1、BSI Standards Publication Medical electrical equipment Part 4-3: Guidance and interpretation Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements PD IEC/TR 60601-4-3:2015National foreword This Published Document is the UK implementation
2、of IEC/TR 60601-4-3:2015. The UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/1, Common aspects of Electrical Equipment used in Medical Practice. A list of organizations represented on this committee can
3、be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2015. Published by BSI Standards Limited 2015 ISBN 978 0 580 85664 8 ICS 11.040 Compl
4、iance with a British Standard cannot confer immunity from legal obligations. This Published Document was published under the authority of the Standards Policy and Strategy Committee on 30 April 2015. Amendments/corrigenda issued since publication Date Text affected PUBLISHED DOCUMENT PD IEC/TR 60601
5、-4-3:2015IEC TR 60601-4-3 Edition 1.0 2015-04 TECHNICAL REPORT Medical electrical equipment Part 4-3: Guidance and interpretation Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements INTERNATIONAL ELECTROTECHNICAL COMMISSION ICS 11.040 I
6、SBN 978-2-8322-2613-1 Registered trademark of the International Electrotechnical Commission Warning! Make sure that you obtained this publication from an authorized distributor. 2 IEC TR 60601-4-3:2015 IEC 2015 CONTENTS FOREWORD . 5 INTRODUCTION . 7 1 Scope and object . 8 1.1 Scope . 8 1.2 Object .
7、8 2 Normative references 8 3 Recommendations . 9 3.1 Template used for recommendations prepared by SC 62A/WG 14 9 3.2 Recommendation sheets . 10 3.2.101 Total PATIENT LEAKAGE CURRENT of a ME SYSTEM . 10 3.2.102 Pollution degree for MOPP 10 3.2.103 Transients on d.c. mains 11 3.2.104 Altitude factor
8、for DEFIBRILLATION-PROOF APPLIED PARTS 12 3.2.105 Defibrillation energy protection for MOOP / MOPP . 13 3.2.106 Overvoltage categories III and IV . 13 3.2.107 Pollution degree related to different micro/macro environments . 13 3.2.108 Warnings versus ALARM SIGNALS 14 3.2.109 Single Y1 capacitor for
9、MOPP . 14 3.2.110 WORKING VOLTAGE 14 140 V peak . 15 3.2.111 CREEPAGE DISTANCE and AIR CLEARANCE for dental equipment 15 3.2.112 Short circuiting of one constituent part of DOUBLE INSULATION . 16 3.2.113 Instability in transport position . 16 3.2.114 When to conduct leakage current tests after humid
10、ity preconditioning treatment . 17 3.2.115 DEFIBRILLATION-PROOF TYPE B APPLIED PARTS 17 3.2.116 Instability excluding transport position . 18 3.2.117 DIELECTRIC STRENGTH of two serial MOPP barrier parts 18 3.2.118 Overheating transformer 19 3.2.119 Test equipment for recurrent tests according to IEC
11、 62353 testing used within IEC 60601-1 type approval testing . 20 3.2.120 Tolerances of apparatus 22 3.2.121 FUNCTIONAL EARTH CONDUCTOR and ESSENTIAL PERFORMANCE 23 3.2.122 A.c. motors 24 3.2.123 Operational insulation 25 3.2.124 WORKING VOLTAGE measurement 25 3.2.125 Defibrillation test 26 3.2.126
12、Oil containers for moving parts 27 3.2.127 PERMANENTLY INSTALLED ME EQUIPMENT in the HOME HEALTHCARE ENVIRONMENT . 27 3.2.128 Polystyrene plate for LEAKAGE CURRENT tests . 30 3.2.129 Push buttons . 31 3.2.130 Temperature limit at the ENCLOSURE in SINGLE FAULT CONDITION 31 3.2.131 Optic coupler requi
13、rements 33 3.2.132 Eye-verification of tester before legibility test . 35 3.2.133 End stops to prevent overtravel . 36 3.2.134 MOPP barrier with low WORKING VOLTAGE r.m.s. and high WORKING VOLTAGE peak 37 PD IEC/TR 60601-4-3:2015IEC TR 60601-4-3:2015 IEC 2015 3 3.2.135 Labeling: spare parts vs. deta
14、chable parts vs. ACCESSORIES 38 3.2.136 Protective earth impedance of ME SYSTEM 200 m . 41 3.2.137 Ball pressure test . 42 3.2.138 Magnesium alloy ENCLOSURE 43 3.2.139 Instability with initial movement . 44 3.2.140 Ball pressure test . 45 3.2.141 DIELECTRIC STRENGTH test values . 47 3.2.142 SECONDAR
15、Y CIRCUITS 48 3.2.143 LEAKAGE CURRENTS in SINGLE FAULT CONDITION and during component faults . 48 3.2.144 Impedance of a PROTECTIVE EARTH CONDUCTOR within a DETACHABLE POWER SUPPLY CORD . 49 3.2.145 Time delay of the 100 VA limit . 50 3.2.146 Test voltage multiplied by factor 1,6 51 3.2.147 Overflow
16、, spillage, . 51 3.2.148 DIELECTRIC STRENGTH test of transformers without accessible frame 52 3.2.149 Expected voltage on SIP/SOPs 52 3.2.150 Flammability rating for transformer bobbin . 53 3.2.151 COMPONENT WITH HIGH-INTEGRITY CHARACTERISTICS . 54 3.2.152 Peak and r.m.s. WORKING VOLTAGES . 55 3.2.1
17、53 Critical components . 56 3.2.154 LEAKAGE CURRENT test for ME EQUIPMENT with multiple APPLIED PARTS . 56 3.2.155 DIELECTRIC STRENGTH test value for extruded and spirally wrapped multi- layer wires . 57 3.2.156 DIELECTRIC STRENGTH test after thermal cycling test . 57 3.2.157 Required MOOP values hi
18、gher than MOPP values . 58 3.2.158 Optocouplers . 58 3.2.159 Impact test . 59 3.2.160 Spillage test in NORMAL CONDITION and in SINGLE FAULT CONDITION 60 3.2.161 TYPE B APPLIED PART connected to ACCESSIBLE PARTS . 61 3.2.162 Current/power labeling . 62 3.2.163 Separate power supply part of ME EQUIPME
19、NT or ME SYSTEM . 62 3.2.164 Specification of the allowed power supply 63 3.2.165 Mains transients for opposite polarity on the secondary side or battery pole to pole barrier 64 3.2.166 Keep dry and umbrella symbol . 65 3.2.167 MOBILE and STATIONARY ME EQUIPMENT with wheels 66 3.2.168 Varistors inst
20、alled in the MAINS PART 67 3.2.169 Using Y2 capacitors for MOPP 67 3.2.170 Overtravel end stops specification of the speed 68 3.2.171 CREEPAGE DISTANCE and AIR CLEARANCE between input and output of fuse contacts . 69 3.2.172 Examples of SINGLE FAULT CONDITION . 69 3.2.173 Examples of ME SYSTEMS . 70
21、 3.2.174 Cross sectional area of POWER SUPPLY CORD for rated input current 63 A 70 3.2.175 Biocompatibility for quasi APPLIED PARTS 71 3.2.176 Floating reference earth. 71 3.2.177 SINGLE FAULT CONDITION in OXYGEN RICH ENVIRONMENT 72 3.2.178 Laser requirements 74 PD IEC/TR 60601-4-3:2015 4 IEC TR 606
22、01-4-3:2015 IEC 2015 3.2.179 Flammability rating of insulated wires 74 3.2.180 Infrared lamps . 75 3.2.181 Identification of internal fuses 76 3.2.182 Chargers for ME EQUIPMENT used at home 77 3.2.183 CLASS II ME EQUIPMENT with FUNCTIONAL EARTH CONDUCTOR 78 3.2.184 Symbol D2-2 on MSO 78 3.2.185 PATI
23、ENT leads connectors 79 3.2.186 Rationale for IP2X . 80 3.2.187 Battery limited power 80 3.2.188 TYPE B APPLIED PART separated from ACCESSIBLE PARTS 81 3.2.189 Protective earth test 25A . 81 3.2.190 Reference to IEC 62304:2006 82 3.2.191 The SIP/SOP pin to earth TOUCH CURRENT 82 3.2.192 Overbalancin
24、g . 84 3.2.193 MAINS VOLTAGE on APPLIED PART . 85 Annex A (informative) Overview of the recommendations developed by IEC/SC 62A/WG 14 . 86 Bibliography 91 Table A.1 Cross-reference of recommendations by subclause of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 (1 of 5) . 86 PD IEC/TR 60601-4-3:20
25、15IEC TR 60601-4-3:2015 IEC 2015 5 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 4-3: Guidance and interpretation Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements FOREWORD 1) The International Electrot
26、echnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To
27、this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC Nation
28、al Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non- governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (IS
29、O) 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 international consensus of opinion on the relevant subjects since each technical committee has representation f
30、rom 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 reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be
31、held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any
32、 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 conformity. Independent certification bodies provide conformity assessment services and, in some areas, access to
33、 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 publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents including individua
34、l experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this
35、 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 correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this
36、 IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. The main task of IEC technical committees is to prepare International Standards. However, a technical committee may propose the publication of a technical report whe
37、n it has collected data of a different kind from that which is normally published as an International Standard, for example “state of the art“. IEC TR 60601-4-3, which is a technical report, has been prepared by subcommittee 62A: Common aspects of electrical equipment used in medical practice, of IE
38、C technical committee 62: Electrical equipment in medical practice. PD IEC/TR 60601-4-3:2015 6 IEC TR 60601-4-3:2015 IEC 2015 The text of this technical report is based on the following documents: Enquiry draft Report on voting 62A/951/DTR 62A/973A/RVC Full information on the voting for the approval
39、 of this technical report can be found in the report on voting indicated in the above table. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. Terms used throughout this technical report that have been defined in Clause 3 of IEC 60601-1:2005 and IEC 60601-1:2005/AM
40、D 1:2012 are printed in SMALL CAPITALS. The committee has decided that the contents of this publication will remain unchanged until the stability date indicated on the IEC website under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be rec
41、onfirmed, withdrawn, replaced by a revised edition, or amended. A bilingual version of this technical report may be issued at a later date. PD IEC/TR 60601-4-3:2015IEC TR 60601-4-3:2015 IEC 2015 7 INTRODUCTION At the Sydney meeting in August 1994, IEC subcommittee (SC) 62A established a procedure un
42、der which working group (WG) 14 would develop recommendations regarding problems of interpretation or application of IEC 60601-1. WG 14 is made up of experts with particular expertise in testing according to the requirements of IEC 60601-1. Many of the experts on WG 14 are employed by test laborator
43、ies with a long history of applying IEC 60601-1 to MEDICAL ELECTRICAL EQUIPMENT. While the National Committee members of SC 62A nominate these experts, their recommendations were not to be formally adopted through any official voting procedure. To reinforce this process, the Subcommittee specificall
44、y directed that the following note appear on every page of the resulting informational circular: IMPORTANT NOTE: Per the 62A decision at Sydney (see RM3755/SC62A, August 1994), the 62A Secretary is circulating this recommendation, prepared by 62A/WG 14, regarding problems of interpretation or applic
45、ation of IEC 60601-1 to all P-Member NCs. This recommendation/interpretation is the result of considerations by a group of nominated experts and has not been formally adopted through any National Committee voting procedure. Distribution is only for information. At the November 2000 meeting of SC 62A
46、 in Tokyo, the subcommittee discussed ways and means for achieving a wider distribution of the WG 14 recommendations. At the conclusion of this discussion, the subcommittee instructed the Secretariat to develop a technical report (TR) based on the published recommendations of WG 14. This technical r
47、eport is intended to convey the results of WG 14s work to interested parties such as MANUFACTURERS and test laboratories while retaining the informative nature of the material. This first edition of IEC TR 60601-4-3 contains 93 recommendations, numbered 101 to 193. All these recommendations are base
48、d upon IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012. The numbering starts with 101 instead of just 1 to ensure that these WG 14 recommendations (101 to 193) will not accidentally be confused with previous issued WG 14 recommendations 1 to 63, which are based on the second edition of IEC 60601-1 a
49、nd published in IEC TR 62296. This technical report may be amended from time to time as WG 14 prepares additional recommendations. PD IEC/TR 60601-4-3:2015 8 IEC TR 60601-4-3:2015 IEC 2015 MEDICAL ELECTRICAL EQUIPMENT Part 4-3: Guidance and interpretation Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements 1 Scope and object 1.1 Scope This technical report contains a series of recommendations developed by an expert working group of IEC s
