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BSI - BS EN ISO 11607-2

Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes

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Organization: BSI
Publication Date: 31 May 2018
Status: inactive
Page Count: 26
ICS Code (Sterilized packaging): 11.080.30

Document History

BS EN ISO 11607-2 + A1
January 31, 2020
Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
A description is not available for this item.
BS EN ISO 11607-2
January 31, 2020
Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
A description is not available for this item.
BS EN ISO 11607-2 + A11
January 31, 2020
Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
A description is not available for this item.
BS EN ISO 11607-2
May 31, 2018
Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
A description is not available for this item.
BS EN ISO 11607-2
May 31, 2006
Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
A description is not available for this item.
BS EN ISO 11607-2
May 31, 2006
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
A description is not available for this item.
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References

This document references:
EN 868-5 - Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
Published by CEN on December 1, 2018
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...
This document references:
EN 868-8 - Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
Published by CEN on December 1, 2018
This document specifies test methods and values for re-usable containers used as sterile barrier systems that are intended to maintain sterility of terminally sterilized medical devices to the point...
This document references:
EN 13795-1 - Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
Published by CEN on April 1, 2019
This document specifies information to be supplied to users and third party verifiers in addition to the usual labelling of medical devices (see EN 1041 and EN ISO 15223-1), concerning manufacturing...
This document references:
EN 868-5 - Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
Published by CEN on December 1, 2018
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...
This document references:
EN 868-6 - Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
Published by CEN on February 1, 2017
This European Standard specifies test methods and values for paper used in the manufacture of preformed sterile barrier systems and/or packaging systems that are intended to maintain sterility of...
This document references:
EN 868-8 - Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
Published by CEN on December 1, 2018
This document specifies test methods and values for re-usable containers used as sterile barrier systems that are intended to maintain sterility of terminally sterilized medical devices to the point...
View Less
View All
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