BS EN 868-8:2018 PDF

Scope: What is BS EN 868‑8- Requirements and test methods for re-usable sterilization containers for steam sterilizers about? BS EN 868‑8 discusses packaging for terminally sterilized medical devices. BS EN 868‑8 is an international standard on requirements and test methods for re-usable sterilization containers for steam sterilizers to assure the sterility of the medical devices. BS EN 868‑8 is the eighth part of the BS EN 868 series on packaging for terminally sterilized medical devices that specifies test methods and values for re-usable containers used as sterile barrier systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. These containers are intended to be used in steam sterilizers conforming to EN 285. Other than the general requirements as specified in EN ISO 11607‑1 and EN ISO 11607‑2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by BS EN 868‑8. Note1: The use of additional materials and/or accessories inside the sterile barrier system to ease the organization, drying, or aseptic presentation (e.g., inner wrap, indicators, packing lists, mats, instrument organizer sets, tray liners, or an additional envelope around the medical device) is not covered in EN 868-8 . However, other requirements, including the determination of the acc...

BS EN 868-8:2018 history

2019 BS EN 868-8:2018 Packaging for terminally sterilized medical devices. Re-usable sterilization containers for steam sterilizers conforming to EN 285. Requirements and test methods
2009 BS EN 868-8:2009 Packaging for terminally sterilized medical devices - Re-usable sterilization containers for steam sterilizers conforming to EN 285: Requirements and test methods
1999 BS EN 868-8:1999 Packaging materials and systems for medical devices which are to be sterilized - Re-usable sterilization containers for steam sterilizers conforming to EN 285: Requirements and test methods