Norm

NEN-EN 552:1995 en

Sterilisatie van medische hulpmiddelen - Validatie en routinecontrole van sterilisatie door bestraling

  • Deze norm is ingetrokken sinds 15-05-2006

49,30

Over deze norm

Status Ingetrokken
Aantal pagina's 21
Gepubliceerd op 01-05-1995
Taal Engels
This standard specifies requirements for the validation, process control and monitoring of the radiation sterilization of medical devices. It is applicable to continuous and batch type gamma irradiators using the radionuclides 60Co or 137Cs and to irradiators using electrons generated from machine sources operated at or below and energy level of 10 MeV. This standard specifies the requirements which ensure that a predetermined dose is consistently absorbed by product presented to the sterilization process. The manufacture of the product has responsibility for the quality of the product including the selection of dose and the attainment of the required sterility assurance level (SAL). The operator of the radiation sterilizaion facility has responsibility for delivering the stipulated absorbed dose. This standard does not cover the assessment of the suitability of a product for its intended use after radiation sterilization; neither does it cover operator safety.

Details

ICS-code 11.080.01
Nederlandse titel Sterilisatie van medische hulpmiddelen - Validatie en routinecontrole van sterilisatie door bestraling
Engelse titel Sterilization of medical devices - Validation and routine control of sterilization by irradiation
Vervangen door
Gewijzigd door
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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