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BSI - BS EN ISO 11607-2 - TC

Tracked Changes (Redline) - Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes

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Organization: BSI
Publication Date: 12 November 2020
Status: active
Page Count: 54
ICS Code (Sterilized packaging): 11.080.30

Document History

BS EN ISO 11607-2 - TC
November 12, 2020
Tracked Changes (Redline) - 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 - TC
August 9, 2019
Tracked Changes (Redline) - Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
A description is not available for this item.

References

This document references:
DIN 58953-8 - Sterilisation - Sterilgutversorgung - Teil 8: Logistik von sterilen Medizinprodukten
Published by DIN on March 1, 2019
Dieses Dokument legt Anforderungen an die Logistik steriler Medizinprodukte innerhalb von Einrichtungen der Gesundheitsfürsorge zum Erhalt der Qualität bis zur aseptischen Anwendung fest. Dieses...
This document references:
DIN 58953-7 - Sterilisation - Sterilgutversorgung - Teil 7: Anwendungstechnik von Sterilisationspapier, Vliesstoffen, Papierbeuteln und siegelfaehigen Klarsichtbeuteln und -schlaeuchen
Published by DIN on November 1, 2020
A description is not available for this item.
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 868-8 - 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:
DIN 58953-7 - Sterilisation - Sterilgutversorgung - Teil 7: Anwendungstechnik von Sterilisationspapier, Vliesstoffen, Papierbeuteln und siegelfaehigen Klarsichtbeuteln und -schlaeuchen
Published by DIN on November 1, 2020
A description is not available for this item.
This document references:
DIN 58953-8 - Sterilisation - Sterilgutversorgung - Teil 8: Logistik von sterilen Medizinprodukten
Published by DIN on March 1, 2019
Dieses Dokument legt Anforderungen an die Logistik steriler Medizinprodukte innerhalb von Einrichtungen der Gesundheitsfürsorge zum Erhalt der Qualität bis zur aseptischen Anwendung fest. Dieses...
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