What is BS EN ISO 11607-1 - Packaging for terminally sterilized medical devices about?
It’s critical that medical devices are sterile up to the point of use. BS EN ISO 11607-1:2020+A1:2023 is an amended international standard that specifies requirements for the design of sterile barrier systems and protective packaging systems for terminally sterilized medical devices.
Who is BS EN ISO 11607-1 - 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 11607-1 - Packaging for terminally sterilized medical devices cover?
BS EN ISO 11607-1 specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain the sterility of terminally sterilized medical devices until the point of use.
It applies to industry, to healthcare facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.
NOTE: BS EN ISO 11607-1:2020+A1:2023 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations. It does not describe a quality assurance system for control of all stages of manufacture. It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.
Why should you use BS EN ISO 11607-1 - 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, 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 11607-1:2020+A1:2023?
This is an amendment to BS EN ISO 11607-1:2019. The major changes in BS EN ISO 11607-1:2020+A1:2023 are around the expanded application of risk management, reflected in:
- A revised introduction
- Revisions to Clause 3, Clause 4.2 and Clause 6.1.1
- A new normative Annex F on risk management
- A new informative Annex G with guidance on packaging risk management