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Norm

ISO 11135-1:2007

Ausgabedatum: 2007 04 27

Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (Corrected version 2007-10)

ISO 11135-1:2007 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices. Sterilization ...
ZURÜCKGEZOGEN: 2014 07 07
Herausgeber:
International Organization for Standardization
Format:
Digital | 41 Seiten
Sprache:
Englisch
Aktuell Gültig:

ISO 11135-1:2007 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices.

Sterilization processes validated and controlled in accordance with the requirements of ISO 11135-1:2007 are not assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld Jacob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

ISO 11135:2014
2014 07 07
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validatio...
Norm
ISO 11135-1:2007
2007 04 27
Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, valid...
Norm
ISO 11135:1994/Cor 1:1994
1994 10 27
Medical devices — Validation and routine control of ethylene oxide sterilization — Technical Corrige...
Norm
ISO 11135:1994
1994 01 27
Medical devices — Validation and routine control of ethylene oxide sterilization
Norm
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Norm
ISO 11135:2014
Ausgabedatum : 2014 07 07
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices