This part of the series of EN 868 provides examples of particular requirements and test methods for sterilization wrap suitable for use as packaging of medical devices which are to be terminally sterilized. 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 4.5 can be used to demonstrate compliance with one or more but not all of the requirements of Part 1.
NOTE If the intended use as specified by the manufacturer includes the possibility of the material being used for other applications (e.g. sterile field, container filter or as an inner wrap for containers), then additional and/or other requirements can apply.
BS EN 868-2:1999 history
2017BS EN 868-2:2017 Packaging for terminally sterilized medical devices. Sterilization wrap. Requirements and test methods
2009BS EN 868-2:2009 Packaging for terminally sterilized medical devices - Sterilization wrap - Requirements and test methods
1999BS EN 868-2:1999 Packaging materials and systems for medical devices which are to be sterilized - Sterilization wrap - Requirements and test methods