Norm

NEN-EN 15424:2007 en

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

  • Deze norm is ingetrokken sinds 01-07-2011

74,30

Over deze norm

Status Ingetrokken
Aantal pagina's 46
Gepubliceerd op 01-04-2007
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. This European Standard is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices. (See EN ISO 14937:2000, 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.

Details

ICS-code 11.080.10
Nederlandse titel Sterilisatie van medische hulpmiddelen - Lage-temperatuur stoom en formaldehyde - Ontwikkeling, validatie en routine controle van sterilisatieprocessen
Engelse titel Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
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Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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