Norm

NEN-EN 15424:2005 Ontw. en

Sterilisatie van medische hulpmiddelen - Ontwikkeling, validatie en routine controle van sterilisatieprocessen - Lage-temperatuur stoom en formaldehyde

  • Deze norm is ingetrokken sinds 20-04-2007

35,70

Over deze norm

Status Ingetrokken
Aantal pagina's 46
Gepubliceerd op 01-11-2005
Taal Engels
This European Standard specifies requirements for the development, validation and routine control of a Low Temperature Steam and Formaldehyde (LTSF) sterilization process for medical devices. NOTE Although the scope of this standard is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment. Manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organisations with responsibility for sterilizing medical devices. (See EN ISO 14937: 2000 Annex E, Table E.1) This European standard covers sterilization processes which use a mixture of low temperature steam and formaldehyde as sterilant, and which are working below ambient pressure only. 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 specify requirements for designating a medical device as "STERILE". Such requirements are given in EN 556-1. 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 LTSF sterilization facilities. This European standard does not cover analytical methods for determining levels or residues of formaldehyde and/or its reaction products. This European standard does not cover preparatory measures that may be needed before sterilization such as cleaning, disinfection and packing.

Details

ICS-code 11.080.10
Nederlandse titel Sterilisatie van medische hulpmiddelen - Ontwikkeling, validatie en routine controle van sterilisatieprocessen - Lage-temperatuur stoom en formaldehyde
Engelse titel Sterilization of medical devices - Development, validation and routine control of sterilization processes - Low temperature Steam and Formaldehyde
Vervangen door
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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