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Norm
ÖNORM EN ISO 11137-2
Issue date: 2007 10 01
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01)
Dieser Teil der Internationale Norm 11137 legt Verfahren zur Ermittlung der Mindestdosis, die zur Erreichung einer festgelegten Anforderung an die Sterilität erforderlic...
Withdrawn: 2012 06 01
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 73 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
ICS
Dieser Teil der Internationale Norm 11137 legt Verfahren zur Ermittlung der Mindestdosis, die zur Erreichung einer festgelegten Anforderung an die Sterilität erforderlich ist, und Verfahren zur Bestätigung der Anwendung von 25 kGy oder 15 kGy als Sterilisationsdosis zur Erreichung eines Sterilitätssicherheitsniveaus, SAL, von 10-6 fest. Er legt auch Verfahren der Dosisüberprüfung zum Nachweis der fortgesetzten Wirksamkeit der Sterilisationsdosis fest. Dieser Teil der Internationale Norm 11137 definiert Produktfamilien für die Dosisfestlegung und Dosisüberprüfung.
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ÖNORM EN ISO 11137-2
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Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO...
Norm
ÖNORM EN ISO 11137-2
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ÖNORM EN ISO 11137-2
2006 07 01
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO...
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ÖNORM EN 552/A2
2001 03 01
Sterilization of medical devices - Validation and routine control of sterilization by irradiation (A...
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ÖNORM EN 552/A1
1999 10 01
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ÖNORM EN 552
1994 09 01
Sterilization of medical devices - Validation and routine control of sterilization irradiation
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