ISO 13485 & EU MDR / Would medical face mask necessarily need UV radiation sterilization?
Just curious would a medical face mask necessarily need UV radiation sterilization? Currently I am planning to certify under ISO 13485 in order to supply medical face mask to hospital and healthcare center. Thank you!
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No, the medical mask does not require sterilization. It depends on the manufacturer what kind of mask want to put on the market, what are the customer requirements (for example hospitals) and so on.
Applicable standards for the mask you can find on the following link:
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