Standard

NS-EN ISO 10993-7:2008

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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 SN
  • Publisert:
  • Utgave: 2008-10
  • Versjon: 1
  • Varetype: NAT
  • ICS 11.100.20
  • National Committee SN/K 115

Referanser i lov

EU lov: 93/42/EEC, 90/385/EEC

Produktrelasjon

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