DIN EN 868-5:2009 PDF

Scope: This part of EN 868 provides test methods and values for sealable pouches and reels manufactured from porous materials complying with either EN 868 part 2, 3, 6, 7, 9 or 10 and plastic film complying with Clause 4 used as 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 by this 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 4.5 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. The materials specified in this part of EN 868 are intended for single use only. NOTE 2 When additional materials are used inside the sterile barder 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.

DIN EN 868-5:2009 Referenced Document

EN 868-2 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods*， 2017-02-01 Update
EN 868-3 Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods*， 2017-02-01 Update
EN 868-6 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods*， 2017-02-01 Update
EN 868-7 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods*， 2017-02-01 Update
EN 868-9 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
EN ISO 11140-1 Sterilization of health care products - Chemical indicators - Part 1: General requirements*， 2014-11-01 Update
EN ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials@ sterile barrier systems and packaging systems
ISO 8601 Data elements and interchange formats - Information interchange - Representation of dates and times

2019 DIN EN 868-5:2019-03 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods; German version EN 868-5:2018
2019 DIN EN 868-5:2019 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
1970 DIN EN 868-5 E:2017-08 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
2017 DIN EN 868-5 E:2017 Draft Document - Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods; German and English version prEN 868-5:2017
2009 DIN EN 868-5:2009 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods;English version of DIN EN 868-5:2009-09
1999 DIN EN 868-5:2002 Packaging materials and systems for medical devices to be sterilized Part 5: Heat- and self-sealable transparent bags and tubes made of paper and plastic composite film — requirements and test methods