1、ANSI/AAMI/IEC 60601-1-2:2014 MEDICAL ELECTRICAL EQUIPMENT Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic disturbances Requirements and testsAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is
2、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 to such advancement are (1)
3、 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 instrumentation, provided that they
4、 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 performance criteria that should be
5、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 emphasize the information th
6、at 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 of performance characteristi
7、cs 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 establishment of minimum safety and
8、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 address device perfor
9、mance 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 or user of the de
10、vice 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 recommended practice
11、s, 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 guidelines may be useful t
12、o 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 practices are vo
13、luntary (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 reflects the coll
14、ective 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 clinical needs and, u
15、ltimately, 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 reference in responsi
16、ble 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 carefully review
17、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 devices and equipmen
18、t, 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 criteria to existing e
19、quipment. 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, cost-benefit consid
20、erations. 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 underlying its provis
21、ion. 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 Requests for interpret
22、ations 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 Standards Board. The int
23、erpretation 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 responsibility for
24、 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 ANSI/AAMI/IEC 60601
25、-1-2:2014 (Revision of ANSI/AAMI/IEC 60601-1-2:2007/(R)2012) MEDICAL ELECTRICAL EQUIPMENT Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic disturbances Requirements and tests Approved 10 March 2014 by Association for the Advancement of Me
26、dical Instrumentation Approved 9 May 2014 by American National Standards Institute, Inc. Abstract: Specifies general requirements and tests for basic safety and essential performance with regard to electromagnetic disturbances of medical electrical (ME) equipment and ME systems. They are in addition
27、 to the requirements of the general standard and serve as the basis for particular standards. Applicability of this collateral standard includes ME equipment and ME systems that have been found to have no essential performance. Keywords: electromagnetic compatibility, EMC, electromagnetic disturbanc
28、e 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 they have approved the standard or no
29、t, 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 be revised or withdrawn at any time.
30、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 the AAMI website at www.aami.org. All
31、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. Occasionally, voluntary technical documents are a
32、dopted 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, Suite 301 Arlington, VA 22203-1633 www.aa
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36、x Drive, Suite 301, Arlington, VA 22203-1633. Phone: 703-525-4890; Fax: 703-525-1067. Printed in the United States of America ISBN 157020524-8 CONTENTS Glossary of equivalent standards . vii Committee representation . viii Background of ANSI/AAMI adoption of IEC 60601-1-2:2014 ix FOREWORD . x INTROD
37、UCTION xiii 1 Scope, object and related standards 1 1.1 * Scope 1 1.2 Object. 1 1.3 Related standards 1 1.3.1 IEC 60601-1 1 1.3.2 Particular standards 1 2 Normative references . 2 3 Terms and definitions . 4 4 General requirements . 7 4.1 RISK MANAGEMENT PROCESS for ME EQUIPMENT and ME SYSTEMS . 7 4
38、.2 * Non-ME EQUIPMENT used in an ME SYSTEM . 7 4.3 General test conditions . 8 4.3.1 * Configurations 8 4.3.2 Artificial hand 8 4.3.3 * Power input voltages and frequencies . 9 5 ME EQUIPMENT and ME SYSTEMS identification, marking and documents . 11 5.1 Additional requirements for marking on the out
39、side of ME EQUIPMENT and ME SYSTEMS that are specified for use only in a shielded location SPECIAL ENVIRONMENT 11 5.2 ACCOMPANYING DOCUMENTS . 12 5.2.1 Instructions for use 12 5.2.2 Technical description 13 6 Documentation of the tests . 14 6.1 General 14 6.2 Test plan 15 6.3 Test report 15 7 ELECTR
40、OMAGNETIC EMISSIONS requirements for ME EQUIPMENT and ME SYSTEMS . 15 7.1 Protection of radio services and other equipment . 15 7.1.1 * General . 15 7.1.2 Operating modes . 15 7.1.3 Multimedia equipment . 15 7.1.4 * Subsystems 15 7.1.5 ME EQUIPMENT and ME SYSTEMS specified for use only in a shielded
41、 location SPECIAL ENVIRONMENT . 15 7.1.6 ME EQUIPMENT and ME SYSTEMS that include radio equipment 16 7.1.7 * ME EQUIPMENT whose main functions are performed by motors and switching or regulating devices . 16 7.1.8 ME EQUIPMENT and ME SYSTEMS containing X-ray generators 16 7.1.9 PATIENT physiological
42、 simulation 16 7.1.10 Artificial hand 17 7.1.11 PATIENT-coupled cables . 17 7.1.12 PERMANENTLY INSTALLED LARGE ME EQUIPMENT and LARGE ME SYSTEMS . 17 7.2 Protection of the PUBLIC MAINS NETWORK 17 7.2.1 * Harmonic distortion . 17 7.2.2 * Voltage fluctuations and flicker . 18 7.3 EMISSIONS requirement
43、s summary 18 8 Electromagnetic IMMUNITY requirements for ME EQUIPMENT and ME SYSTEMS 18 8.1 * General 18 8.2 PATIENT physiological simulation . 22 8.3 Termination of PATIENT-COUPLED parts 22 8.4 HAND-HELD ME EQUIPMENT and parts intended to be HAND-HELD . 22 8.5 * Subsystems . 23 8.6 PERMANENTLY INST
44、ALLED LARGE ME EQUIPMENT and LARGE ME SYSTEMS . 23 8.7 * Operating modes 24 8.8 * Non-ME EQUIPMENT . 24 8.9 * IMMUNITY TEST LEVELS . 24 8.10 * IMMUNITY to proximity fields from RF wireless communications equipment 32 9 * Test report . 34 Annex A (informative) General guidance and rationale . 37 A.1
45、Safety and performance 37 A.2 Testing of normally non-observable functions . 37 A.3 Rationale for particular clauses and subclauses . 37 Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS . 52 B.1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or th
46、eir parts 52 B.2 ACCOMPANYING DOCUMENTS, instructions for use . 52 B.3 ACCOMPANYING DOCUMENTS, technical description . 52 Annex C (informative) Guidance in classification according to CISPR 11 54 C.1 General 54 C.2 Separation into groups . 54 C.3 Division into classes . 55 Annex D (informative) Guid
47、ance in the application of IEC 60601-1-2 to particular standards 56 D.1 General 56 D.2 Recommended modifications 56 D.2.1 Testing requirements . 56 D.2.2 ACCOMPANYING DOCUMENTS 56 D.3 Cautions . 56 Annex E (informative) Determination of IMMUNITY TEST LEVELS for SPECIAL ENVIRONMENTS 58 E.1 General 58
48、 E.2 Summary of method for E.1 a) 61 E.3 Summary of method for E.1 b), c) and d) 61 E.4 Determination of EM DISTURBANCE level reduction . 61 E.5 Assessment of EM DISTURBANCE sources . 61 E.6 Reasonably foreseeable maximum EM DISTURBANCE levels 62 E.7 Determination of IMMUNITY TEST LEVELS . 62 E.8 RF
49、 radiators in SPECIAL ENVIRONMENTS 63 E.9 Examples of mitigations and special conditions 63 Annex F (informative) RISK MANAGEMENT for BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to ELECTROMAGNETIC DISTURBANCES . 65 F.1 General 65 F.2 General requirements for RISK MANAGEMENT 66 F.3 RISK ANALYSIS . 67 F.4 RISK EVALUATION . 71 F.5 RISK CONTROL . 71 F.5.1 RISK CONTROL option analysis 71 F.5.2 Implementation of RISK CONTROL measure(s) . 71 F.5.3 RESIDUAL RISK EVALUATION . 72 F.5.4 RISK/benefit analysis . 72 F.5.5 RISKS arising from RISK CONTROL measures . 72 F.5.6 Comple
