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Norm
ÖNORM EN ISO 13408-1
Issue date: 2014 01 01
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008 + Amd 1:2013) (consolidated version)
This part of ISO 13408 specifies the general requirements for, and offers guidance on, processes,
programmes and procedures for development, validation and routine contr...
Read more
Withdrawn
: 2015 11 01
Publisher:
Austrian Standards International
Format:
Digital | 62 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
ICS
This part of ISO 13408 specifies the general requirements for, and offers guidance on, processes,
programmes and procedures for development, validation and routine control of the manufacturing process for
aseptically-processed health care products.
This part of ISO 13408 includes requirements and guidance relative to the overall topic of aseptic
processing. Specific requirements and guidance on various specialized processes and methods related to
filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are
given in other parts of ISO 13408.
ÖNORM EN ISO 13408-1
2015 11 01
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, includi...
Norm
ÖNORM EN ISO 13408-1
2014 01 01
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008 + Amd 1:...
Norm
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ÖNORM EN ISO 13408-1
2011 09 15
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008)
Norm
ÖNORM EN 13824
2005 02 01
Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
Norm
Norm
ISO 11137-1:2006
Issue date :
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
Issue date :
2013 05 21
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Norm
ISO 13408-2:2003
Issue date :
2003 03 26
Aseptic processing of health care products — Part 2: Filtration
Norm
ISO 13408-3:2006
Issue date :
2006 09 01
Aseptic processing of health care products — Part 3: Lyophilization
Norm
ISO 13408-4:2005
Issue date :
2005 10 28
Aseptic processing of health care products — Part 4: Clean-in-place technologies
Norm
ISO 13408-5:2006
Issue date :
2006 11 15
Aseptic processing of health care products — Part 5: Sterilization in place
Final Draft
ISO/FDIS 13485
Issue date :
2015 10 29
Medical devices — Quality management systems — Requirements for regulatory purposes
Norm
ISO 13485:2003
Issue date :
2003 07 03
Medical devices — Quality management systems — Requirements for regulatory purposes
Norm
ISO 14160:2011
Issue date :
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
Issue date :
2004 08 13
Cleanrooms and associated controlled environments — Part 5: Operations
Final Draft
ISO/FDIS 14644-2
Issue date :
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
Issue date :
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
Issue date :
2005 12 06
Cleanrooms and associated controlled environments — Part 3: Test methods
Norm
ISO 14644-4:2001
Issue date :
2001 04 12
Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
Norm
ISO 14971:2007
Issue date :
2007 02 28
Medical devices — Application of risk management to medical devices (Corrected version 2007-09)
Norm
ISO 20857:2010
Issue date :
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
Issue date :
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
Issue date :
2003 09 17
Cleanrooms and associated controlled environments — Biocontamination control — Part 1: General principles and methods
Norm
ISO 14937:2009
Issue date :
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
Issue date :
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
Issue date :
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
Issue date :
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
Issue date :
2013 05 21
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Norm
ISO 13408-2:2018
Issue date :
2018 01 09
Aseptic processing of health care products — Part 2: Sterilizing filtration
Norm
ISO 13408-3:2006
Issue date :
2006 09 01
Aseptic processing of health care products — Part 3: Lyophilization
Norm
ISO 13408-4:2005
Issue date :
2005 10 28
Aseptic processing of health care products — Part 4: Clean-in-place technologies
Norm
ISO 13408-5:2006
Issue date :
2006 11 15
Aseptic processing of health care products — Part 5: Sterilization in place
Norm
ISO 13485:2016
Issue date :
2016 02 25
Medical devices — Quality management systems — Requirements for regulatory purposes
Norm
ISO 14160:2020
Issue date :
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
Issue date :
1999 05 06
Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness
Norm
ISO 14644-2:2015
Issue date :
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
Issue date :
2019 08 30
Cleanrooms and associated controlled environments — Part 3: Test methods (Corrected version 2020-06)
Norm
ISO 14644-4:2001
Issue date :
2001 04 12
Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
Norm
ISO 14644-5:2004
Issue date :
2004 08 13
Cleanrooms and associated controlled environments — Part 5: Operations
Norm
ISO 14644-7:2004
Issue date :
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
Issue date :
2003 09 17
Cleanrooms and associated controlled environments — Biocontamination control — Part 1: General principles and methods
Norm
ISO 14937:2009
Issue date :
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
Issue date :
2019 12 10
Medical devices — Application of risk management to medical devices
Norm
ISO 17665-1:2006
Issue date :
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
Issue date :
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
Issue date :
2015 11 01
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
Norm
ISO 13408-1:2008
Issue date :
2008 06 10
Aseptic processing of health care products — Part 1: General requirements