1、ANSI/AAMI/IEC 80601-2-58:2014Medical electrical equipment Part 2-58: Particular requirements for basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgeryAmerican National StandardAmerican National Standard ANSI/AAMI/IEC 80601-2-58:2014 (Revision of ANSI/AA
2、MI/IEC 80601-2-58:2008) Medical electrical equipment Part 2-58: Particular requirements for basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery Approved 28 July 2014 by Association for the Advancement of Medical Instrumentation Approved 10 September 2
3、014 by American National Standards Institute, Inc. Abstract: The purpose of this standard is to set appropriate requirements for the safety and performance of lens removal and vitrectomy devices for ophthalmic surgery to reduce the risk of detrimental impact on the medical treatment to an acceptable
4、 level for their intended use. The benefit of this standard is to the medical industry, manufacturers, medical regulators, hospitals, clinics, medical users and finally to the patient. Keywords: electromedical equipment, safety, ophthalmology AAMI Standard This Association for the Advancement of Med
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9、horities, in which case the adopting agency is responsible for enforcement of its rules and regulations. Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2014 by the Association for the Advancement of Medic
10、al Instrumentation All Rights Reserved This publication is subject to copyright claims of ISO, ANSI, and AAMI. No part of this publication may be reproduced or distributed in any form, including an electronic retrieval system, without the prior written permission of AAMI. All requests pertaining to
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13、+1-703-525-4890; Fax: +1-703-525-1067. Printed in the United States of America ISBN 1-57020-562-0 Contents Page Glossary of equivalent standards . iv Committee representation . v Background of ANSI/AAMI adoption of IEC 80601-2-58:2014 vi Foreword . vii Introduction ix 201.1 Scope, object and related
14、 standards 1 201.2 Normative references 2 201.3 Terms and definitions 3 201.4 General requirements 5 201.5 General requirements for testing of ME EQUIPMENT .5201.6 Classification of ME EQUIPMENT and ME SYSTEMS 5 201.7 ME EQUIPMENT identification, marking and documents . 5 201.8 Protection against el
15、ectrical hazards from me equipment . 7 201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS 7 201.10 Protection against unwanted and excessive radiation hazards 7 201.11 Protection against excessive temperatures and other hazards . 7 201.12 Accuracy of controls and instruments
16、and protection against hazardous outputs 7 201.13 Hazardous situations and fault conditions for ME EQUIPMENT 16 201.14 Programmable electrical medical systems (PEMS) 16 201.15 Construction of ME EQUIPMENT 16 201.16 * ME SYSTEMS 16 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .
17、 16 202 Electromagnetic compatibility Requirements and tests 16 Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS . 18 Annex AA (informative) Particular guidance and rationale . 19 Bibliography . 21 Index of defined terms . 22 Glossary of equivalent st
18、andards International Standards adopted in the United States may include normative references to other International Standards. AAMI maintains a current list of each International Standard that has been adopted by AAMI (and ANSI). Available on the AAMI website at the address below, this list gives t
19、he corresponding U.S. designation and level of equivalency to the International Standard. www.aami.org/standards/glossary.pdf iv 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC 80601-2-58:2014 Committee representation Association for the Advancement of Medical Instrumen
20、tation EV/WG 13 - Lens removal and vitrectomy devices working group The adoption of IEC 80601-2-58 as a revision of ANSI/AAMI/IEC 80601-2-58:2008 was initiated by the AAMI Lens removal and vitrectomy devices working group, which serves as the U.S. TAG (technical advisory group) for IEC/SC 62D/JWG 13
21、. U.S. representatives played an active role in developing the IEC standard. Committee approval of the standard does not necessarily imply that all committee members voted for its approval. At the time this document was published, the AAMI Lens removal and vitrectomy devices Working Group had the fo
22、llowing members: Members: Steven T. Charles, Charles Retina Institute Evelyn De La Vega, Bausch 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 particip
23、ate in this preparation. IEC collaborates closely with the International Organization 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 in
24、ternational consensus of opinion on the relevant subjects since each technical 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 rea
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26、EC Publications transparently to the maximum extent possible in their national 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 itself does not provide any attestation of conf
27、ormity. Independent certification bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by independent certification bodies. 6) All users should ensure that they have the latest edition of this publica
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29、 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 Normative references cited in this publication. Use of the referenced publications is indispensable for the correc
30、t 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 responsible for identifying any or all such patent rights. International standard IEC 80601-2-58 has been prepared
31、by subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice, and subcommittee SC 7: Ophthalmic optics and instruments of ISO technical committee 172: Optics and photonics. This second edition cancels and replaces the first edition of IEC 806
32、01-2-58 published in 2008. It is published as a double logo standard. 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC 80601-2-58:2014 vii The text of this standard is based on the following documents: FDIS Report on voting 62D/1151/FDIS 62D/1161/RVD Full information on
33、the voting for the approval of this standard can be found in the report on voting indicated in the above table. In ISO, the standard has been approved by 12 P members out of 12 having cast a vote. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this standard,
34、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 DEFINED IN CLAUSE 3 OF
35、THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. In referring to the structure of this standard, the term “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.
36、); “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7). References to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this particular standard are by number only. I
37、n 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 auxiliary ve
38、rb: “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 achieve com
39、pliance with a requirement or test. An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA. A list of all parts of the IEC 60601 series, published under the general title Medic
40、al electrical equipment, can be found on the IEC website. The committee has decided that the contents of this publication will remain unchanged until the stability date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publ
41、ication will be reconfirmed, withdrawn, replaced by a revised edition, or amended. viii 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC 80601-2-58:2014 INTRODUCTION LENS REMOVAL DEVICES and VITRECTOMY DEVICES are used widely in ophthalmology to perform anterior-segment
42、and posterior-segment surgery on the human eye. Commercial use of these MEDICAL ELECTRICAL EQUIPMENT devices began in the early 1970s. This International Standard defines particular requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES, comprising an
43、equipment console, surgical HANDPIECES and ACCESSORIES connected to this ME EQUIPMENT. In many parts of the world LENS REMOVAL DEVICES and VITRECTOMY DEVICES are used in combination by ophthalmic surgeons to perform combined anterior-segment (lens removal) and posterior-segment (vitreoretinal) surgi
44、cal PROCEDURES to maximize surgical outcomes. For this reason both LENS REMOVAL DEVICES and VITRECTOMY DEVICES are covered in this International Standard. As all particular standards in the IEC 60601-1 series are based on the general standard IEC 60601-1, the user of this standard is reminded that R
45、ISK MANGEMENT plays an important role in the use of this particular standard. Compliance with the requirements of this particular standard should be documented in the RISK MANAGEMENT FILE to ensure the HAZARDS associated with the product have been considered fully. 2014 Association for the Advanceme
46、nt of Medical Instrumentation ANSI/AAMI/IEC 80601-2-58:2014 ix x 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC 80601-2-58:2014 MEDICAL ELECTRICAL EQUIPMENT Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vi
47、trectomy devices for ophthalmic surgery 201.1 Scope, object and related standards Clause 1 of the general standard1applies, except as follows: 201.1.1 * Scope Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES
48、 for ophthalmic surgery (as defined in 201.3.208 and 201.3.217) and associated ACCESSORIES that can be connected to this MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only
49、, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard. 201.1.2 Object Replacement: The object of this particular standard is to establish particular
