1、BSI Standards Publication General testing procedures for medical electrical equipment PD IEC/TR 62354:2014National foreword This Published Document is the UK implementation of IEC/TR 62354:2014. The UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical Equipment
2、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 be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. U
3、sers are responsible for its correct application. The British Standards Institution 2014. Published by BSI Standards Limited 2014 ISBN 978 0 580 87366 9 ICS 11.040.01 Compliance with a British Standard cannot confer immunity from legal obligations. This Published Document was published under the aut
4、hority of the Standards Policy and Strategy Committee on 31 October 2014. Amendments issued since publication Date Text affected PUBLISHED DOCUMENT PD IEC/TR 62354:2014 IEC TR 62354 Edition 3.0 2014-09 TECHNICAL REPORT General testing procedures for medical electrical equipment INTERNATIONAL ELECTRO
5、TECHNICAL COMMISSION XH ICS 11.040 PRICE CODE ISBN 978-2-8322-1856-3 Registered trademark of the International Electrotechnical Commission Warning! Make sure that you obtained this publication from an authorized distributor. PD IEC/TR 62354:2014 2 IEC TR 62354:2014 IEC 2014 CONTENTS FOREWORD . 6 INT
6、RODUCTION . 9 1 Scope and object . 10 2 Normative references 10 3 Terms, definitions, abbreviations and acronyms. 11 3.1 Terms and definitions 11 3.2 Abbreviations and acronyms . 12 4 Types of tests 12 4.1 GENERAL . 12 4.2 Visual inspection . 13 5 State of the ME EQUIPMENT . 13 6 Number of samples 1
7、3 7 Applicable test items to the clauses of IEC 60601-1 13 8 Sequence of tests 13 9 General testing condition . 14 10 Power sources for tests . 15 10.1 General . 15 10.2 Connection to a separate power source 16 10.3 Connection to an external d.c. power source . 16 10.4 Source of power for ME EQUIPME
8、NT 16 10.5 SUPPLY MAINS for testing ME EQUIPMENT . 16 11 Measurement and test equipment 17 11.1 General requirements . 17 11.2 Accuracy . 18 11.3 Safety criteria for selection . 18 11.4 Calibration 18 12 Treatments of unit symbols and measured values 19 13 PROCEDURES for testing, including particula
9、r conditions . 19 13.1 General . 19 13.2 Tests to be performed by inspection . 20 13.3 Measurements and tests performed on non-energized equipment . 41 13.4 Measurements and tests for equipment that is operating . 96 (informative) Sequence of testing. 165 Annex A A.1 Sequence of testing (IEC 60601-1
10、1988) . 165 A.2 Sequence of testing (IEC 60601-1:2005) . 166 (informative) Information typically required for product safety testing (Guide) 168 Annex B B.1 Purpose 168 B.2 Description . 168 B.3 Intended use environment . 168 B.4 Construction . 168 B.5 List of safety-related components and relevant
11、 approvals . 168 B.6 Test system 168 B.7 Power . 168 B.8 Grounding . 169 PD IEC/TR 62354:2014IEC TR 62354:2014 IEC 2014 3 B.9 Modes of operation; configurations . 169 B.10 Failure modes . 169 B.11 RISK ANALYSIS according with ISO 14971 . 169 B.12 Software . 169 B.13 Auxiliary equipment 169 B.14 Tran
12、sformers and chokes 169 (informative) Testing and measuring equipment . 170 Annex C(informative) Suitable measuring supply circuits 171 Annex D(informative) Preventive maintenance 174 Annex E E.1 General . 174 E.2 Cleaning and disinfection 174 E.3 Preventive maintenance checklist . 174 E.4 OPERATOR
13、checks . 174 (informative) Test probes . 175 Annex F(informative) Index of tests (IEC 60601-1:2005 clauses order) . 177 Annex G(informative) Index of tests for an INTERNALLY POWERED EQUIPMENT battery Annex H only (IEC 60601-1:2005 clauses order) 179 (informative) Index of tests (IEC 60601-1:2005 alp
14、habetic order) 181 Annex I(informative) Index of tests for an INTERNALLY POWERED EQUIPMENT battery Annex J only (IEC 60601-1:2005 alphabetic order) 183 (informative) Production line tests 185 Annex K K.1 Production-line dielectric voltage-withstand test 185 K.2 Production-line grounding-continuity t
15、est 186 K.3 Production-line EARTH LEAKAGE CURRENT test . 186 K.4 Recommended features for specific test equipment 186 (informative) Evaluation of the laboratory power source characteristics 189 Annex L L.1 Purpose 189 L.2 Application 189 L.3 Definitions. 190 L.4 Testing . 191 (informative) Traceabil
16、ity of calibrations and calibration intervals 194 Annex M M.1 Purpose 194 M.2 Traceability of calibrations 194 M.3 Calibration intervals for test equipment requiring calibration . 194 (informative) Guidance for preparation, attachment, extension, use of Annex N thermocouples and acceptance of thermo
17、couple wire . 196 N.1 General . 196 N.2 Preparation . 196 N.3 Placement . 196 N.4 Attachment . 197 N.5 Extension 198 N.6 Use . 199 N.7 Acceptance of thermocouples wire 199 (informative) Guideline for safe laboratory work . 201 Annex O O.1 BASIC SAFETY guidelines for working with test instruments . 2
18、01 O.2 Basic guidelines for performing safety tests 203 O.3 Basic guidelines regarding test personnel and test areas 205 PD IEC/TR 62354:2014 4 IEC TR 62354:2014 IEC 2014 O.4 Contents of a documented safe environment for working in a testing laboratory . 206 Bibliography 207 Index of defined terms 2
19、09 Figure 1 Area of the bottom of an ENCLOSURE as specified in 11.3 b) 1) . 37 Figure 2 Baffle . 37 Figure 3 CREEPAGE DISTANCE and AIR CLEARANCE Example 1 . 51 Figure 4 CREEPAGE DISTANCE and AIR CLEARANCE Example 2 . 51 Figure 5 CREEPAGE DISTANCE and AIR CLEARANCE Example 3 . 52 Figure 6 CREEPAGE DI
20、STANCE and AIR CLEARANCE Example 4 . 52 Figure 7 CREEPAGE DISTANCE and AIR CLEARANCE Example 5 . 52 Figure 8 CREEPAGE DISTANCE and AIR CLEARANCE Example 6 . 52 Figure 9 CREEPAGE DISTANCE and AIR CLEARANCE Example 7 . 53 Figure 10 CREEPAGE DISTANCE and AIR CLEARANCE Example 8 . 53 Figure 11 CREEPAGE
21、DISTANCE and AIR CLEARANCE Example 9 . 54 Figure 12 CREEPAGE DISTANCE and AIR CLEARANCE Example 10 . 54 Figure 13 Human body test mass . 73 Figure 14 Application of test voltage to bridged PATIENT CONNECTIONS (common mode) for DEFIBRILLATION-PROOF APPLIED PARTS . 103 Figure 15 Application of test vo
22、ltage to individual PATIENT CONNECTIONS (differential mode) for DEFIBRILLATION-PROOF APPLIED PARTS . 104 Figure 16 Application of test voltage to test the delivered defibrillation energy (energy reduction test) 108 Figure 17 Example of a measuring device and its frequency characteristics . 110 Figur
23、e 18 Measuring circuit for the EARTH LEAKAGE CURRENT of CLASS I equipment, with or without APPLIED PARTS 112 Figure 19 Measuring circuit for the TOUCH CURRENT 115 Figure 20 Measuring circuit for the PATIENT LEAKAGE CURRENT from the PATIENT CONNECTION to earth 117 Figure 21 Measuring circuit for the
24、total PATIENT LEAKAGE CURRENT with all PATIENT CONNECTIONS of all APPLIED PARTS of the same type (TYPE B APPLIED PARTS, TYPE BF APPLIED PARTS or TYPE CF APPLIED PARTS) connected together 118 Figure 22 Measuring circuit for the PATIENT LEAKAGE CURRENT via the PATIENT CONNECTION(S) of an F-TYPE APPLIE
25、D PART to earth caused by an external voltage on the PATIENT CONNECTION(S) 120 Figure 23 Measuring circuit for the PATIENT LEAKAGE CURRENT from PATIENT CONNECTION(S) to earth caused by an external voltage on a metal ACCESSIBLE PART that is not PROTECTIVELY EARTHED . 121 Figure 24 Measuring circuit f
26、or the PATIENT LEAKAGE CURRENT from PATIENT CONNECTION(S) to earth caused by an external voltage on a SIGNAL INPUT/OUTPUT PART . 123 Figure 25 Measuring circuit for the PATIENT AUXILIARY CURRENT 125 Figure 26 Ratio between hydraulic test pressure and maximum permissible working pressure . 129 Figure
27、 27 Spark ignition test apparatus 136 Figure 28 Maximum allowable current I as a function of the maximum allowable voltage U measured in a purely resistive circuit in an OXYGEN RICH ENVIRONMENT 139 PD IEC/TR 62354:2014IEC TR 62354:2014 IEC 2014 5 Figure 29 Maximum allowable voltage U as a function o
28、f the capacitance C measured in a capacitive circuit used in an OXYGEN RICH ENVIRONMENT . 139 Figure 30 Maximum allowable current I as a function of the inductance L measured in an inductive circuit in an OXYGEN RICH ENVIRONMENT 140 Figure D.1 Measuring supply circuit with one side of the SUPPLY MAI
29、NS at approximately earth potential 171 Figure D.2 Measuring supply circuit with SUPPLY MAINS approximately symmetrical to earth potential . 171 Figure D.3 Measuring supply circuit for polyphase ME EQUIPMENT specified for connection to a polyphase SUPPLY MAINS . 171 Figure D.4 Measuring supply circu
30、it for single-phase ME EQUIPMENT specified for connection to a polyphase SUPPLY MAINS . 172 Figure D.5 Measuring supply circuit for ME EQUIPMENT having a separate power supply unit or intended to receive its power from another equipment in an ME SYSTEM . 172 Figure F.1 Standard test finger 175 Figur
31、e F.2 Test hook 176 Figure F.3 Test pin . 176 Figure F.4 Ball-pressure test apparatus . 176 Figure N.1 Thermocouple preparation 196 Figure N.2 Securing of thermocouples . 197 Figure N.3 Example of confinement of a thermocouple . 198 Figure N.4 Example where thermocouple connectors need not be used .
32、 199 Table 1 Units outside the SI units system that may be used . 19 Table 2 Tests to be performed by inspection 20 Table 3 NOMINAL cross-sectional area of conductors of a POWER SUPPLY CORD . 31 Table 4 Acceptable perforation of the bottom of an ENCLOSURE 38 Table 5 Measurements and tests performed
33、on non-energized equipment . 41 Table 6 Testing of cord anchorages . 56 Table 7 Acceptable gapsa62 Table 8 Drop height . 87 Table 9 Test torques for rotating controls . 93 Table 10 Measurements and tests for equipment that is operating . 96 Table 11 Allowable maximum temperatures for skin contact wi
34、th ME EQUIPMENT APPLIED PARTS . 147 Table 12 Allowable maximum temperatures for ME EQUIPMENT parts that are likely to be touched 147 Table 13 Allowable maximum temperatures of parts . 148 Table 14 Temperature limits of motor windings 148 Table 15 Maximum motor winding steady-state temperature 149 Ta
35、ble 16 Maximum allowable temperatures of transformer windings under overload and short-circuit conditions at 25 C ( 5 C) ambient temperature 149 Table 17 Test current for transformers . 162 Table C.1 IEC 60601-1:1988+AMD 1:1991 and AMD 2:1995 170 Table D.1 Legends of symbols for Figure D.1 to Figure
36、 D.5 . 173 Table L.1 Method for testing a single phase laboratory power source. 191 PD IEC/TR 62354:2014 6 IEC TR 62354:2014 IEC 2014 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ GENERAL TESTING PROCEDURES FOR MEDICAL ELECTRICAL EQUIPMENT FOREWORD 1) The International Electrotechnical Commission (IEC
37、) 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 this end and in addition
38、 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 National Committee interested
39、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 (ISO) in accordance with co
40、nditions 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 from all interested IEC N
41、ational 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 held responsible for the
42、 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 divergence between any
43、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 IEC marks of conformity
44、 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 individual experts and members of
45、 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 IEC Publication or any
46、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 IEC Publication may be
47、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 when it has collected data
48、of a different kind from that which is normally published as an International Standard, for example “state of the art“. IEC 62354, which is a technical report, has been prepared by subcommittee 62A: Common aspects of electrical equipment used in medical practice, of IEC technical committee 62: Elect
49、rical equipment in medical practice. This third edition cancels and replaces the second edition published in 2009. This edition constitutes a technical revision intended to align the guidance in this technical report with Amendment 1 to IEC 60601:2005. Several tests have been updated and additional test procedures added. The following tests have been added or significantly revised: 13.2.1
