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Norm
ÖNORM EN ISO 25424
Issue date: 2011 08 01
Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)
This European Standard specifies requirements for the development, validation and routine control of
a Low Temperature Steam and Formaldehyde (LTSF) sterilization proces...
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Withdrawn
: 2020 03 15
Publisher:
Austrian Standards International
Format:
Digital | 51 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
ICS
This European Standard specifies requirements for the development, validation and routine control of
a Low Temperature Steam and Formaldehyde (LTSF) sterilization process for medical devices.
This European Standard is intended to be applied by process developers, manufacturers of
sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with
responsibility for sterilizing medical devices. (See EN ISO 14937:2000, Table E.1)
This European Standard covers sterilization processes which use a mixture of low temperature steam
and formaldehyde as sterilant, and which are working below ambient pressure only.
ÖNORM EN ISO 25424
2022 10 01
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for de...
Norm
ÖNORM EN ISO 25424
2020 03 15
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for de...
Norm
ÖNORM EN ISO 25424
2011 08 01
Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for develop...
Norm
↖
ÖNORM EN 15424
2007 06 01
Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for develop...
Norm
Norm
ÖNORM EN ISO 11737-2
Issue date :
2010 04 01
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)
Norm
ÖNORM EN 14180
Issue date :
2009 12 15
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
Norm
ÖNORM EN ISO 11737-1
Issue date :
2011 01 15
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006 + Cor 1:2007) (consolidated version)
Norm
ÖNORM EN ISO 11138-1
Issue date :
2006 11 01
Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2006)
Norm
ÖNORM EN ISO 11138-5
Issue date :
2006 10 01
Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2006)
Norm
ÖNORM EN ISO 25424
Issue date :
2020 03 15
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)