ANSI AAMI 60601-1-2-2014 MEDICAL ELECTRICAL EQUIPMENT C Part 1-2 General requirements for basic safety and essential performance C Collateral Standard Electromagnetic disturbances .pdf

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

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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

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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