S
Hi all,
Need your help for a making a single use medical device, class 1. This will be EtO sterilized.
My question is - Do we need to do any cleaning/ ultrasonic bath of the components before assembling the device. Are there any ISO/ASTM standards for this cleaning process and post-cleaning verification.
All my suppliers are ISO9001 certified, but not ISO13485.
We do not want to do the cleaning of complete device before sending out for sterilization and are therefore making it in the clean room.
Looking forward for your comments.
Regards,
CS
Need your help for a making a single use medical device, class 1. This will be EtO sterilized.
My question is - Do we need to do any cleaning/ ultrasonic bath of the components before assembling the device. Are there any ISO/ASTM standards for this cleaning process and post-cleaning verification.
All my suppliers are ISO9001 certified, but not ISO13485.
We do not want to do the cleaning of complete device before sending out for sterilization and are therefore making it in the clean room.
Looking forward for your comments.
Regards,
CS
