1、ANSI/AAMI/IEC TIR62354:2009 Association for the Advancementof Medical InstrumentationGeneral testing procedures for medical electrical equipmentAn ANSI Technical Report prepared by AAMI ANSI/AAMI/IEC TIR62354:2009 General testing procedures for medical electrical equipment Approved 31 December 2009
2、by Association for the Advancement of Medical Instrumentation Registered 21 February 2010 by American National Standards Institute, Inc. Abstract: This Technical Report specifies the general harmonized recommendations (conditions and procedures) for testing MEDICAL ELECTRICAL EQUIPMENT (as defined i
3、n Sub-clause 2.2.15 of IEC 60601-1, 2nd edition). This Technical Report is primarily intended to be used by test houses and others responsible for assessment of compliance with IEC 60601-1. Keywords: medical electrical equipment, assessment, testing, maintenance, electrical safety Published by Assoc
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19、MI, Attn: Standards Department, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Contents Page Glossary of equivalent standards viii Committee representation . x Background of ANSI/AAMI adoption of IEC/TR 62354:2009 xi FOREWORD . xii INTRODUCTION xiv 1 Scope and object . 1 2 Normative refere
20、nces . 1 3 Terms, definitions, abbreviations and acronyms 2 4 Types of tests 3 5 State of the ME EQUIPMENT 4 6 Number of samples 4 7 Applicable test items to the clauses of IEC 60601-1 4 8 Sequence of tests 4 9 General testing condition 5 10 Power sources for tests 6 11 Measurement and test equipmen
21、t . 8 12 Treatments of unit symbols and measured values 10 13 PROCEDURES for testing, including particular conditions11 Annex A (informative) Sequence of testing153 Annex B (informative) Information typically required for product safety testing (Guide).156 Annex C (informative) Testing and measuring
22、 equipment 158 Annex D (informative) Suitable measuring supply circuits 159 Annex E (informative) Preventive maintenance .163 Annex F (informative) Test probes 164 Annex G (informative) Index of tests (IEC 60601-1:2005 clauses order).167 Annex H (informative) Index of tests for an INTERNALLY POWERED
23、 EQUIPMENT battery only (IEC 60601-1:2005 clauses order)170 Annex I (informative) Index of tests (IEC 60601-1:2005 alphabetic order) 172 Annex J (informative) Index of tests for an INTERNALLY POWERED EQUIPMENT battery only (IEC 60601-1:2005 alphabetic order)175 Annex K (informative) Production line
24、tests .177 Annex L (informative) Evaluation of the laboratory power source characteristics .181 Annex M (informative) Traceability of calibrations and calibration intervals .186 Annex N (informative) Guidance for preparation, attachment, extension, use of thermocouples and acceptance of thermocouple
25、 wire .188 Annex O (informative) Guideline for safe laboratory work .193 Bibliography 200 Index of defined terms .202 Figure 1 Area of the bottom of an ENCLOSURE as specified in 11.3 b) 1) .30 Figure 2 Baffle30 Figure 3 CREEPAGE DISTANCE and AIR CLEARANCE Example 1 .45 Figure 4 CREEPAGE DISTANCE and
26、 AIR CLEARANCE Example 2 .45 Figure 5 CREEPAGE DISTANCE and AIR CLEARANCE Example 3 .45 Figure 6 CREEPAGE DISTANCE and AIR CLEARANCE Example 4 .46 Figure 7 CREEPAGE DISTANCE and AIR CLEARANCE Example 5 .46 Figure 8 CREEPAGE DISTANCE and AIR CLEARANCE Example 6 .46 Figure 9 CREEPAGE DISTANCE and AIR
27、CLEARANCE Example 7 .47 Figure 10 CREEPAGE DISTANCE and AIR CLEARANCE Example 8 .47 Figure 11 CREEPAGE DISTANCE and AIR CLEARANCE Example 9 .48 Figure 12 Human body test mass66 Figure 13 Application of test voltage to bridged PATIENT CONNECTIONS for DEFIBRILLATION-PROOF APPLIED PARTS .93 Figure 14 A
28、pplication of test voltage to individual PATIENT CONNECTIONS for DEFIBRILLATION-PROOF APPLIED PARTS94 Figure 15 Application of test voltage to test the delivered defibrillation energy .97 Figure 16 Example of a measuring device and its frequency characteristics .99 Figure 17 Measuring circuit for th
29、e EARTH LEAKAGE CURRENT of CLASS I equipment, with or without APPLIED PARTS101 Figure 18 Measuring circuit for the TOUCH CURRENT .104 Figure 19 Measuring circuit for the PATIENT LEAKAGE CURRENT from the PATIENT CONNECTION to earth. .106 Figure 20 Measuring circuit for the total PATIENT LEAKAGE CURRE
30、NT 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 .107 Figure 21 Measuring circuit for the PATIENT LEAKAGE CURRENT via the PATIENT CONNECTION(S) of an F-TYPE APPLIED PART to earth caused by
31、an external voltage on the PATIENT CONNECTION(S) 109 Figure 22 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.110 Figure 23 Measuring circuit for the PATIENT LEAKAGE CURRE
32、NT from PATIENT CONNECTION(S) to earth caused by an external voltage on a SIGNAL INPUT/OUTPUT PART112 Figure 24 Measuring circuit for the PATIENT AUXILIARY CURRENT 114 Figure 25 Ratio between HYDRAULIC TEST PRESSURE AND MAXIMUM PERMISSIBLE WORKING PRESSURE 118 Figure 26 Spark ignition test apparatus
33、 .125 Figure 27 Maximum allowable current I as a function of the maximum allowable voltage U measured in a purely resistive circuit in an OXYGEN RICH ENVIRONMENT.127 Figure 28 Maximum allowable voltage U as a function of the capacitance C measured in a capacitive circuit used in an OXYGEN RICH ENVIR
34、ONMENT .127 Figure 29 Maximum allowable current I as a function of the inductance L measured in an inductive circuit in an OXYGEN RICH ENVIRONMENT .128 Figure D.1 Measuring supply circuit with one side of the SUPPLY MAINS at approximately earth potential .159 Figure D.2 Measuring supply circuit with
35、 SUPPLY MAINS approximately symmetrical to earth potential .159 Figure D.3 Measuring supply circuit for polyphase ME EQUIPMENT specified for connection to a polyphase SUPPLY MAINS 160 Figure D.4 Measuring supply circuit for single-phase ME EQUIPMENT specified for connection to a polyphase SUPPLY MAI
36、NS 160 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 161 Figure F.1 Standard test finger .164 Figure F.2 Test hook 165 Figure F.3 Test pin .165 Figure F.4 Ball-pressure test apparatus.1
37、66 Figure N.1 Thermocouple preparation .188 Figure N.2 Securing of thermocouples.190 Figure N.3 Example of confinement of a thermocouple 190 Figure N.4 Example where thermocouple connectors need not be used .191 Table 1 Units outside the SI units system that may be used.11 Table 2 Tests to be perfor
38、med by inspection .12 Table 3 NOMINAL cross-sectional area of conductors of a POWER SUPPLY CORD23 Table 4 Acceptable perforation of the bottom of an ENCLOSURE 31 Table 5 Measurements and tests performed on non-energized equipment34 Table 6 Testing of cord anchorages 49 Table 7 Acceptable gapsa.55 Ta
39、ble 8 Drop height 80 Table 9 Test torques for rotating controls 86 Table 10 Measurements and tests for equipment that is operating .87 Table 11 Allowable maximum temperatures for skin contact with ME EQUIPMENT APPLIED PARTS135 Table 12 Allowable maximum temperatures for ME EQUIPMENT parts that are l
40、ikely to be touched.135 Table 13 Allowable maximum temperatures of parts 136 Table 14 Temperature limits of motor windings136 Table 15 Maximum motor winding steady-state temperature 137 Table 16 Maximum allowable temperatures of transformer windings under overload and short-circuit conditions at 25
41、C ( 5 C) ambient temperature137 Table 17 Test current for transformers 149 Table C.1 IEC 60601-1:1988 + Amendment 1:1991 and Amendment 2:1995 158 Table D.1 Legends of symbols for Figures D.1 to D.5 162 Table L.1 Method for testing a single phase laboratory power source.183 Glossary of equivalent sta
42、ndards International Standards adopted in the United States may include normative references to other International Standards. For each International Standard that has been adopted by AAMI (and ANSI), the table below gives the corresponding U.S. designation and level of equivalency to the Internatio
43、nal Standard. NOTE: Documents are sorted by international designation. Other normatively referenced International Standards may be under consideration for U.S. adoption by AAMI; therefore, this list should not be considered exhaustive. International designation U.S. designation Equivalency IEC 60601
44、-1:2005 Technical Corrigendum 1 and 2 ANSI/AAMI ES60601-1:2005 ANSI/AAMI ES60601-1:2005/C1:2009 (amdt) Major technical variations C1 Identical to Corrigendum 1 any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and no
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