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Standard

ISO/DIS 10993-7

Entwurf

Hinweis: Neuste Ausgabe: ISO 10993-7:2008

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Bestehende oder zukünftige Amendments und Versionen müssen separat erworben werden.

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Zusammenfassung

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.

Produktspezifikationen

  • Standard von ISO
  • Einspruchsfrist bis:
  • Edition: 3
  • Dokumenttyp: IS
  • Seiten
  • Herausgeber: ISO
  • Lieferant: ISO
  • ICS: 11.100.20
  • Internationales Komitee: ISO/TC 194

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