1、Association for the Advancement of Medical Instrumentationwww.aami.orgISBN 1-57020-246-XANSI/AAMI ES 60601-1:2005/(R)2012 reaching consensus on these tests can represent a considerable part of committee work. When a drafting committee determines that clinical concerns warrant the establishment of mi
2、nimum 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 does not addr
3、ess 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 purchaser
4、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, some rec
5、ommended 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 guideline
6、s 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 recommended
7、 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 practice
8、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 respond to clin
9、ical 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 important refe
10、rence 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 user must
11、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 existing dev
12、ices 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 these crite
13、ria 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 course, co
14、st-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 data unde
15、rlying 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 PRACTICES Reque
16、sts 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 AAMI Standar
17、ds 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 disclaims r
18、esponsibility 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 Standard AN
19、SI/AAMI ES60601-1:2005/(R):2012 and ANSI/AAMI ES60601-1:2005/A1:2012 and ANSI/AAMI ES60601-1:2005/C1:2009/(R)2012 and ANSI/AAMI ES60601-1:2005/A2:2010/(R)2012 (Consolidated text) (IEC 60601-1:2005, MOD) Medical electrical equipment Part 1: General requirements for basic safety and essential performa
20、nce Developed by Association for the Advancement of Medical Instrumentation Approved 9 February 2006 and reaffirmed 17 January 2012 by Amendment A1 approved 21 August 2012 by Amendment C1 approved 20 November 2009 and reaffirmed 17 January 2012 by Amendment A2 approved 20 April 2010 and reaffirmed 1
21、7 January 2012 by American National Standards Institute, Inc. Abstract: Baseline of requirements for the basic safety and essential performance of all medical electrical equipment used by or under the supervision of qualified personnel in the general medical and patient environment. Also contains ce
22、rtain requirements for reliable operation to ensure safety. This standard can also be applied to equipment used for compensation or alleviation of disease, injury, or disability. This consolidates the original text of ANSI/AAMI ES60601-1:2005 and its amendments. Keywords: electromedical equipment, e
23、lectrical safety, essential performance AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substantially concerned with its scope and provisions. The existence of an AAMI standard does not in any respect preclude anyone, whether
24、 they have approved the standard or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the standard. AAMI standards are subject to periodic review, and users are cautioned to obtain the latest editions. CAUTION NOTICE: This AAMI standard may
25、 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 publication. Interested parties may obtain current information on all AAMI standards by calling or writing AAMI, or by visiting
26、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 voluntary, and their application is solely within the discretion and professional judgment of the user of the document. Occasionall
27、y, voluntary technical documents are adopted by government regulatory agencies or procurement authorities, 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, Sui
28、te 301 Arlington, VA 22203-1633 www.aami.org 2013 by the Association for the Advancement of Medical 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 elect
29、ronic 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 this document (whether internally or externally) without the prior
30、 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 or any part of this document, complete the reprint request form at
31、www.aami.org or contact AAMI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-525-1067. Printed in the United States of America ISBN 157020246X CONTENTS Glossary of equivalent standards . xii Committee representation . xiii Background of AAMI adoption
32、of IEC 60601-1:2005 and Amendment 1.xiv AAMI deviations from IEC 60601-1:2005 xv FOREWORD . xviii INTRODUCTION xxi INTRODUCTION TO THE AMENDMENT . xxiii 1 Scope, object and related standards . 1 1.1 * Scope 1 1.2 Object 1 1.3 * Collateral standards. 2 1.4 * Particular standards. 2 2 * Normative refe
33、rences . 2 3 * Terminology and definitions 6 4 General requirements 27 4.1 * Conditions for application to ME EQUIPMENT or ME SYSTEMS . 27 4.2 * RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS . 27 4.3 * ESSENTIAL PERFORMANCE 30 4.4 * EXPECTED SERVICE LIFE . 31 4.5 * Equivalent safetyAlternat
34、ive RISK CONTROL measures or test methods for ME EQUIPMENT or ME SYSTEMS 31 4.6 * ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT 31 4.7 * SINGLE FAULT CONDITION for ME EQUIPMENT . 31 4.8 * Components of ME EQUIPMENT 32 4.9 * Use of COMPONENTS WITH HIGH-INTEGRITY CHARACTERISTICS in ME EQUIP
35、MENT 33 4.10 * Power supply . 34 4.11 Power input 35 5 * General requirements for testing ME EQUIPMENT 36 5.1 * TYPE TESTS 36 5.2 * Number of samples 36 5.3 Ambient temperature, humidity, atmospheric pressure . 36 5.4 Other conditions . 36 5.5 Supply voltages, type of current, nature of supply, freq
36、uency . 37 5.6 Repairs and modifications 37 5.7 * Humidity preconditioning treatment 38 5.8 Sequence of tests 38 5.9 * Determination of APPLIED PARTS and ACCESSIBLE PARTS 38 6 * Classification of ME EQUIPMENT and ME SYSTEMS 42 6.1 General 42 6.2 * Protection against electric shock . 42 6.3 * Protect
37、ion against harmful ingress of water or particulate matter . 42 6.4 Method(s) of sterilization 42 6.5 Suitability for use in an OXYGEN RICH ENVIRONMENT . 42 6.6 * Mode of operation 43 7 ME EQUIPMENT identification, marking and documents 43 7.1 General 43 7.2 Marking on the outside of ME EQUIPMENT or
38、 ME EQUIPMENT parts . 44 7.3 Marking on the inside of ME EQUIPMENT or ME EQUIPMENT parts 49 7.4 Marking of controls and instruments . 50 7.5 Safety signs . 52 7.6 Symbols . 53 7.7 Colors of the insulation of conductors 53 7.8 * Indicator lights and controls . 54 7.9 ACCOMPANYING DOCUMENTS 54 8 * Pro
39、tection against electrical HAZARDS from ME EQUIPMENT 61 8.1 Fundamental rule of protection against electric shock 61 8.2 Requirements related to power sources . 62 8.3 Classification of APPLIED PARTS . 62 8.4 Limitation of voltage, current or energy 63 8.5 Separation of parts 66 8.6 * Protective ear
40、thing, functional earthing and potential equalization of ME EQUIPMENT 74 8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS 77 8.8 Insulation . 94 8.9 * CREEPAGE DISTANCES and AIR CLEARANCES . 100 8.10 Components and wiring 116 8.11 MAINS PARTS, components and layout . 118 9 * Protection against ME
41、CHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 124 9.1 MECHANICAL HAZARDS of ME EQUIPMENT . 124 9.2 * MECHANICAL HAZARDS associated with moving parts . 125 9.3 * MECHANICAL HAZARD associated with surfaces, corners and edges . 131 9.4 * Instability HAZARDS . 131 9.5 * Expelled parts HAZARD . 136 9
42、.6 Acoustic energy (including infra- and ultrasound) and vibration 136 9.7 * Pressure vessels and parts subject to pneumatic and hydraulic pressure 138 9.8 * MECHANICAL HAZARDS associated with support systems 140 10 * Protection against unwanted and excessive radiation HAZARDS . 147 10.1 X-Radiation
43、 147 10.2 Alpha, beta, gamma, neutron and other particle radiation . 148 10.3 Microwave radiation . 148 10.4 * Lasers and light emitting diodes (LEDs) . 149 10.5 Other visible electromagnetic radiation 149 10.6 Infrared radiation . 149 10.7 Ultraviolet radiation 149 11 * Protection against excessive
44、 temperatures and other HAZARDS . 149 11.1 * Excessive temperatures in ME EQUIPMENT 149 11.2 * Fire prevention 154 11.3 * Constructional requirements for fire ENCLOSURES of ME EQUIPMENT . 159 11.4 * ME EQUIPMENT and ME SYSTEMS intended for use with flammable anesthetics . 161 11.5 * ME EQUIPMENT and
45、 ME SYSTEMS intended for use in conjunction with flammable agents 161 11.6 Overflow, spillage, leakage, ingress of water or particulate matter, cleaning, disinfection, sterilization and compatibility with substances used with the ME EQUIPMENT 161 11.7 Biocompatibility of ME EQUIPMENT and ME SYSTEMS
46、164 11.8 * Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT . 164 12 * Accuracy of controls and instruments and protection against hazardous outputs . 164 12.1 Accuracy of controls and instruments . 164 12.2 USABILITY of ME EQUIPMENT . 164 12.3 ALARM SYSTEMS 164 12.4 Protection agains
47、t hazardous output 164 13 * HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 166 13.1 Specific HAZARDOUS SITUATIONS 166 13.2 SINGLE FAULT CONDITIONS 167 14 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 173 14.1 * General . 173 14.2 * Documentation 173 14.3 * RISK MANAGEMENT plan . 1
48、73 14.4 * PEMS DEVELOPMENT LIFE-CYCLE . 173 14.5 * Problem resolution . 174 14.6 RISK MANAGEMENT PROCESS 174 14.7 * Requirement specification 175 14.8 * Architecture . 175 14.9 * Design and implementation 175 14.10 * VERIFICATION . 176 14.11 * PEMS VALIDATION . 176 14.12 * Modification 176 14.13 * C
49、onnection of PEMS by * PEMS intended to be incorporated into an IT-NETWORK/DATA COUPLING to other equipment 177 15 Construction of ME EQUIPMENT . 178 15.1 * Arrangements of controls and indicators of ME EQUIPMENT 178 15.2 * Serviceability . 178 15.3 Mechanical strength . 178 15.4 ME EQUIPMENT components and general assembly 182 15.5 * MAINS SUPPLY TRANSFORMERS of ME EQUIPMENT and transformers providing separation in accordance with 8.5 188 16 * ME SYSTEMS 192 16.1 * General requirements for the ME SYSTEMS 192 16.2 * ACCOMPANYING DOCUMENTS of an ME SYSTEM 192 16.3 * Power supply . 193
