What is BS EN ISO 11607-2 - Packaging for terminally sterilized medical devices about?
It’s critical that medical devices are sterile up to the point of use. BS EN ISO 11607-2:2020+A1:2023 is an amended international standard that specifies requirements for the development and validation of packaging processes for terminally sterilized medical devices.
Who is BS EN ISO 11607-2 - Packaging for terminally sterilized medical devices for?
- Manufacturers of medical devices, including IVDs
- Manufacturers of packaging materials and packaging systems for sterile devices
- Healthcare facilities with in house or contracted sterilization services
What does BS EN ISO 11607-2 - Packaging for terminally sterilized medical devices cover?
BS EN ISO 11607-2 specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
It applies to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.
NOTE: BS EN ISO 11607-2:2020+A1:2023 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
Why should you use BS EN ISO 11607-2 - Packaging for terminally sterilized medical devices?
- It supports compliance with the General Safety and Performance Requirements (GSPR) in the EU MDR
- It supports increased focus internationally on requirements for sterile barrier systems for sterile medical devices
- It addresses the usability of packaging as well as physical and microbiological performance
- The amendment expands on the application of risk management throughout the phases of design and development, and validation and production of the packaging system
- It promotes state of the art procedures
- It can help users to develop their expertise in terminal sterilization
- It can help users increase confidence in their medical devices and trade more readily
- It can help users improve their efficiency and strengthen their risk management
What’s new about BS EN ISO 11607-2:2020+A1:2023?
This is an amendment to BS EN ISO 11607-2:2019. The major changes in BS EN ISO 11607-2:2020+A1:2023 are around the expanded application of risk management, reflected in:
- Revisions to Clause 3 and Clause 4.2
- A new normative Annex B on risk management
