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Norm
ÖNORM EN ISO 14937
Issue date: 2010 03 15
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 (ISO 14937:2009)
This International Standard specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and ...
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Publisher:
Austrian Standards International
Format:
Digital | 51 Pages
Language:
German
| English
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This International Standard specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices. This International Standard applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means. This International Standard is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized, and organizations responsible for sterilizing medical devices.
ÖNORM EN ISO 14937
2010 03 15
Sterilization of health care products - General requirements for characterization of a sterilizing a...
Norm
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ÖNORM EN ISO 14937
2005 07 01
Sterilization of health care products - General requirements for characterization of a sterilizing a...
Norm
ÖNORM EN ISO 14937
2004 06 01
Sterilization of health care products - General requirements for characterization of a sterilizing a...
Norm
ÖNORM EN ISO 14937
2001 09 01
Sterilization of health care products - General requirements for characterization of a sterilizing a...
Norm
Norm
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2003 04 14
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2009 10 13
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ISO 10993-17:2002
Issue date :
2002 11 27
Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
Norm
ISO 11140-1:2005
Issue date :
2005 07 20
Sterilization of health care products — Chemical indicators — Part 1: General requirements
Norm
ISO 11737-1:2006
Issue date :
2006 03 20
Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products (Corrected version 2006-03)
Norm
ISO 11737-2:2009
Issue date :
2009 11 06
Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
Norm
ISO 10012:2003
Issue date :
2003 04 14
Measurement management systems — Requirements for measurement processes and measuring equipment
Norm
ISO 10993-17:2002
Issue date :
2002 11 27
Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
Norm
ISO 11138-1:2006
Issue date :
2006 06 26
Sterilization of health care products — Biological indicators — Part 1: General requirements
Norm
ISO 11140-1:2014
Issue date :
2014 10 31
Sterilization of health care products — Chemical indicators — Part 1: General requirements
Norm
ISO 11737-1:2018
Issue date :
2018 01 12
Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
Norm
ISO 11737-2:2019
Issue date :
2019 12 02
Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
Norm
ISO 13485:2003
Issue date :
2003 07 03
Medical devices — Quality management systems — Requirements for regulatory purposes
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