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Standard

NS-EN ISO 11737-2:2000

Tilbaketrukket

Merknad: Denne standarden har en ny utgave: NS-EN ISO 11737-2:2020

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Omfang

1.1 This part of ISO 11737 specifies the general criteria for tests of sterility on medical devices which have been exposed to a treatment with the sterilizing agent that is a fraction of the specified sterilization process. These tests are intended to be performed when validating a sterilization process. 1.2 This part of ISO 11737 is not applicable to: a) sterility testing for routine release of product that has been subjected to a sterilization process; b) performance of a pharmacopoeial test for sterility; or NOTE 1 The performance of a) or b) above is not a requirement of ISO 11134, 11135 or 11137. c) culturing of biological indicators, including inoculated products. NOTE 2 Methods of culturing biological indicators are described in ISO 11138.

Dokumentinformasjon

  • Standard fra SN
  • Publisert:
  • Tilbaketrukket:
  • Utgave: 1
  • Versjon: 1
  • Varetype: NAT
  • Products.Specs.pages
  • ICS 07.100.10
  • ICS 11.080
  • ICS 11.080.01
  • National Committee CEN/TC 204

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