Standard

ISO 11137-2:2013

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Merknad: Denne standarden har en ny utgave: ISO 11137-2:2013

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ISO 11137-2:2013 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.

Dokumentinformasjon

  • Standard fra ISO
  • Publisert:
  • Utgave: 3
  • Versjon: 1
  • Varetype: IS
  • Products.Specs.pages
  • ICS 11.080.01
  • ISO TC ISO/TC 198

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