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AAMI 10993-7

Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals

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Organization: AAMI
Publication Date: 1 January 2008
Status: active
Page Count: 18
scope:

This part of ISO 10993 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 this document is applied, are also included in the informative annexes.

EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by this part of ISO 10993.

NOTE This part of ISO 10993 does not specify limits for ethylene glycol (EG).

Document History

January 1, 2008
Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals
This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO...
AAMI 10993-7
January 1, 2008
Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals
This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO...
January 1, 2008
Biological evaluation of medical devices— Part 7: Ethylene oxide sterilization residuals
This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO...
December 1, 1995
Biological Evaluation of Medical Devices, Part 7: Ethylene Oxide Sterilization Residuals
A description is not available for this item.
December 1, 1995
Biological Evaluation of Medical Devices, Part 7: Ethylene Oxide Sterilization Residuals
A description is not available for this item.

References

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