Jetzt anpassen und kaufen
143,05 €
exkl. USt.
Konfigurieren
Norm
ÖNORM EN ISO 13408-1
Ausgabedatum: 2014 01 01
Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 1: Allgemeine Anforderungen (ISO 13408-1:2008 + Amd 1:2013) (konsolidierte Fassung)
Der vorliegende Teil von ISO 13408 legt die allgemeinen Anforderungen an Verfahren, Programme und
Verfahrensweisen zur Entwicklung, Validierung und Routinekontrolle des ...
Weiterlesen
ZURÜCKGEZOGEN
: 2015 11 02
Herausgeber:
Austrian Standards International
Format:
Digital | 62 Seiten
Sprache:
Deutsch
| Englisch
| Download DE/EN
Aktuell Gültig:
Standards mitgestalten:
ICS
Der vorliegende Teil von ISO 13408 legt die allgemeinen Anforderungen an Verfahren, Programme und
Verfahrensweisen zur Entwicklung, Validierung und Routinekontrolle des Herstellungsverfahrens für aseptisch
hergestellte Produkte für die Gesundheitsfürsorge fest und stellt einen Leitfaden dafür zur Verfügung.
Der vorliegende Teil von ISO 13408 umfasst Anforderungen und einen Leitfaden in Bezug auf das
Gesamtthema der aseptischen Herstellung. Besondere Anforderungen und ein Leitfaden für verschiedene
spezielle Prozesse und Verfahren in Bezug auf Filtration, Lyophilisierung, Technologien der Reinigung vor Ort
(en: cleaning in place, CIP), Sterilisation vor Ort (en: sterilization in place, SIP) und Isolatorsysteme sind in
anderen Teilen von ISO 13408 angeführt.
ÖNORM EN ISO 13408-1
2015 11 01
Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 1: Allgemeine Anforderungen ...
Norm
ÖNORM EN ISO 13408-1
2014 01 01
Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 1: Allgemeine Anforderungen ...
Norm
↖
ÖNORM EN ISO 13408-1
2011 09 15
Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 1: Allgemeine Anforderungen ...
Norm
ÖNORM EN 13824
2005 02 01
Sterilisation von Medizinprodukten - Aseptische Herstellung flüssiger Medizinprodukte - Anforderunge...
Norm
Norm
ISO 11137-1:2006
Ausgabedatum :
2006 04 19
Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
Norm
ISO 11137-2:2013
Ausgabedatum :
2013 05 21
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Norm
ISO 13408-2:2003
Ausgabedatum :
2003 03 26
Aseptic processing of health care products — Part 2: Filtration
Norm
ISO 13408-3:2006
Ausgabedatum :
2006 09 01
Aseptic processing of health care products — Part 3: Lyophilization
Norm
ISO 13408-4:2005
Ausgabedatum :
2005 10 28
Aseptic processing of health care products — Part 4: Clean-in-place technologies
Norm
ISO 13408-5:2006
Ausgabedatum :
2006 11 15
Aseptic processing of health care products — Part 5: Sterilization in place
Schlussentwurf
ISO/FDIS 13485
Ausgabedatum :
2015 10 29
Medical devices — Quality management systems — Requirements for regulatory purposes
Norm
ISO 13485:2003
Ausgabedatum :
2003 07 03
Medical devices — Quality management systems — Requirements for regulatory purposes
Norm
ISO 14160:2011
Ausgabedatum :
2011 07 01
Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
Norm
ISO 14644-5:2004
Ausgabedatum :
2004 08 13
Cleanrooms and associated controlled environments — Part 5: Operations
Schlussentwurf
ISO/FDIS 14644-2
Ausgabedatum :
2015 08 27
Cleanrooms and associated controlled environments — Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
Norm
ISO 14644-2:2000
Ausgabedatum :
2000 09 07
Cleanrooms and associated controlled environments — Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1
Norm
ISO 14644-3:2005
Ausgabedatum :
2005 12 06
Cleanrooms and associated controlled environments — Part 3: Test methods
Norm
ISO 14644-4:2001
Ausgabedatum :
2001 04 12
Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
Norm
ISO 14971:2007
Ausgabedatum :
2007 02 28
Medical devices — Application of risk management to medical devices (Corrected version 2007-09)
Norm
ISO 20857:2010
Ausgabedatum :
2010 08 17
Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
Norm
ISO 14644-7:2004
Ausgabedatum :
2004 10 07
Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
Norm
ISO 14698-1:2003
Ausgabedatum :
2003 09 17
Cleanrooms and associated controlled environments — Biocontamination control — Part 1: General principles and methods
Norm
ISO 14937:2009
Ausgabedatum :
2009 10 14
Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
Norm
ISO 17665-1:2006
Ausgabedatum :
2006 08 17
Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Norm
ISO 11135-1:2007
Ausgabedatum :
2007 04 27
Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (Corrected version 2007-10)
Norm
ISO 11137-1:2006
Ausgabedatum :
2006 04 19
Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
Norm
ISO 11137-2:2013
Ausgabedatum :
2013 05 21
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Norm
ISO 13408-2:2018
Ausgabedatum :
2018 01 09
Aseptic processing of health care products — Part 2: Sterilizing filtration
Norm
ISO 13408-3:2006
Ausgabedatum :
2006 09 01
Aseptic processing of health care products — Part 3: Lyophilization
Norm
ISO 13408-4:2005
Ausgabedatum :
2005 10 28
Aseptic processing of health care products — Part 4: Clean-in-place technologies
Norm
ISO 13408-5:2006
Ausgabedatum :
2006 11 15
Aseptic processing of health care products — Part 5: Sterilization in place
Norm
ISO 13485:2016
Ausgabedatum :
2016 02 25
Medical devices — Quality management systems — Requirements for regulatory purposes
Norm
ISO 14160:2020
Ausgabedatum :
2020 09 21
Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
Norm
ISO 14644-1:1999
Ausgabedatum :
1999 05 06
Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness
Norm
ISO 14644-2:2015
Ausgabedatum :
2015 12 09
Cleanrooms and associated controlled environments — Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
Norm
ISO 14644-3:2019
Ausgabedatum :
2019 08 30
Cleanrooms and associated controlled environments — Part 3: Test methods (Corrected version 2020-06)
Norm
ISO 14644-4:2001
Ausgabedatum :
2001 04 12
Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
Norm
ISO 14644-5:2004
Ausgabedatum :
2004 08 13
Cleanrooms and associated controlled environments — Part 5: Operations
Norm
ISO 14644-7:2004
Ausgabedatum :
2004 10 07
Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
Norm
ISO 14698-1:2003
Ausgabedatum :
2003 09 17
Cleanrooms and associated controlled environments — Biocontamination control — Part 1: General principles and methods
Norm
ISO 14937:2009
Ausgabedatum :
2009 10 14
Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
Norm
ISO 14971:2019
Ausgabedatum :
2019 12 10
Medical devices — Application of risk management to medical devices
Norm
ISO 17665-1:2006
Ausgabedatum :
2006 08 17
Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Norm
ISO 20857:2010
Ausgabedatum :
2010 08 17
Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
Norm
ÖNORM EN ISO 13408-1
Ausgabedatum :
2015 11 01
Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 1: Allgemeine Anforderungen (ISO 13408-1:2008, einschließlich Amd 1:2013)
Norm
ISO 13408-1:2008
Ausgabedatum :
2008 06 10
Aseptic processing of health care products — Part 1: General requirements