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Norm
ÖNORM EN 868-5
Issue date: 2009 09 15
Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
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 ...
Withdrawn: 2019 02 01
Publisher:
Austrian Standards International
Format:
Digital | 19 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
ICS
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.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.
ÖNORM EN 868-5
2019 02 01
Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous m...
Norm
ÖNORM EN 868-5
2009 09 15
Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous m...
Norm
↖
ÖNORM EN 868-5/AC
2002 01 01
Packaging materials and systems for medical devices which are to be sterilized - Part 5: Heat and se...
Norm
ÖNORM EN 868-5
1999 10 01
Packaging materials and systems for medical devices which are to be sterilized - Part 5: Heat and se...
Norm
Norm
Issue date :
2004 12 03
Data elements and interchange formats — Information interchange — Representation of dates and times
Norm
Issue date :
2009 09 15
Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
Norm
Issue date :
2009 09 15
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
Norm
Issue date :
2009 09 15
Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
Norm
Issue date :
2009 09 15
Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
Norm
Issue date :
2009 09 15
Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
Norm
Issue date :
2009 09 15
Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
Norm
Issue date :
2009 10 15
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)
Norm
Issue date :
2007 06 01
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
Norm
Issue date :
2004 12 03
Data elements and interchange formats — Information interchange — Representation of dates and times
Norm
Issue date :
2018 08 01
Standard Test Method for Tensile Properties of Thin Plastic Sheeting
Norm
Issue date :
2019 02 01
Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
