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1、 Recognized as an American National Standard (ANSI) The Institute of Electrical and Electronics Engineers, Inc. 345 East 47th Street, New York, NY 10017-2394, USA Copyright 1996 by the Institute of Electrical and Electronics Engineers, Inc. All rights reserved. Published 1996. Printed in the United
2、States of America. ISBN 1-55937-755-0 No part of this publication may be reproduced in any form, in an electronic retrieval system or otherwise, without the prior written permission of the publisher. IEEE Std 1073-1996 IEEE Standard for Medical Device CommunicationsOverview and Framework Sponsor Med
3、ical Information Bus (MIB) Committee of the IEEE Engineering in Medicine and Biology Society Approved 13 May 1996 IEEE Standards Board Approved 3 October 1996 American National Standards Institute Abstract: An overall definition of the IEEE 1073 family of standards is provided, describing the interc
4、onnection and interoperation of medical devices with computerized healthcare information systems in a manner suitable for the clinical environment. Keywords: acute care, bedside environment, computerized healthcare information systems, medical devices, medical device system (MDS), patient care infor
5、mation system, patient data man- agement system, virtual medical device (VMD). IEEE Standards documents are developed within the IEEE Societies and the Standards Coordinat- ing Committees of the IEEE Standards Board. Members of the committees serve voluntarily and without compensation. They are not
6、necessarily members of the Institute. The standards developed within IEEE represent a consensus of the broad expertise on the subject within the Institute as well as those activities outside of IEEE that have expressed an interest in participating in the develop- ment of the standard. Use of an IEEE
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8、oved and issued is subject to change brought about through developments in the state of the art and comments received from users of the standard. Every IEEE Standard is sub- jected to review at least every fi ve years for revision or reaffi rmation. When a document is more than fi ve years old and h
9、as not been reaffi rmed, it is reasonable to conclude that its contents, although still of some value, do not wholly refl ect the present state of the art. Users are cautioned to check to determine that they have the latest edition of any IEEE Standard. Comments for revision of IEEE Standards are we
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15、Permission to photocopy portions of any individual standard for educational class- room use can also be obtained through the Copyright Clearance Center. Note: Attention is called to the possibility that implementation of this standard may require use of subject matter covered by patent rights. By pu
16、blication of this standard, no position is taken with respect to the existence or validity of any patent rights in connection therewith. The IEEE shall not be responsible for identifying all patents for which a license may be required by an IEEE standard or for conducting inquiries into the legal va
17、lidity or scope of those patents that are brought to its attention. iii Introduction (This introduction is not part of IEEE Std 1073-1996, IEEE Standard for Medical Device CommunicationsOverview and Framework.) This standard for medical device communications defi nes a family of standards for provid
18、ing interconnec- tion and interoperability of medical devices and computerized healthcare information systems. Medical devices include a broad range of clinical monitoring, diagnostic, and therapeutic equipment. Computerized healthcare information systems similarly include a broad range of clinical
19、data management systems, patient care systems, and hospital information systems. This family of standards is fi rmly based on international standards for open systems communications and on the base layer standards and standardized profi les for the actual protocols and services specifi ed. This docu
20、ment is the top-level document in the family of documents comprising the IEEE 1073 family of standards. It is intended to provide the reader with an overview of the concept of medical device communi- cations applied in this family of standards, as well as to provide a roadmap to the other documents
21、in the family. While complete references are provided to international documents where appropriate, the reader will greatly benefi t from a familiarity with the International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC) documents for computer communicati
22、on protocols, and particularly their basic reference model for Open Systems Interconnection (OSI) and related service and pro- tocol defi nitions. Many people participated in the development of this document over the history of the working group, and the contributors are listed as follows: Robert Ke
23、nnelly , Chair John J. Harrington, Technical Editor Phil Bartleson Jeff Becker Ken Beckman George Beeler Glenn Bell Scott Bradley Charles Brill Jim Busenius Ben Cammack William Chamberlin Vivian Coates Bill Coleman Richard Cook Luc De Keyser Don Eddleman Yossi Elaz James Elf Al Figler Daniel Fink Pa
24、ul Fitzmeyer Dan Frank David Franklin Kenneth Fuchs William Furniss Reed Gardner Mark Geisler Sam Ginburg Mike Glass Joel Gochberg Helen Gottschalk Bill Hawley John Hoffman Stanley Huff Paul Hufnagel Rick Hulett Constance Kelly Colleen McGough Royal Morse Katherine Nichols Lorene Nolan Ron Norden-Pa
25、ul David Ostler Barbara Paganelli Kim Pemble Mark Poler Vince Price Jim Pritulsky James Quigley Mike Repucci Gary Ruggeiro Tom Rutt Dave Sanford Niilo Saranummi John Schaar Michael Shabot Glen Sherwood Dan Shia Dave Shultz Simon Smith Andrew Spector Mike Spicer Stanley Stead Jeff Taylor Wayne Tracy
26、Douglas Tucker Charlie Turini Clifford Weber Chris White Weldon White Jos. Willems Jan Wittenber Jonathan Woods John Zelcer Dale Zeskind iv The following persons were on the balloting committee: The fi nal conditions for approval of this standard were met on 13 May 1996. This standard was conditiona
27、lly approved by the IEEE Standards Board on 21 March 1996, with the following membership: Donald C. Loughry, Chair Richard J. Holleman, Vice Chair Andrew G. Salem, Secretary *Member Emeritus Also included are the following nonvoting IEEE Standards Board liaisons: Satish K. Aggarwal Alan H. Cookson C
28、hester C. Taylor Kristin M. Dittmann IEEE Standards Project Editor Joost Ansems Henry Benoit Tim Benson Pietropaolo Bianchi Charles Brill Greg Cinque Bruce Cloutier Todd Cooper James Cudney Phil Curran Gary Dickinson Don Eddleman Grace Esche Peter Felleiter Alan Figler Michael Floetotto Janie Fouke
29、David Franklin Kenneth Fuchs James Gaston Wolfgang Giere Mike Glass Helen Gottschalk Doug Hakala Ed Hammond John Harrington Bill Hawley Joerg Hoehne Earl Hoerner Stanley Huff Michael Imhoff Glen Johnson Michael Joseph Jorg Kampmann Constance Kelly Robert Kennelly Jorgen Kilden-Pedersen Jim Klein Ran
30、dall Krohn Daniel MacNeil David Mandelstam Gerald Masek Clement McDonald Jim McGrath Hubert Mensch Katherine Nichols Mike Norton Paul Oehler Henrik Olesen Helmuth Orthner Mark Poler G. Rau Rick Robeson Anders Rorholt Paul Rubel Ricardo Ruiz Paul Rummel Carlos Salvador John Santell Nillo Saranummi Mi
31、chael Shabot Dan Shia Jack Sippel Andrew Spector Michael Spicer Jan Stanek Stanley Stead P. Stegmaier Helmut Thiemann Anders Thurin Wayne Tracy Charlie Turini Clifford Weber Adreas Weser Lawrence Widman Mark Williams Shu-Jen Yeh Dale Zeskind Gilles A. Baril Clyde R. Camp Joseph A. Cannatelli Stephen
32、 L. Diamond Harold E. Epstein Donald C. Fleckenstein Jay Forster* Donald N. Heirman Ben C. Johnson E. G. “Al” Kiener Joseph L. Koepfi nger* Stephen R. Lambert Lawrence V. McCall L. Bruce McClung Marco W. Migliaro Mary Lou Padgett John W. Pope Jose R. Ramos Arthur K. Reilly Ronald H. Reimer Gary S. R
33、obinson Ingo Rsch John S. Ryan Chee Kiow Tan Leonard L. Tripp Howard L. Wolfman v Contents CLAUSEPAGE 1.Overview 1 1.1 Scope 1 1.2 Purpose. 1 1.3 Key requirements. 1 1.4 Application and support. 2 1.5 Family of standards 3 2.References 3 3.Definitions 4 4.Acronymns and abbreviations 5 5.Conformance
34、5 6.Conceptual model 6 6.1 Introduction 6 6.2 Bedside environment . 6 6.3 Virtual medical device (VMD) 7 6.4 Medical device data language (MDDL) 7 6.5 Communications controllers 8 7.Information model . 9 8.Communications model. 9 8.1 Introduction 9 8.2 Reference model (RM) 9 8.3 Implementation model
35、 (IM). 10 ANNEX Annex A(informative) Current IEEE 1073 standard profiles and base layer standards. 13 Annex B(informative) Interoperable profile stacks . 14 Annex C(normative) User requirements 17 Annex D(normative) Allocation of identifiers. 18 vi 1 IEEE Standard for Medical Device CommunicationsOv
36、erview and Framework 1. Overview 1.1 Scope The scope of this family of standards is to provide for open systems communications in healthcare applications, primarily between bedside medical devices and patient care information systems, optimized for the acute care setting. The scope of this document
37、is to provide the overall definition of the family of standards. It does so by defining a conceptual model, an information model, and a communications model for medical device communications and by specifying constraints for conformance to the set of standards. 1.2 Purpose The purpose of the family
38、of standards is to allow hospitals and other healthcare providers to allow medical instrumentation to interface with computerized healthcare information systems in a manner that is compatible with the acute care environment. The purpose of this document is to define the overall architecture for comm
39、unications between medical devices and host computers and to provide a roadmap to the overall family of standards. This document defines certain logical and functional entities, and as such no particular implementation is implied by this standard. 1.3 Key requirements This standard is intended to en
40、able medical devices to interconnect and interoperate with computerized healthcare information systems in a manner suitable for the clinical environment. The communications network described by this standard is distinguished from other types of conventional local area networks (LANs) in that it is o
41、ptimized for the acute patient care setting. This context imposes several key require- ments in the areas of reliability, network configuration, support for frequently changing host computer topologies, patient safety, and interface to healthcare personnel. IEEE Std 1073-1996IEEE STANDARD FOR MEDICA
42、L DEVICE COMMUNICATIONS 2 The key requirements are that this standard shall a) Meet applicable requirements for patient and user safety of medical devices. b) Accommodate frequent network reconfiguration. c) Provide an extremely simple user interface, the only required user action being to connect t
43、he medical device to the network. d) Unambiguously associate a medical device with a specific patient or bed. e) Support a wide range of host computer topologies, allowing implementations ranging from those limited to a single bedside to those that span multiple beds and care units, with various gra
44、dations between these extremes. f) Minimize implementation complexity for high-volume medical devices. The survey data used to compile this list of requirements is provided in annex C of this standard. Note that this standard defines certain optional services that may be used for device control oper
45、ations. The choice to use or not to use these services is outside the scope of this standard. 1.4 Application and support The scope of this standard does not preclude the use of the standard for domains that are outside of its scope. It is not the intent to define the requirements for, nor to optimi
46、ze the standard for, those domains outside of its scope. It is intended to have wide application within the healthcare industry for the area of medical device communications. The following paragraphs in this clause are intended to show potential applications and devices, but are not intended to be e
47、xhaustive, nor do they constitute a set of required items. This standard is designed for use in, but not limited to, the following illustrative examples: a) Automation of the recording and entry of information from electronic medical devices b) Providing clinical personnel access to device status ch
48、anges (e.g., alarms) c) Automation of adjustments of device settings derived from computed parameters Medical devices vary greatly in the nature of the data they report. Devices of current clinical engineering technology broadly range from simple devices to intelligent devices. Simple devices genera
49、lly only know about a single or small set of simple sensor readings. In particular, they know very little of the context of the data (e.g., units of measure, site, or method of measurement, etc.). Intelligent devices know a rela- tively large amount of information about the data and can provide much of the context of the data on demand. In addition to providing a standard for reliable transport of messages, this standard also provides for consistent syntax and semantics of those messages. Examples of devices that might be interfaced via this standard include, but are not limited to, a)
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