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CAN/CSA-ISO 10993.7-98 (R2009)
Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals (Adopted ISO 10993-7:1995)
SKU: 2410864
Publié par CSA Group
Année de publication 1998
Confirmé(e) en 2009
54 pages
Withdrawn
détails du produit
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.
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.