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I.S. EN 62353:2014

Current
Current

The latest, up-to-date edition.

MEDICAL ELECTRICAL EQUIPMENT - RECURRENT TEST AND TEST AFTER REPAIR OF MEDICAL ELECTRICAL EQUIPMENT
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2014

Publisher

National Standards Authority of Ireland

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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
Annex ZA (normative) - Normative references to international
         publications with their corresponding European
         publications

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.

DevelopmentNote
For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
DocumentType
Standard
Pages
142
PublisherName
National Standards Authority of Ireland
Status
Current

Standards Relationship
EN 62353:2014 Identical

IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV Information technology equipment - Safety - Part 1: General requirements
IEC 60364-7-710:2002 Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
IEC 61557-1:2007 Electrical safety in low voltage distribution systems up to 1 000 V a.c. and 1 500 V d.c. - Equipment for testing, measuring or monitoring of protective measures - Part 1: General requirements
IEC 61557-16:2014 Electrical safety in low voltage distribution systems up to 1 000 V a.c. and 1 500 V d.c - Equipment for testing, measuring or monitoring of protective measures - Part 16: Equipment for testing the effectiveness of the protective measures of electrical equipment and/or medical electrical equipment
EN 61010-031:2015 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 031: Safety requirements for hand-held probe assemblies for electrical measurement and test
EN 61557-1:2007 Electrical safety in low voltage distribution systems up to 1 000 V a.c. and 1 500 V d.c. - Equipment for testing, measuring or monitoring of protective measures - Part 1: General requirements
IEC 62020:1998+AMD1:2003 CSV Electrical accessories - Residual current monitors for household and similar uses (RCMs)
IEC 61010-031:2015 RLV Safety requirements for electrical equipment for measurement, control and laboratory use - Part 031: Safety requirements for hand-held probe assemblies for electrical measurement and test
EN 61140:2016 Protection against electric shock - Common aspects for installation and equipment
IEC 61557-4:2007 Electrical safety in low voltage distribution systems up to 1 000 V a.c. and 1 500 V d.c. - Equipment for testing, measuring or monitoring of protective measures - Part 4: Resistance of earth connection and equipotential bonding
IEC 61010-2-010:2014 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the heating of materials
EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
ISO 14971:2007 Medical devices Application of risk management to medical devices
IEC 61140:2016 Protection against electric shock - Common aspects for installation and equipment
IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements

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