IEC 60601-1 - Medical Electrical Equipment Safety
Clauses 6 to 7: classification, identification, marking and documents – IEC 60601-1 - Medical Electrical Equipment Safety

IEC 60601-1 - Medical Electrical Equipment Safety 6.4: Method(s) of sterilization

What does 6.4 require?

Equipment or parts intended to be sterilised are classified by the sterilisation method the instructions for use indicate, such as ethylene oxide, irradiation, moist heat or another method the manufacturer validates and describes.

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