Comitato Elettrotecnico Italiano

Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
 N EN 62353

Annotation

This International Standard 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".

NOTE At this stage, there are no particular 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/AMD1:20121.