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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...
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Publisher:
Austrian Standards International
Format:
Digital | 66 Pages
Language:
German
| English
| Download GER/ENG
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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
Norm
ÖNORM EN 868-5
Issue date :
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
Norm
ÖNORM EN 867-5
Issue date :
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
Norm
ÖNORM EN ISO 228-1
Issue date :
2003 06 01
Pipe threads where pressure-tight joints are not made on the threads - Part 1: Dimensions, tolerances and designation (ISO 228-1:2000)
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 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 3746
Issue date :
2011 03 01
Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Survey method using an enveloping measurement surface over a reflecting plane (ISO 3746:2010)
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ÖNORM EN ISO 14971
Issue date :
2013 03 01
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
Norm
ÖNORM EN ISO 16396-1
Issue date :
2015 05 01
Plastics - Polyamide (PA) moulding and extrusion materials - Part 1: Designation system, marking of products and basis for specifications (ISO 16396-1:2015)
Norm
ÖNORM EN ISO 15223-1
Issue date :
2012 10 15
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012)