1、 IEC 60601-1-10Edition 1.0 2007-11INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Part 1-10: General requirements for basic safety and essential performance Collateral Standard: Requirements for the development of physiologicclosed-loop controllers Appareils lectromdicaux Par
2、tie 1-10: Exigences gnrales pour la scurit de base et les performances essentielles Norme collatrale: Exigences pour le dveloppement des rgulateurs physiologiques en boucle ferme IEC60601-1-10:2007 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2007 IEC, Geneva, Switzerland All rights reserved. U
3、nless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IEC or IECs member National Committee in the country of the requester. If you ha
4、ve any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or your local IEC member National Committee for further information. Droits de reproduction rservs. Sauf indication contraire, aucune partie de cette public
5、ation ne peut tre reproduite ni utilise sous quelque forme que ce soit et par aucun procd, lectronique ou mcanique, y compris la photocopie et les microfilms, sans laccord crit de la CEI ou du Comit national de la CEI du pays du demandeur. Si vous avez des questions sur le copyright de la CEI ou si
6、vous dsirez obtenir des droits supplmentaires sur cette publication, utilisez les coordonnes ci-aprs ou contactez le Comit national de la CEI de votre pays de rsidence. IEC Central Office 3, rue de Varemb CH-1211 Geneva 20 Switzerland Email: inmailiec.ch Web: www.iec.ch About the IEC The Internation
7、al Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes International Standards for all electrical, electronic and related technologies. About IEC publications The technical content of IEC publications is kept under constant review by the IEC. Please make
8、sure that you have the latest edition, a corrigenda or an amendment might have been published. Catalogue of IEC publications: www.iec.ch/searchpub The IEC on-line Catalogue enables you to search by a variety of criteria (reference number, text, technical committee,). It also gives information on pro
9、jects, withdrawn and replaced publications. IEC Just Published: www.iec.ch/online_news/justpub Stay up to date on all new IEC publications. Just Published details twice a month all new publications released. Available on-line and also by email. Electropedia: www.electropedia.org The worlds leading o
10、nline dictionary of electronic and electrical terms containing more than 20 000 terms and definitions in English and French, with equivalent terms in additional languages. Also known as the International Electrotechnical Vocabulary online. Customer Service Centre: www.iec.ch/webstore/custserv If you
11、 wish to give us your feedback on this publication or need further assistance, please visit the Customer Service Centre FAQ or contact us: Email: csciec.ch Tel.: +41 22 919 02 11 Fax: +41 22 919 03 00 A propos de la CEI La Commission Electrotechnique Internationale (CEI) est la premire organisation
12、mondiale qui labore et publie des normes internationales pour tout ce qui a trait llectricit, llectronique et aux technologies apparentes. A propos des publications CEI Le contenu technique des publications de la CEI est constamment revu. Veuillez vous assurer que vous possdez ldition la plus rcente
13、, un corrigendum ou amendement peut avoir t publi. Catalogue des publications de la CEI: www.iec.ch/searchpub/cur_fut-f.htm Le Catalogue en-ligne de la CEI vous permet deffectuer des recherches en utilisant diffrents critres (numro de rfrence, texte, comit dtudes,). Il donne aussi des informations s
14、ur les projets et les publications retires ou remplaces. Just Published CEI: www.iec.ch/online_news/justpub Restez inform sur les nouvelles publications de la CEI. Just Published dtaille deux fois par mois les nouvelles publications parues. Disponible en-ligne et aussi par email. Electropedia: www.e
15、lectropedia.org Le premier dictionnaire en ligne au monde de termes lectroniques et lectriques. Il contient plus de 20 000 termes et dfinitions en anglais et en franais, ainsi que les termes quivalents dans les langues additionnelles. Egalement appel Vocabulaire Electrotechnique International en lig
16、ne. Service Clients: www.iec.ch/webstore/custserv/custserv_entry-f.htm Si vous dsirez nous donner des commentaires sur cette publication ou si vous avez des questions, visitez le FAQ du Service clients ou contactez-nous: Email: csciec.ch Tl.: +41 22 919 02 11 Fax: +41 22 919 03 00 IEC 60601-1-10Edit
17、ion 1.0 2007-11INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Part 1-10: General requirements for basic safety and essential performance Collateral Standard: Requirements for the development of physiologicclosed-loop controllers Appareils lectromdicaux Partie 1-10: Exigences
18、 gnrales pour la scurit de base et les performances essentielles Norme collatrale: Exigences pour le dveloppement des rgulateurs physiologiques en boucle ferme INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE WICS 11.040 PRICE CODECODE PRIXISBN 2-8318-9448-4 2 606
19、01-1-10 IEC:2007 CONTENTS FOREWORD.4 INTRODUCTION.7 1 Scope, object and related standards.8 1.1 * Scope .8 1.2 Object .8 1.3 Related standards .8 1.3.1 IEC 60601-1 8 1.3.2 Particular standards 9 2 Normative references .9 3 Terms and definitions .9 4 * General requirements 14 5 ME EQUIPMENT identific
20、ation, marking and documents .14 5.1 * Instructions for use .14 5.2 Technical description.15 6 Accuracy of controls and instruments and protection against hazardous outputs 15 6.1 * USABILITY 15 6.2 ALARM SYSTEMS .15 6.3 * PCLCS VARIABLE logging 15 6.4 * DISTRIBUTED PCLCS 16 7 * PROGRAMMABLE ELECTRI
21、CAL MEDICAL SYSTEMS (PEMS) 16 8 Requirements for PHYSIOLOGIC CLOSED-LOOP CONTROLLER (PCLC) development16 8.1 * General.16 8.2 Attributes/activities of the PCLC development PROCESS .17 8.2.1 RECORDS and PROCESS scaling 17 8.2.2 Equipment specifications .17 8.2.3 * Disturbance management20 8.2.4 * PCL
22、C VERIFICATION.21 8.2.5 * PCLCS VALIDATION 21 Annex A (informative) General guidance and rationale.22 Annex B (informative) Description of dynamic performance of a PCLCS 32 Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS36 Bibliography37 Index of def
23、ined terms used in this collateral standard38 Figure 1 Functional diagram indicating typical components of a PHYSIOLOGIC CLOSED-LOOP CONTROL SYSTEM (PCLCS) utilizing a PCLC 10 Figure B.1 Example of PCLCS dynamic performance with no STEADY-STATE DEVIATION33 Figure B.2 Example of PCLCS dynamic perform
24、ance with STEADY-STATE DEVIATION.34 Figure B.3 Example of PCLCS dynamic performance transient COMMAND VARIABLE.35 60601-1-10 IEC:2007 3 Table A.1 Examples of ME EQUIPMENT or ME SYSTEMS that incorporate a PCLCS .22 Table C.2 ACCOMPANYING DOCUMENTS, instructions for use.36 Table C.3 ACCOMPANYING DOCUM
25、ENTS, technical description 36 4 60601-1-10 IEC:2007 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 1-10: General requirements for basic safety and essential performance Collateral Standard: Requirements for the development of physiologic closed-loop controllers FOREWO
26、RD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the elect
27、rical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to tech
28、nical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organ
29、ization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical
30、 committee has representation from all interested IEC National Committees. 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publicati
31、ons is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national
32、 and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment declared to be in
33、 conformity with an IEC Publication. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees
34、for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications. 8) Attention is drawn to the N
35、ormative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held re
36、sponsible for identifying any or all such patent rights. International standard IEC 60601-1-10 has been prepared by IEC subcommittee 62A: Common aspects of electrical equipment used in medical practice, of IEC technical committee 62: Electrical equipment in medical practice, and ISO subcommittees SC
37、1: Breathing attachments and anaesthetic machines, and SC3: Lung ventilators and related devices of ISO technical committee 121: Anaesthetic and respiratory equipment. It is published as double logo standard. This first edition constitutes a collateral standard to IEC 60601-1: Medical electrical equ
38、ipment Part 1: General requirements for safety and essential performance hereafter referred to as the general standard. 60601-1-10 IEC:2007 5 The text of this collateral standard is based on the following documents: FDIS Report on voting 62A/576/FDIS 62A/585/RVDFull information on the voting for the
39、 approval of this collateral standard can be found in the report on voting indicated in the above table. In ISO, the standard has been approved by 18 P-members out of 19 having cast a vote. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In the 60601 series of pu
40、blications, collateral standards specify general requirements for safety applicable to: a subgroup of MEDICAL ELECTRICAL EQUIPMENT (e.g. radiological equipment); or a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT, not fully addressed in the general standard (e.g. ALARM SYSTEMS). In thi
41、s collateral standard, the following print types are used: requirements and definitions: roman type. test specifications: italic type. informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type. TERMS
42、DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS COLLATERAL STANDARD OR AS NOTED: SMALL CAPITALS. In referring to the structure of this standard, the term “clause” means one of the eight numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 8 includes Subcla
43、uses 8.1, 8.2, etc.); “subclause” means a numbered subdivision of a clause (e.g. 8.1, 8.2 and 8.2.1 are all subclauses of Clause 8). References to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this standard are by number
44、 only. In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxil
45、iary verb: “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard; “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; “may” is used to describe a permissible way to achi
46、eve compliance with a requirement or test. Clauses, subclauses and definitions for which a rationale is provided in informative Annex A are marked with an asterisk (*). A list of all parts of the IEC 60601 series, published under the general title: Medical electrical equipment, can be found on the I
47、EC website. 6 60601-1-10 IEC:2007 The committee has decided that the contents of this publication will remain unchanged until the maintenance result date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be
48、 reconfirmed; withdrawn; replaced by a revised edition, or amended 60601-1-10 IEC:2007 7 INTRODUCTION The use of PHYSIOLOGIC CLOSED-LOOP CONTROLLERS in ME EQUIPMENT and ME SYSTEMS are expected to provide a successful strategy to improve PATIENT safety and reduce healthcare costs 910111213 1). New RI
49、SKS that are not directly addressed by previous standards are emerging in the development of this equipment. MANUFACTURERS employ a variety of methods to validate the safety and integrity of control systems with varying degrees of success. Classical methods of software VALIDATION for PHYSIOLOGIC CLOSED-LOOP CONTROLLERS can be insufficient to ensure performance wit
