Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment (IEC 62353:2007, IDT)
This Malaysian 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 MS IEC 60601-1, 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 MS 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 Malaysian Standard contains tables with allowable values relating to different editions of MS 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 Malaysian Standard contains:
- general requirements", which contain clauses of general conce
Published
• (none) / (none) / (none)
PDF
22/01/2021
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NSC 18 - Medical Devices and Facilities for Healthcare
