BS EN 868-8:1999 PDF

Scope: This part of the series of EN 868 provides examples of particular requirements and test methods for re-usable containers for steam sterilization. It introduces no additional requirements to the general requirements of Part 1 but provides guidance based upon various elements of former, relevant national standards. As such, the particular requirements in 4.2 to 4.7 can be used to demonstrate compliance with one or more but not all of the requirements of Part 1. The containers specified in this part of the standard are intended to be used as a packaging system during the sterilization of medical devices in steam sterilizers conforming to EN 285 and the subsequent transportation and storage of those devices. NOTE 1 When it is intended to use the containers in a steam sterilizer not conforming to EN 285 the sterilization performance of the container in the specific sterilization cycle to be used is validated by the user. Other attributes of the container are also reviewed for compatibility with the sterilizer cycle e.g. operating temperature. NOTE 2 When goods are required to be multiple wrapped in order to fulfil the general requirements, they should first be packaged in a sterilization packaging material (e.g. a material as specified in other parts of this series of standards).

BS EN 868-8:1999 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