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Norm
ÖNORM EN ISO 11140-1
Issue date: 2015 02 01
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
This part of ISO 11140 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical c...
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§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 40 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
This part of ISO 11140 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the process parameter(s) specified for a sterilization process. They are not dependent for their action on the presence or absence of a living organism.
The requirements and test methods of this part of ISO 11140 apply to all indicators specified in subsequent parts of ISO 11140, unless the requirement is modified or added to by a subsequent part, in which case the requirement of that particular part will apply.
Relevant test equipment is described in ISO 18472.
ÖNORM EN ISO 11140-1
2015 02 01
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 1114...
Norm
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ÖNORM EN ISO 11140-1
2009 10 15
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 1114...
Norm
ÖNORM EN ISO 11140-1
2007 10 01
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 1114...
Norm
ÖNORM EN ISO 11140-1
2006 04 01
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 1114...
Norm
ÖNORM EN 867-1
1997 09 01
Non-biological systems for use in sterilizers - Part 1: General requirements
Norm
ÖNORM EN 867-2
1997 09 01
Non-biological systems for use in sterilizers - Part 2: Process indicators (Class A)
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2006 06 26
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2006 06 26
Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
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2006 06 26
Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
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2006 06 26
Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes
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2006 06 26
Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
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2007 03 15
Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
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2007 03 15
Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
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Issue date :
2007 03 15
Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
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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
Technische Regel
Issue date :
2009 01 05
Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1
Technische Regel
Issue date :
2013 04 12
Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
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Issue date :
2014 10 31
Sterilization of health care products — Chemical indicators — Part 1: General requirements
