Standard

NS-EN ISO 10993-7:2008

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Abstract

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.

Document information

  • Standard from SN
  • Published:
  • Edition: 2008-10
  • Version: 1
  • Document type: NAT
  • ICS 11.100.20
  • National Committee SN/K 115

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

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