Norm

NEN-EN-ISO 17665:2004 Ontw. en

Sterilisatie van producten voor de gezondheidszorg - Stoom - Ontwikkeling, validatie en routine controle van een sterilisatieproces voor medische hulpmiddelen

  • Deze norm is ingetrokken sinds 28-09-2006

44,69

Over deze norm

Status Ingetrokken
Aantal pagina's 64
Gepubliceerd op 01-08-2004
Taal Engels
This International Standard specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices. Moist heat sterilization processes covered by this standard include but are not limited to: a) saturated steam venting systems; b) saturated steam active air removal systems; c) air steam mixtures; d) water spray; and e) water immersion. Sterilization processes validated and controlled in accordance with the requirements of this standard should not be assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. This standard does not apply to those sterilization processes that are based on a combination of moist heat with other biocidal agents (e.g. formaldehyde) as the sterilizing agent. This standard does not detail a specified requirement for designating a medical device as "sterile." This standard does not specify a quality management system for the control of all stages of production of medical devices. This standard does not specify requirements for occupational safety associated with the design and operation of moist heat sterilization facilities.

Details

ICS-code 11.080.01
Nederlandse titel Sterilisatie van producten voor de gezondheidszorg - Stoom - Ontwikkeling, validatie en routine controle van een sterilisatieproces voor medische hulpmiddelen
Engelse titel Sterilization of health care products - Moist heat - Development, validation and routine control of a sterilization process for medical devices
Vervangt
Vervangen door
Normatieve verwijzingen
  • 98/79/EG, In vitro diagnostica

Winkelwagen

Subtotaal:

Ga naar winkelwagen