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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: 2700347
Published by CSA Group
Publication Year 1998
Reaffirmed in 2009
1 Edition
Withdrawn
Product Details
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.
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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)
Withdrawn
English
CAN/CSA-ISO 10993.7-F98 (C2009)
Évaluation biologique des dispositifs médicaux - Partie 7: Résidus de stérilisation à l'oxyde d'éthylène (norme ISO 10993- 7:1995 adoptée)
Withdrawn
French