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Norm
ÖNORM EN 868-5
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
This document specifies 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 an...
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Publisher:
Austrian Standards International
Format:
Digital | 22 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
This document specifies 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. These sealable pouches and reels are 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.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.
The materials specified in this part of EN 868 are intended for single use only.
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