13/30250915 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN 62353 - MEDICAL ELECTRICAL EQUIPMENT - RECURRENT TEST AND TEST AFTER REPAIR OF MEDICAL ELECTRICAL EQUIPMENT
Hardcopy , PDF
English
31-12-2014
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 (informative) - 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
BS EN 62353
| Committee |
CH/62/1
|
| DocumentType |
Draft
|
| Pages |
62
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| 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 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 |
| 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 |
| 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 |
| IEC 60601-1-1:2000 | Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
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