CSA Group Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals ISO 10993-7:2008

Description
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.
  • Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - ISO 10993-7:2008 - CSA Group
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Description
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.

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Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - ISO 10993-7:2008 - CSA Group
CSA Group
Toronto, Ontario, Canada
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ISO 10993-7:2008
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals ISO 10993-7:2008
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.

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.

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Technical Specifications

  CSA Group
Product Category Standards and Technical Documents
Product Number ISO 10993-7:2008
Product Name Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
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