Sterile Instruments Packaging

There isn't anything in the ISO 13485:2016 about Sterile packaging changing color. It is rather specific because each manufacturer of sterile packaging has its own method of detection. However, in ISO 13485:2016 in requirement 7.5.7 Particular requirements for validation of a process for sterilization and sterile barrier system is stated that process for sterilization and sterile barrier system must be validated and that records of that validation must be maintained. It means that you need to define which is the criterion for sterilization to be declared successful. Therefore, you need to contact the manufacturer of sterile packaging to see how sterile barrier has to behave when the sterilization process is properly conducted.

For more information on this topic, please see the following links:

• How to manage the medical device sterilization process according to ISO 13485:2016 https://advisera.com/13485academy/blog/2017/06/28/how-to-manage-the-medical-device-sterilization-process-according-to-iso-13485/
• Using ISO 13485 to manage process validation in the medical device manufacturing industry https://advisera.com/13485academy/blog/2017/09/07/using-iso-13485-to-manage-process-validation-in-the-medical-device-manufacturing-industry/