/Draft 5c6 ISO/IE
24、EE P11073-10201 2002-07-292003-05-01 Copyright 2003 IEEE and ISO. All rights reserved. This is an unapproved IEEE and ISO Standards Draft, subject to change. 5 8.1 General 186 8.2 Communicating Systems . 187 8.3 General Service Model Overview. 187 8.4 General Object Management Services Definition 19
25、0 9 The Medical Data Information Base Nomenclature 196 10 Conformance Model197 10.1 Applicability. 197 10.2 Conformance Specification 197 10.3 Implementation Conformance Statements. 198 Copyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEENot f
26、or ResaleNo reproduction or networking permitted without license from IHS-,-,-IEEE P1073.1.2.1/Draft 5c 6 ISO/IEEE P11073-10201 2002-07-292003-05-01 Copyright 2003 IEEE and ISO. All rights reserved. 6 This is an unapproved IEEE and ISO Standards Draft, subject to change.Foreword This document has be
27、en prepared under the direction of the International Standards Organization (ISO). It was prepared and amended in response to comments during the review process by Working Group 2 of ISO/TC215. Introduction This standard should primarily be read in conjunction with ISO/IEEE11073-0000, Health Informa
28、tics - Point-of-care medical device communications - Framework and overview, which gives the scenarios that it is based upon. The purpose of this document is the definition of a common model for access of this information, taking account of the demands resulting from real-time communication. Develop
29、ment of this standard was based upon: The ISO Open Systems Interconnection Basic Reference Model. Identification and definition of information objects and their relationships based upon a set of scenarios with application of the object-oriented analysis and design methodology. Within CEN/TC251, duri
30、ng the production of the precursor to this standard, the approach proposed by Coad and Yourdon was followed. During the further development of this standard the notation was then converted to the more popular Unified Modelling Language (UML). Work on Standardization of Interoperability for Medical D
31、evices has been carried on by various groups for more than fifteen years. The development of this standard would not have been possible without previous work done particularly by the IEEE Committee P 1073, CEN TC251 WGIV (and previously WG5) and a number of national organizations in the field of Bio
32、medical Engineering and Health Informatics. 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 P1073.1.2.1/Draft 5c6 ISO/IEEE P11073-10201 2002-07-292003-
33、05-01 Copyright 2003 IEEE and ISO. All rights reserved. This is an unapproved IEEE and ISO Standards Draft, subject to change. 7 Draft Health Informatics - Point-of-care medical device communications - Domain information model 1 Scope Within the context of the ISO/IEEE 11073, Health Informatics-Poin
34、t-of-care medical device communications set of standards, this standard addresses the definition and structuring of information that is communicated or referred to in communication between application entities. This standard provides a “common“ representation of all application entities present in t
35、he application processes within the various devices independent of the syntax. The definition of association control and lower layer communication is outside the scope of this standard. 2 Normative References The following referenced documents are indispensable for the application of this document.
36、For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 7498-1 1994 Information technology - Open systems interconnection - Basic reference model ISO 7498-2 1988 Information processing systems
37、 - Open systems interconnection - OSI security architecture ISO 7498-3 1980 Information processing systems - Open systems interconnection - Naming and addressing ISO 7498-4 1980 Information processing systems - Open systems interconnection - OSI management framework ISO 8601 1988 Data elements and i
38、nterchange formats - Information interchange - Representation of dates and times ISO 8649 Information technology - Open systems interconnection - Service definition for the Association Control Service Elements ISO/IEC 8650-1 Information technology - Open systems interconnection - Specification of pr
39、otocols for Common Application Service Elements - Part 1: Introduction 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 P1073.1.2.1/Draft 5c 6 ISO/IEEE
40、P11073-10201 2002-07-292003-05-01 Copyright 2003 IEEE and ISO. All rights reserved. 8 This is an unapproved IEEE and ISO Standards Draft, subject to change.ISO/IEC 8650-2 Information technology - Open systems interconnection - Specification of protocols for Common Application Service Elements - Part
41、 2: Association Protocol ISO/IEC 8824 1990 Information technology - Open systems interconnection - Specification of Abstract Syntax Notation One (ASN.1). ISO/IEC 9545 1989 Information processing systems - Open systems interconnection - Application layer structure (ALS) ISO/IEC 9595(E) 1991 Informati
42、on technology - Open systems interconnection - Common management information service (CMIS) definition ISO/IEC 10040 1992 Information technology - Open systems interconnection - Systems management overview ISO/IEC 10164-1(E) 1993 Information technology - Open systems interconnection - Systems manage
43、ment: Object management function ISO/IEC 10164-2(E) 1993 Information technology - Open systems interconnection - Systems management: State management function ISO/IEC 10164-3(E) 1993 Information technology - Open systems interconnection - System management: Attributes for representing relationships
44、ISO/IEC 10164-4(E) 1992 Information processing systems - Open systems interconnection - Systems management: Alarms reporting function ISO/IEC 10164-5(E) 1993 Information technology - Open systems interconnection - Systems management: Event report management function ISO/IEC 10164-6 1993 Information
45、technology - Open systems interconnection - Systems management: Log control function ISO/IEC 10164-7(E) 1992 Information technology - Open systems interconnection - Systems management: Security alarm reporting function ISO/IEC 10164-8(E) 1993 Information technology - Open systems interconnection - S
46、ystems management: Security audit trail function ISO/IEC 10164-9 1995 Information technology - Open systems interconnection - Systems management: Objects and attributes for access control ISO/IEC 10164-10 1995 Information technology - Open systems interconnection - Systems management: Accounting met
47、ering function ISO/IEC 10164-11 1994 Information technology - Open systems interconnection - Systems management: Workload monitoring function ISO/IEC 10164-12 1994 Information technology - Open systems interconnection - Systems management: Test management function ISO/IEC 10164-13 1995 Information t
48、echnology - Open systems interconnection - Systems management: Summarization function ISO/IEC 10164-14 1996 Information technology - Open systems interconnection - Systems management: Confidence and diagnostic test ISO/IEC 10165-1(E) 1993 Information processing systems - Open systems interconnection
49、 - Structure of management information: Management information model ISO/IEC 10165-2(E) 1992 Information processing systems - Open systems interconnection - Structure of management information: Definition of management information ISO/IEC 639 1988 Information technology - Open systems interconnection - Specification of Abstract Syntax Notation One (ASN.1). ISO/IEC 9545 Informatio