1、ANSI/AAMI/IEC 80601-2-58:2014/A1:2016Amendment 1 to Medical electrical equipmentPart 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgeryAmerican National StandardObjectives and uses of AAMI standards and r
2、ecommended practices It is most important that the objectives and potential uses of an AAMI product standard or recommended practice are clearly understood. The objectives of AAMIs technical development program derive from AAMIs overall mission: the advancement of medical instrumentation. Essential
3、to such advancement are (1) a continued increase in the safe and effective application of current technologies to patient care, and (2) the encouragement of new technologies. It is AAMIs view that standards and recommended practices can contribute significantly to the advancement of medical instrume
4、ntation, provided that they are drafted with attention to these objectives and provided that arbitrary and restrictive uses are avoided. A voluntary standard for a medical device recommends to the manufacturer the information that should be provided with or on the product, basic safety and performan
5、ce criteria that should be considered in qualifying the device for clinical use, and the measurement techniques that can be used to determine whether the device conforms with the safety and performance criteria and/or to compare the performance characteristics of different products. Some standards e
6、mphasize the information that should be provided with the device, including performance characteristics, instructions for use, warnings and precautions, and other data considered important in ensuring the safe and effective use of the device in the clinical environment. Recommending the disclosure o
7、f performance characteristics often necessitates the development of specialized test methods to facilitate uniformity in reporting; reaching consensus on these tests can represent a considerable part of committee work. When a drafting committee determines that clinical concerns warrant the establish
8、ment of minimum safety and performance criteria, referee tests must be provided and the reasons for establishing the criteria must be documented in the rationale. A recommended practice provides guidelines for the use, care, and/or processing of a medical device or system. A recommended practice doe
9、s not address device performance per se, but rather procedures and practices that will help ensure that a device is used safely and effectively and that its performance will be maintained. Although a device standard is primarily directed to the manufacturer, it may also be of value to the potential
10、purchaser or user of the device as a frame of reference for device evaluation. Similarly, even though a recommended practice is usually oriented towards healthcare professionals, it may be useful to the manufacturer in better understanding the environment in which a medical device will be used. Also
11、, some recommended practices, while not addressing device performance criteria, provide guidelines to industrial personnel on such subjects as sterilization processing, methods of collecting data to establish safety and efficacy, human engineering, and other processing or evaluation techniques; such
12、 guidelines may be useful to health care professionals in understanding industrial practices. In determining whether an AAMI standard or recommended practice is relevant to the specific needs of a potential user of the document, several important concepts must be recognized: All AAMI standards and r
13、ecommended practices are voluntary (unless, of course, they are adopted by government regulatory or procurement authorities). The application of a standard or recommended practice is solely within the discretion and professional judgment of the user of the document. Each AAMI standard or recommended
14、 practice reflects the collective expertise of a committee of health care professionals and industrial representatives, whose work has been reviewed nationally (and sometimes internationally). As such, the consensus recommendations embodied in a standard or recommended practice are intended to respo
15、nd to clinical needs and, ultimately, to help ensure patient safety. A standard or recommended practice is limited, however, in the sense that it responds generally to perceived risks and conditions that may not always be relevant to specific situations. A standard or recommended practice is an impo
16、rtant reference in responsible decision-making, but it should never replace responsible decision-making. Despite periodic review and revision (at least once every five years), a standard or recommended practice is necessarily a static document applied to a dynamic technology. Therefore, a standards
17、user must carefully review the reasons why the document was initially developed and the specific rationale for each of its provisions. This review will reveal whether the document remains relevant to the specific needs of the user. Particular care should be taken in applying a product standard to ex
18、isting devices and equipment, and in applying a recommended practice to current procedures and practices. While observed or potential risks with existing equipment typically form the basis for the safety and performance criteria defined in a standard, professional judgment must be used in applying t
19、hese criteria to existing equipment. No single source of information will serve to identify a particular product as “unsafe“. A voluntary standard can be used as one resource, but the ultimate decision as to product safety and efficacy must take into account the specifics of its utilization and, of
20、course, cost-benefit considerations. Similarly, a recommended practice should be analyzed in the context of the specific needs and resources of the individual institution or firm. Again, the rationale accompanying each AAMI standard and recommended practice is an excellent guide to the reasoning and
21、 data underlying its provision. In summary, a standard or recommended practice is truly useful only when it is used in conjunction with other sources of information and policy guidance and in the context of professional experience and judgment. INTERPRETATIONS OF AAMI STANDARDS AND RECOMMENDED PRACT
22、ICES Requests for interpretations of AAMI standards and recommended practices must be made in writing, to the AAMI Vice President, Standards Policy and Programs. An official interpretation must be approved by letter ballot of the originating committee and subsequently reviewed and approved by the AA
23、MI Standards Board. The interpretation will become official and representation of the Association only upon exhaustion of any appeals and upon publication of notice of interpretation in the “Standards Monitor“ section of the AAMI News. The Association for the Advancement of Medical Instrumentation d
24、isclaims responsibility for any characterization or explanation of a standard or recommended practice which has not been developed and communicated in accordance with this procedure and which is not published, by appropriate notice, as an official interpretation in the AAMI News. American National S
25、tandard ANSI/AAMI/IEC 80601-2-58:2014/A1:2016 (Amendment 1 to ANSI/AAMI/IEC 80601-2-58:2014) Amendment 1 to Medical electrical equipmentPart 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery Approved 7 O
26、ctober 2016 by AAMI Approved 27 December 2016 by American National Standards Institute, Inc. Abstract: Modifies the content of the second edition of IEC 80601-2-58 and includes an integration of updated definition of essential performance and updating the essential performance analysis, removing the
27、 dates of collateral and general standard references, addition of symbols, and updating of EMC requirements. Keywords: electromedical equipment, safety, ophthalmology AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substantia
28、lly concerned with its scope and provisions. The existence of an AAMI standard does not in any respect preclude anyone, whether they have approved the standard or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the standard. AAMI standard
29、s are subject to periodic review, and users are cautioned to obtain the latest editions. CAUTION NOTICE: This AAMI standard may be revised or withdrawn at any time. AAMI procedures require that action be taken to reaffirm, revise, or withdraw this standard no later than five years from the date of p
30、ublication. Interested parties may obtain current information on all AAMI standards by calling or writing AAMI, or by visiting the AAMI website at www.aami.org. All AAMI standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI are volu
31、ntary, and their application is solely within the discretion and professional judgment of the user of the document. Occasionally, voluntary technical documents are adopted by government regulatory agencies or procurement authorities, in which case the adopting agency is responsible for enforcement o
32、f its rules and regulations. Published by AAMI 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2017 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of ISO and AAMI. No part of this publicatio
33、n may be reproduced or distributed in any form, including an electronic retrieval system, without the prior written permission of AAMI. All requests pertaining to this document should be submitted to AAMI. It is illegal under federal law (17 U.S.C. 101, et seq.) to make copies of all or any part of
34、this document (whether internally or externally) without the prior written permission of the Association for the Advancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, and damages of $100,000 per offense. For permission regarding the use of all o
35、r any part of this document, complete the reprint request form at www.aami.org or contact AAMI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-276-0793. Printed in the United States of America ISBN 978-1-57020-650-4 Contents Page Glossary of equivalen
36、t standards iv Committee representation . v Background of ANSI/AAMI adoption of Amendment 1 to IEC 80601-2-58:2014 . vi Foreword . vii Introduction to the Amendment 1 201.1.3 Collateral standards . 1 201.1.3 * Collateral standards 1 201.1.4 Particular standards . 1 201.2 Normative references 1 201.7
37、 ME EQUIPMENT identification, marking and documents . 2 201.7.6.101* Additional symbols 2 201.7.9.2.12 Cleaning, disinfection, and sterilization 2 201.11.6.7 Sterilization of ME EQUIPMENT and ME SYSTEMS . 2 201.12.1.101.7 Accuracy of ultrasonic velocity of TIP 2 201.12.1.101.8 Accuracy of velocity o
38、f fluid entering eye for LIQUEFACTION . 2 201.13 Hazardous situations and fault conditions for ME EQUIPMENT . 3 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 3 202 Electromagnetic compatibility Requirements and tests 3 202 Electromagnetic disturbances Requirements and tests 3 2
39、02.5.2.2.2 * Requirements applicable to ME EQUIPMENT and ME SYSTEMS specified for use only in a shielded location SPECIAL ENVIRONMENT 3 202.5.2.2.4 Requirements applicable to ME EQUIPMENT that includes RF transmitters 3 202.7 ELECTROMAGNETIC EMISSIONS requirements for ME EQUIPMENT and ME SYSTEMS 3 2
40、02.7.1.2 Operating modes 3 202.8 Electromagnetic IMMUNITY requirements for ME EQUIPMENT and ME SYSTEMS 3 202.8.1* General . 3 Annexes 3 Annex D (informative) Symbols on marking (See Clause 7) 4 Annex AA (informative) Particular guidance and rationale. 5 A.A.2 Rationale for particular clauses and sub
41、clauses 5 Subclause 201.1.3 Collateral standards 5 Subclause 201.4.3 ESSENTIAL PERFORMANCE . 5 Subclause 201.4.101 Additional functions . 6 Subclause 201.7.6.101 Additional symbols . 6 Clause 201.16 ME SYSTEMS . 7 Subclause 202.5.2.2.2 Requirements applicable to ME EQUIPMENT and ME SYSTEMS specified
42、 for use only in a shielded location SPECIAL ENVIRONMENT 7 Subclause 202.8.1 General 7 Bibliography 8 Index of defined terms . 9 iv 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC 80601-2-58:2014/A1:2016 Glossary of equivalent standards International Standards adopted i
43、n 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 the corresponding U.S. designation and lev
44、el of equivalency to the International Standard. www.aami.org/standards/glossary.pdf 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC 80601-2-58:2014/A1:2016 v Committee representation Association for the Advancement of Medical Instrumentation Lens Removal and Vitrectomy
45、 Devices Working Group The adoption of Amendment 1 to IEC 80601-2-58 as an amendment to an existing national standard, ANSI/AAM/IEC 80601-2-58:2014 was initiated by the AAMI Lens Removal and Vitrectomy Devices Working Group. U.S. representatives played an active role in developing the IEC standard.
46、Committee approval of the standard does not necessarily imply that all committee members voted for its approval. At the time this document was published, AAMI Lens Removal and Vitrectomy Devices Working Group had the following members: Members: Alternates: Steven Charles, Charles Retina Institute Ev
47、elyn De La Vega, Bausch b) undating collateral and general standard references to align with amendments to the general standard and other collateral standards; c) addition of symbols to standard; d) update of EMC requirements. _ 201.1.3 Collateral standards Replace the existing title of this subclau
48、se by the following new title: 201.1.3 * Collateral standards Replace the existing text of the second paragraph by the following: IEC 60601-1-2 applies as modified in Clause 202. IEC 60601-1-3, IEC 60601-1-10, IEC 60601-1-11, and IEC 60601-1-12 do not apply. 201.1.4 Particular standards Add, in the
49、fourth paragraph of the subclause, “IEC“ before the existing references to “60601-1-2“ and “60601-1-3“. Add, in the second sentence of the eight paragraph of the subclause, a comma immediately after “However”. 201.2 Normative references Delete the second footnote of the standard. Replace the existing reference to IEC 60601-1-2, by the following new reference: IEC 60601-1-2, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic disturbances Requirements and te
