This procedure is to define the requirements for steam sterilization validation using the overkill method as defined in Annex D of ISO 17665-1:2006 (R2013).
This procedure is intended to provide guidance to the person coordinating steam sterilization validation by a contract sterilizer as well as for performing in-house steam sterilization in accordance with ISO 17665-1:2006 (R2013). Suppliers performing the validation on behalf of your company may rely on their own procedure(s) instead of this procedure, but the person coordinating the validation should verify compliance with ISO 17665-1:2006 (R2013). This procedure is limited to the application of the overkill method of validation for steam sterilization.
You can find other procedures for sterilization validation at:
Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download.
To view all available procedures click here
To review a sample Medical Device Academy procedure click below: