Packaging terminally sterilized medical devices – ISO standards

19 October 2017

The process of designing and developing a packaging system for terminally sterilized medical devices is a complicated and critical endeavour. The device components and the packaging system should be combined to create a product that performs efficiently, safely, and effectively in the hands of the user.
Recently two global standards were published for packaging for terminally sterilized medical devices. NEN-EN-ISO 11607-1:2017 specifies the basic attributes required of materials and pre-formed systems. NEN-EN-ISO 11607-2:2017 describes the validation requirements for forming, sealing and assembly processes (World Packaging Standardisation Newsletter, October 2017).
Click here for more information about NEN-EN-ISO 11607-1:2017.
Click here for more information about NEN-EN-ISO 11607-2:2017.
Click here for more information about the World Packaging Standardisation Newsletter (WPSN), including how to obtain your complimentary subscription.
Click here for more information about the NVC E-Course Pharmaceutical Packaging.

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