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Norm
ÖNORM EN 14180
Issue date: 2014 09 15
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low
temperature steam and formaldehyde as sterilizing agent, and whi...
Valid
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 66 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low
temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only.
These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities.
This European Standard specifies minimum requirements:
- for the performance and design of sterilizers to ensure that the process is capable of sterilizing medical
devices;
- for the equipment and controls of these sterilizers necessary for the validation and routine control of the
sterilization processes.
ÖNORM EN 14180
2014 09 15
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements...
Norm
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ÖNORM EN 14180
2009 12 15
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements...
Norm
ÖNORM EN 14180
2003 10 01
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements...
Norm
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2009 09 15
Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
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2001 11 01
Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S
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2003 06 01
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2006 10 01
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2006 11 01
Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2006)
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