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EN 62353:2014

Current
Current

The latest, up-to-date edition.

Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
Published date

31-10-2014

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

IEC 62353:2014 applies 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. For equipment not built to IEC 60601-1 these requirements may be used taking into account the safety standards for the design and information in the instructions for use of that equipment. This standard contains tables with allowable values relating to different editions of IEC 60601-1. For the purpose of this standard, the application of measuring methods is independent of the edition according to which the ME equipment or ME system is designed. This standard contains "general requirements", which contain clauses of general concern, and "particular requirements", further clauses handling special types of ME equipment or ME systems and applying in connection with the "General requirements". This standard is not suitable to assess whether ME equipment or ME systems or any other equipment comply with the relevant standards for their design. This standard is not applicable to the assembly of ME systems. For assembling ME systems see Clause 16 of IEC 60601-1:2005 + IEC 60601-1:2005/AMD1:2012. This standard does not define requirements for repair, exchange of components and modification of ME equipment or ME systems. All maintenance, inspection, servicing, and repair done in accordance with the manufacturer's instructions maintain the conformity to the standard used for the design of the equipment. Otherwise conformity to applicable requirements should be assessed and verified, before the tests of this standard are performed. This standard is also applicable to tests after repair. This second edition cancels and replaces the first edition of IEC 62353 published in 2007. This edition constitutes a technical revision including the following main revisions:- clarification in 5.3.4.1 that measurements of leakage currents based on test configurations derived from IEC 60601-1 are an allowable alternative method and the inclusion of informative explanation in Annex A;- revision of the protective earth resistance requirements for ME systems using multiple socket outlets to take account of IEC 60601-1:2005/AMD1:2012 on the safe allowed values of protective earth resistance of plugged-in equipment;- the inclusion of expected minimum insulation resistance values in Table 2; and- a reordering of the sequence of testing in Annex B.

Committee
CLC/TC 62
DocumentType
Standard
PublisherName
European Committee for Standards - Electrical
Status
Current

Standards Relationship
NF EN 62353 : 2015 Identical
IEC 62353:2014 Identical
NBN EN 62353 : 2015 Identical
NEN EN IEC 62353 : 2014 Identical
I.S. EN 62353:2014 Identical
PN EN 62353 : 2015 Identical
DIN EN 62353 : 2015 Identical
VDE 0751-1 : 2015 Identical
BS EN 62353:2014 Identical
UNE-EN 62353:2015 Identical
CEI EN 62353 : 2015 Identical
SN EN 62353 : 2014 Identical

I.S. EN 61557-16:2015 ELECTRICAL SAFETY IN LOW VOLTAGE DISTRIBUTION SYSTEMS UP TO 1000 V A.C. AND 1500 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
BS EN 61557-16:2015 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 Equipment for testing the effectiveness of the protective measures of electrical equipment and/or medical electrical equipment
EN 61557-16:2015 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

IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV Information technology equipment - Safety - Part 1: General requirements
EN 61557-2:2007 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 2: Insulation resistance
IEC 60364-7-710:2002 Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations
EN 62020:1998/A1:2005 ELECTRICAL ACCESSORIES - RESIDUAL CURRENT MONITORS FOR HOUSEHOLD AND SIMILAR USES (RCMS)
EN 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 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN 60950-1:2006/A2:2013 INFORMATION TECHNOLOGY EQUIPMENT - SAFETY - PART 1: GENERAL REQUIREMENTS (IEC 60950-1:2005/A2:2013, MODIFIED)
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
EN 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
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 61557-2:2007 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 2: Insulation resistance
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)
HD 60364-7-710:2012/AC:2013 LOW-VOLTAGE ELECTRICAL INSTALLATIONS - PART 7-710: REQUIREMENTS FOR SPECIAL INSTALLATIONS OR LOCATIONS - MEDICAL LOCATIONS
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
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
EN 61557-16:2015 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

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