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DIN EN 13824

Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements; German version EN 13824:2004

inactive, Most Current
Organization: DIN
Publication Date: 1 February 2005
Status: inactive
Page Count: 64
ICS Code (Sterilization and disinfection in general): 11.080.01
scope:

Dieses Dokument legt Anforderungen an die Gestaltung und den Betrieb aseptischer Verarbeitungseinrichtungen und an die Validierung und Routinekontrolle der aseptischen Herstellungsverfahren für sterile flüssige Medizinprodukte fest. Es gilt nicht für pharmazeutische Produkte, für die Anforderungen an die einschlägige Gute Herstellungspraxis anzuwenden sind.

ANMERKUNG Viele der in diesem Dokument enthaltenen Prinzipien können auf bestimmte unter aseptischen Bedingungen hergestellte Medizinprodukte im festen Zustand angewendet werden.

Document History

DIN EN 13824
February 1, 2005
Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements; German version EN 13824:2004
Dieses Dokument legt Anforderungen an die Gestaltung und den Betrieb aseptischer Verarbeitungseinrichtungen und an die Validierung und Routinekontrolle der aseptischen Herstellungsverfahren für...
DIN EN 13824
December 1, 2002
Sterilization of medical devices - Validation and routine control of aseptic processes - Requirements and guidance; German version prEN 13824:2002
A description is not available for this item.
DIN EN 13824
April 1, 2000
Sterilization of medical devices - Validation and routine control of aseptic processes - Requirements and guidance; German version prEN 13824:2000
A description is not available for this item.

References

This document references:
EN 1174-1 - Sterilization of Medical Devices - Estimation of the Population of Micro-Organisms on Product - Part 1: Requirements
Published by CEN on February 1, 1996
A description is not available for this item.
This document references:
EN 980 - Symbols for use in the labelling of medical devices
Published by CEN on May 1, 2008
This European Standard specifies symbols for use in the information supplied by the manufacturer with medical devices. The requirements of this European Standard are not intended to apply to symbols...
This document references:
EN 1174-3 - Sterilization of Medical Devices - Estimation of the Population of Micro-Organisms on Product - Part 3: Guide to the Methods for Validation of Microbiological Techniques
Published by CEN on November 1, 1996
A description is not available for this item.
This document references:
EN ISO 14644-1 - Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
Published by CEN on December 1, 2015
This part of ISO 14644 specifies the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and clean zones; and separative devices as defined in ISO 14644-7....
This document references:
EN ISO 14698-2 - Cleanrooms and associated controlled environments -Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data
Published by CEN on September 1, 2003
A description is not available for this item.
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