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Standard

ISO 10993-7:2008

Publisert

Obs: Denne standarden har et forslag: ISO/FDIS 10993-7

Forhåndsvisning

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Omfang

ISO 10993-7:2008 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released. Additional background, including guidance and a flowchart showing how the standard is applied are also included in informative annexes. EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by ISO 10993-7:2008.

Dokumentinformasjon

  • Standard fra ISO
  • Publisert:
  • Utgave: 2
  • Versjon: 1
  • Varetype: IS
  • Products.Specs.pages
  • ICS 11.100.20
  • ISO TC ISO/TC 194

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