IEC 62353 : 2.0
IEC 62353 : 2.0
MEDICAL ELECTRICAL EQUIPMENT - RECURRENT TEST AND TEST AFTER REPAIR OF MEDICAL ELECTRICAL EQUIPMENT
International Electrotechnical Committee
MEDICAL ELECTRICAL EQUIPMENT - RECURRENT TEST AND TEST AFTER REPAIR OF MEDICAL ELECTRICAL EQUIPMENT
International Electrotechnical Committee
FOREWORD
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Tests
6 Results of test and evaluation
Annex A (informative) - General guidance and rationale
Annex B (informative) - Sequence of testing
Annex C (normative) - Requirements for the measurement equipment and for measurement circuits for
PROTECTIVE EARTH RESISTANCE and leakage currents
Annex D (informative) - PATIENT ENVIRONMENT
Annex E (normative) - Allowable values for leakage currents from IEC 60601-1
Annex F (informative) - Testing intervals
Annex G (informative) - Example of test documentation
Annex H (informative) - Notes on testing ME SYSTEMS
Bibliography
Index of defined terms
Pertains to testing of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS, or parts of such equipment or systems, which comply with IEC 60601-1:1988 (second edition) and its amendments and IEC 60601-1: 2005 (third edition) and its amendments, before PUTTING INTO SERVICE, during MAINTENANCE, INSPECTION, SERVICING and after REPAIR or on occasion of RECURRENT TESTS to assess the safety of such ME EQUIPMENT or ME SYSTEMS or parts thereof.
Document Type | Standard |
Status | Current |
Publisher | International Electrotechnical Committee |
Committee | TC 62 |