Hi, I am a manufacturer of medical face mask and currently my face mask is a type IIR medical face mask under BS EN14683.
Just would like your kind advice whether the sterilization clause in ISO13485:2016 can be "non-applicable" ?
If the sterilization is non-applicable to us, then what is the cleanliness and contamination control procedure details required? Only the cleanroom verification and validation will be sufficient?
Please share your kind advice.
Thank you and have a nice day!
Just would like your kind advice whether the sterilization clause in ISO13485:2016 can be "non-applicable" ?
If the sterilization is non-applicable to us, then what is the cleanliness and contamination control procedure details required? Only the cleanroom verification and validation will be sufficient?
Please share your kind advice.
Thank you and have a nice day!
Last edited: