BS EN ISO 11607-1:2020+A11:2022
Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes
- Standard No.
- BS EN ISO 11607-1:2020+A11:2022
- Published By
- British Standards Institution (BSI)
- Status
- 2023-11
- Replace By
- BS EN ISO 11607-1:2020+A1:2023
- Latest
- BS EN ISO 11607-1:2020+A1:2023
- Scope
- This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use. It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized. It 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.
BS EN ISO 11607-1:2020+A11:2022 history
- 2023 BS EN ISO 11607-1:2020+A1:2023 Packaging for terminally sterilized medical devices - Requirements for materials, sterile barrier systems and packaging systems
- 1970 BS EN ISO 11607-1:2020+A11:2022 Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes
- 1970 BS EN ISO 11607-1:2020 Packaging for terminally sterilized medical devices - Requirements for materials, sterile barrier systems and packaging systems
- 1970 BS EN ISO 11607-1:2017 Packaging for terminally sterilized medical devices - Requirements for materials, sterile barrier systems and packaging systems
- 2014 BS EN ISO 11607-1:2009+A1:2014 Packaging for terminally sterilized medical devices-Requirements for materials, sterile barrier systems and packaging systems
- 2010 BS EN ISO 11607-1:2010 Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems
- 2010 BS EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices - Requirements for materials, sterile barrier systems and packaging systems
- 2006 BS EN ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Requirements for materials, sterile barrier systems and packaging systems
- 1997 BS EN 868-1:1997 Packaging materials and systems for medical devices which are to be sterilized - General requirements and test methods
