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Norm
ÖNORM EN ISO 11135-1
Issue date: 2007 08 01
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
Diese ÖNORM legt Anforderungen für die Entwicklung, Validierung und Routineüberwachung eines Sterilisationsverfahrens mit Ethylenoxid für Medizinprodukte fest. Es sollte ...
Withdrawn: 2014 10 15
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 51 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
ICS
Diese ÖNORM legt Anforderungen für die Entwicklung, Validierung und Routineüberwachung eines Sterilisationsverfahrens mit Ethylenoxid für Medizinprodukte fest. Es sollte nicht vorausgesetzt werden, dass entsprechend den Anforderungen dieser Norm validierte und überwachte Sterilisationsverfahren bei der Inaktivierung der Erreger spongiformer Enzephalopathien wie Scrapie, bovine spongiforme Enzephalopathie und Creutzfeldt-Jakob-Krankheit wirksam sind. Diese Norm legt keine in den Einzelheiten festgelegte Anforderung zur Bezeichnung eines Medizinprodukts als steril fest. Sie legt kein Qualitätsmanagementsystem für die Überwachung aller Stufen der Herstellung von Medizinprodukten fest. Diese Norm legt keine Anforderungen an den Arbeitsschutz fest, die mit Gestaltung und Betrieb von Sterilisationsanlagen mit Ethylenoxid zusammen hängen und behandelt nicht die Sterilisation durch Einspritzen von Ethylenoxid oder dessen Gemischen direkt in Einzelpackungen mit Produkten oder ununterbrochene Sterilisationsverfahren. Dieses Dokument Norm behandelt nicht Analyseverfahren zur quantitativen Bestimmung restlich verbleibenden Ethylenoxids und/oder von dessen Reaktionsprodukten.
ÖNORM EN ISO 11135
2020 04 01
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validatio...
Norm
ÖNORM EN ISO 11135
2015 03 15
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validatio...
Norm
ÖNORM EN ISO 11135
2014 10 15
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validatio...
Norm
ÖNORM EN ISO 11135-1
2007 08 01
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, valid...
Norm
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ÖNORM EN 550
1994 09 01
Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization
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