Standard

NEN-EN-ISO 11135:2004 Ontw. en

Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices

  • This norm is withdrawn since 28-09-2011

41,62 50,36 Incl BTW

About norm

Status Withdrawn
Number of pages 53
Published on 01-06-2004
Language English
This part of ISO 11135 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices. NOTE 1 Although the scope of this part of ISO 11135 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other health care products. Sterilization processes validated and controlled in accordance with the requirements of this part of ISO 11135 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.

Details

ICS-code 11.080.01
Dutch title Sterilisatie van producten voor de gezondheidszorg - Ethyleenoxide - Eisen voor de ontwikkeling, validatie en routine controle van een sterilisatieproces voor medische hulpmiddelen
English title Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices
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