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ISO 10993-7

Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals; (CEN EN ISO 10993-7: 1995)

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Organization: ISO
Publication Date: 1 January 1995
Status: inactive
Page Count: 48
ICS Code (Laboratory medicine): 11.100
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 and guidance also is included in informative annexes.

EO-sterilized devices that have no patient contact (e.g. in vitro diagnostic devices) are not covered by this International Standard.

Document History

December 1, 2019
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals AMENDMENT 1: Applicability of allowable limits for neonates and infants
A description is not available for this item.
November 15, 2009
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals TECHNICAL CORRIGENDUM 1
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...
October 15, 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...
ISO 10993-7
January 1, 1995
Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals; (CEN EN ISO 10993-7: 1995)
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...

References

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