I.S. EN 62353:2014
Current
The latest, up-to-date edition.
MEDICAL ELECTRICAL EQUIPMENT - RECURRENT TEST AND TEST AFTER REPAIR OF MEDICAL ELECTRICAL EQUIPMENT
Hardcopy , PDF
English
01-01-2014
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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 61557-2:2007 | 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) |
| 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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