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DIN 58953-8

Sterilisation - Sterilgutversorgung - Teil 8: Logistik von sterilen Medizinprodukten

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Organization: DIN
Publication Date: 1 March 2019
Status: active
Page Count: 10
ICS Code (Sterilized packaging): 11.080.30
scope:

Dieses Dokument legt Anforderungen an die Logistik steriler Medizinprodukte innerhalb von Einrichtungen der Gesundheitsfürsorge zum Erhalt der Qualität bis zur aseptischen Anwendung fest.

Dieses Dokument gilt nicht für die Logistik steriler Medizinprodukte auBerhalb von Einrichtungen der Gesundheitsfürsorge (Dienstleistungsbetriebe, z. B. medizinischer Sanitätsfachhandel und Distributionszentren). Anforderungen hierfür sind u. a. DIN EN ISO 11607-1 und DIN EN ISO 11607-2 zu entnehmen

Document History

DIN 58953-8
March 1, 2019
Sterilisation - Sterilgutversorgung - Teil 8: Logistik von sterilen Medizinprodukten
Dieses Dokument legt Anforderungen an die Logistik steriler Medizinprodukte innerhalb von Einrichtungen der Gesundheitsfürsorge zum Erhalt der Qualität bis zur aseptischen Anwendung fest. Dieses...
DIN 58953-8
September 1, 2018
Sterilization - Sterile supply - Part 8: Logistics of sterile medical devices
A description is not available for this item.
DIN 58953-8
May 1, 2010
Sterilization - Sterile supply - Part 8: Logistics of sterile medical devices
A description is not available for this item.
DIN 58953-8
November 1, 2008
Sterilization - Sterile supply - Part 8: Logistics of sterile medical devices
A description is not available for this item.
DIN 58953-8
October 1, 2003
Sterilization - Sterile supply - Part 8: Logistics of sterile medical devices
A description is not available for this item.
DIN 58953-8
March 1, 2002
Sterilization - Sterile supply - Part 8: Logistics of sterile medical devices
A description is not available for this item.
DIN 58953-8
February 1, 1993
Sterilization; sterile supply; delivering of sterile medical devices for single use as well as its storage and handling
A description is not available for this item.
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References

This document references:
DIN 1946-4 - Ventilation and air conditioning - Part 4: Ventilation in buildings and rooms of health care
Published by DIN on September 1, 2018
Diese Norm gilt für Planung, Bau, Abnahme und Betrieb raumlufttechnischer Anlagen (RLT-Anlagen) in Gebäuden und Räumen für das Gesundheitswesen, in denen medizinische Untersuchungen, Behandlungen und...
This document references:
DIN EN ISO 11607-1 - Verpackungen fuer in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1: Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme (ISO 11607-1:2019); Deutsche Fassung EN ISO 11607-1:2020
Published by DIN on May 1, 2020
A description is not available for this item.
This document references:
DIN EN ISO 11607-2 - Verpackungen fuer in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2: Validierungsanforderungen an Prozesse der Formgebung, Siegelung und des Zusammenstellens (ISO 11607-2:2019); Deutsche Fassung EN ISO 11607-2:2020
Published by DIN on May 1, 2020
A description is not available for this item.
This document is referenced by:
BS EN ISO 11607-2 - Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
Published by BSI on January 31, 2020
A description is not available for this item.
This document is referenced by:
AAMI 11607-2 - Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing, and assembly processes
Published by AAMI on January 1, 2019
This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and...
This document is referenced by:
PD CEN ISO/TS 16775 - Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2
Published by BSI on November 30, 2021
A description is not available for this item.
This document is referenced by:
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
Published by BSI on November 12, 2020
A description is not available for this item.
This document is referenced by:
ISO 11607-2 - Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
Published by ISO on February 1, 2019
This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and...
This document is referenced by:
TS 16775 - Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2
Published by ISO on November 1, 2021
This document provides guidance for the application of the requirements contained in ISO 11607-1 and ISO 11607-2. It does not add to, or otherwise change, the requirements of ISO 11607-1 and ISO...
This document is referenced by:
EN ISO 11607-2 - Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
Published by CEN on January 1, 2020
This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and...
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