1、 IEC 60601-1-6Edition 3.0 2010-01INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral standard: Usability Appareils lectromdicaux Partie 1-6: Exigences gnrales pour la scurit de base et les perfor
2、mances essentielles Norme collatrale: Aptitude lutilisation IEC60601-1-6:2010 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2010 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electr
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16、ette 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 60601-1-6Edition 3.0 2010-01INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Part 1-6: General requirements for
17、 basic safety and essential performance Collateral standard: Usability Appareils lectromdicaux Partie 1-6: Exigences gnrales pour la scurit de base et les performances essentielles Norme collatrale: Aptitude lutilisation INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATI
18、ONALE UICS 11.040 PRICE CODECODE PRIXISBN 2-8318-1077-4 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale 2 60601-1-6 IEC:2010 CONTENTS FOREWORD.3 INTRODUCTION.6 1 Scope, object and related standards.7 1.1 * Scope .7 1
19、.2 Object .7 1.3 Related standards .7 1.3.1 IEC 60601-1 7 1.3.2 Particular standards 7 2 Normative references .7 3 Terms and definitions .8 4 General requirements.8 4.1 * Conditions for application to ME EQUIPMENT .8 4.2 * USABILITY ENGINEERING PROCESS for ME EQUIPMENT8 5 * Replacement of requiremen
20、ts given in IEC 62366 9 Annex A (informative) General guidance and rationale.10 Annex B (informative) Mapping between the elements of IEC 60601-1-6:2006 and the related elements in IEC 62366:2007 .12 Annex C (informative) References to items of USABILITY provided in IEC 62366:2007 and their use in o
21、ther standards19 Bibliography22 Index of defined terms used with this collateral standard 24 Table B.1 Mapping between the elements of IEC 60601-1-6:2006 and the related elements in IEC 62366:2007 .12 Table C.1 References to items of USABILITY in IEC 62366 and their use in other standards19 60601-1-
22、6 IEC:2010 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 1-6: General requirements for basic safety and essential performance Collateral standard: Usability FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardizati
23、on 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 electrical and electronic fields. To this end and in addition to other activities, IEC publishes Internation
24、al Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in th
25、is preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two
26、 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 committee has representation from all interested IEC National Committees. 3) IEC Publications have the
27、 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 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterp
28、retation 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 and regional publications. Any divergence between any IEC Publication and the corresponding national o
29、r regional publication shall be clearly indicated in the latter. 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carrie
30、d out by independent certification bodies. 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 Commi
31、ttees 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
32、 the Normative 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 h
33、eld responsible for identifying any or all such patent rights. International Standard IEC 60601-1-6 has been prepared by subcommittee 62A: Common aspects of electrical equipment used in medical practice, of IEC technical committee 62: Electrical equipment in medical practice. This third edition cons
34、titutes a collateral standard to IEC 60601-1: Medical electrical equipment Part 1: General requirements for basic safety and essential performance hereafter referred to as the general standard. This document cancels and replaces the second edition of IEC 60601-1-6 which has been technically revised.
35、 To allow for equipment manufacturers and testing organizations to make products and to equip themselves for conducting revised tests in accordance with this third edition, it is recommended by SC 62A that the content of this document not be adopted for mandatory implementation earlier than 3 years
36、from the date of publication for equipment newly designed and not earlier than 5 years from the date of publication for equipment already in production. 4 60601-1-6 IEC:2010 This edition of IEC 60601-1-6 was revised to align with the USABILITY ENGINEERING PROCESS in IEC 62366. The text of this stand
37、ard is based on the following documents: FDIS Report on voting 62A/682/FDIS 62A/689/RVDFull information on the voting for the approval of this standard can be found in the report on voting indicated in the above table. This publication has been drafted in accordance with the ISO/IEC Directives, Part
38、 2. In the IEC 60601 series of publications, 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 stan
39、dard (e.g. alarm systems). In this collateral standard, the following print types are used: Requirements and definitions: roman type. Test specifications or instructions to modify requirements in IEC 62366: italic type. Informative material appearing outside of tables, such as notes, examples and re
40、ferences: in smaller type. Normative text of tables is also in a smaller type. TERMS 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 numbered divisions within the
41、table of contents, inclusive of all subdivisions (e.g. Clause 4 includes subclauses 4.1, 4.2, etc.); “subclause” means a numbered subdivision of a clause (e.g. 4.1 and 4.2 are all subclauses of Clause 4). References to clauses within this standard are preceded by the term “Clause” followed by the cl
42、ause number. References to subclauses within this standard are by number 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
43、ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary 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
44、 with this standard; “may” is used to describe a permissible way to achieve 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 (*). 60601-1-6 IEC:2010 5 To assist the user of this collateral
45、standard in migrating from IEC 60601-1-6:2006 to IEC 62366:2007, Table B.1 has been developed. This table maps the clauses and subclause of IEC 60601-1-6:2006 to the comparable clauses and subclauses in IEC 62366:2007. To further assist the user of this collateral standard, Table C.1 relates certain
46、 elements of IEC 62366 to other standards, such as parts of the ISO 9241 series, which might be useful in meeting the requirements of IEC 62366. A list of all parts of the IEC 60601 series, under the general title: Medical electrical equipment, can be found on the IEC website. The committee has deci
47、ded 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 reconfirmed, withdrawn, replaced by a revised edition,
48、or amended. 6 60601-1-6 IEC:2010 INTRODUCTION Medical practice is increasingly using MEDICAL ELECTRICAL EQUIPMENT for observation and treatment of PATIENTS. USE ERRORS caused by inadequate MEDICAL ELECTRICAL EQUIPMENT USABILITY have become an increasing cause for concern. Much of ME EQUIPMENT develo
49、ped without applying a USABILITY ENGINEERING PROCESS are non-intuitive, difficult to learn and to use. As healthcare evolves, less skilled OPERATORS including PATIENTS themselves are now using MEDICAL ELECTRICAL EQUIPMENT while the MEDICAL ELECTRICAL EQUIPMENT itself is becoming more complicated. In simpler times, the OPERATOR of the MEDICAL ELECTRICAL EQUIPMENT might be able to co
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