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IEC TR 62354 : 3.0

IEC TR 62354 : 3.0

GENERAL TESTING PROCEDURES FOR MEDICAL ELECTRICAL EQUIPMENT

International Electrotechnical Committee

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Table of Contents

FOREWORD
INTRODUCTION
1 Scope and object
2 Normative references
3 Terms, definitions, abbreviations and acronyms
4 Types of tests
5 State of the ME EQUIPMENT
6 Number of samples
7 Applicable test items to the clauses of IEC 60601-1
8 Sequence of tests
9 General testing condition
10 Power sources for tests
11 Measurement and test equipment
12 Treatments of unit symbols and measured values
13 PROCEDURES for testing, including particular
   conditions
Annex A (informative) - Sequence of testing
Annex B (informative) - Information typically required
        for product safety testing (Guide)
Annex C (informative) - Testing and measuring equipment
Annex D (informative) - Suitable measuring supply circuits
Annex E (informative) - Preventive maintenance
Annex F (informative) - Test probes
Annex G (informative) - Index of tests (IEC 60601-1:2005
        clauses order)
Annex H (informative) - Index of tests for an
        INTERNALLY POWERED EQUIPMENT - battery only -
        (IEC 60601-1:2005 clauses order)
Annex I (informative) - Index of tests (IEC 60601-1:2005
        alphabetic order)
Annex J (informative) - Index of tests for an INTERNALLY
        POWERED EQUIPMENT - battery only -
        (IEC 60601-1:2005 alphabetic order)
Annex K (informative) - Production line tests
Annex L (informative) - Evaluation of the laboratory
        power source characteristics
Annex M (informative) - Traceability of calibrations
        and calibration intervals
Annex N (informative) - Guidance for preparation,
        attachment, extension, use of thermocouples and
        acceptance of thermocouple wire
Annex O (informative) - Guideline for safe laboratory work
Bibliography
Index of defined terms

Abstract

Pertains to MEDICAL ELECTRICAL EQUIPMENT (as defined in Subclauses 3.63 of IEC 60601-1:2005 and 2.2.15 of IEC 60601-1:1988).

General Product Information

Document Type Standard
Status Current
Publisher International Electrotechnical Committee
Committee TC 62

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