IEC TR 62354:2014
(Main)General testing procedures for medical electrical equipment
General testing procedures for medical electrical equipment
IEC TR 62354:2014 applies to medical electrical equipment. The object of this technical report is to provide guidance on general testing procedures according to IEC 60601-1:1988 (including the collateral provisions of IEC 60601-1-1:2000) and IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012. 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.
This technical report is to be read in conjunction with IEC 60601-1:1988, IEC 60601-1-1:2000 and IEC 60601-1:2005.
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IEC TR 62354 ®
Edition 3.0 2014-09
TECHNICAL
REPORT
General testing procedures for medical electrical equipment
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IEC TR 62354 ®
Edition 3.0 2014-09
TECHNICAL
REPORT
General testing procedures for medical electrical equipment
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
XH
ICS 11.040 ISBN 978-2-8322-1856-3
– 2 – IEC TR 62354:2014 © IEC 2014
CONTENTS
FOREWORD . 6
INTRODUCTION . 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 . 13
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 EQUIPMENT . 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 particular 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
Annex A (informative) Sequence of testing. 165
A.1 Sequence of testing (IEC 60601-1:1988) . 165
A.2 Sequence of testing (IEC 60601-1:2005) . 166
Annex B (informative) Information typically required for product safety testing (Guide) . 168
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 approvals . 168
B.6 Test system . 168
B.7 Power . 168
B.8 Grounding . 169
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 Transformers and chokes . 169
Annex C (informative) Testing and measuring equipment . 170
Annex D (informative) Suitable measuring supply circuits . 171
Annex E (informative) Preventive maintenance . 174
E.1 General . 174
E.2 Cleaning and disinfection . 174
E.3 Preventive maintenance checklist . 174
E.4 OPERATOR checks . 174
Annex F (informative) Test probes . 175
Annex G (informative) Index of tests (IEC 60601-1:2005 clauses order) . 177
Annex H (informative) Index of tests for an INTERNALLY POWERED EQUIPMENT – battery
only – (IEC 60601-1:2005 clauses order) . 179
Annex I (informative) Index of tests (IEC 60601-1:2005 alphabetic order) . 181
Annex J (informative) Index of tests for an INTERNALLY POWERED EQUIPMENT – battery
only – (IEC 60601-1:2005 alphabetic order) . 183
Annex K (informative) Production line tests . 185
K.1 Production-line dielectric voltage-withstand test . 185
K.2 Production-line grounding-continuity test . 186
K.3 Production-line EARTH LEAKAGE CURRENT test . 186
K.4 Recommended features for specific test equipment . 186
Annex L (informative) Evaluation of the laboratory power source characteristics . 189
L.1 Purpose . 189
L.2 Application . 189
L.3 Definitions. 190
L.4 Testing . 191
Annex M (informative) Traceability of calibrations and calibration intervals . 194
M.1 Purpose . 194
M.2 Traceability of calibrations . 194
M.3 Calibration intervals for test equipment requiring calibration . 194
Annex N (informative) Guidance for preparation, attachment, extension, use of
thermocouples and acceptance of thermocouple 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
Annex O (informative) Guideline for safe laboratory work . 201
O.1 BASIC SAFETY guidelines for working with test instruments . 201
O.2 Basic guidelines for performing safety tests . 203
O.3 Basic guidelines regarding test personnel and test areas . 205
– 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 .
...
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