- Standard No.
- EN 868-9:2009
- Release Date
- 2009
- Published By
- European Committee for Standardization (CEN)
- Latest
-
EN 868-9:2009
- Replace
-
BS EN 455-2:2009
- Scope
- This part of EN 868 provides test methods and values for uncoated nonwoven materials of polyolefines used for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. NOTE 1 The need for a protective packaging may be determined by the manufacturer and the user.This part of EN 868 only introduces performance requirements and test methods that are specific to the products covered byThis part of EN 868 but does not add or modify the general requirements specified in EN ISO 11607-1. As such; the particular requirements in 4.2 to 4.3 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. NOTE 2 When additional materials are used inside the sterile barrier system in order to ease the organization; drying or aseptic presentation (e. g. inner wrap; container filter; indicators; packing lists; mats; instrument organizer sets; tray liners or an additional envelope around the medical device) then other requirements; including the determination of the acceptability of these materials during validation activities; may apply. The materials specified inThis part of EN 868 are intended for single use only.
EN 868-9:2009 Referenced Document
- ISO 188 Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests*， 2023-03-09 Update
- ISO 23529:2004 Rubber - General procedures for preparing and conditioning test pieces for physical test methods
EN 868-9:2009 history
- 2009 EN 868-9:2009 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
- 2000 EN 868-9:2000 Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 9: Uncoated Nonwoven Materials of Polyolefines for Use in the Manufacture of Heat Sealable Pouches, Reels and Lids - Requirements and Test Methods
EN 868-9:2009 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods has been changed from BS EN 455-2:2009 Medical gloves for single use - Requirements and testing for physical properties.