CAN/CSA-ISO 10993.7-98 (R2002):1998 Edition

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Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals

Published By	Publication Date	Number of Pages
CSA	1998	54

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Categories: 11.100.20 - Biological evaluation of medical devices, CSA

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Description

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.

Additional information

Published Code	CSA
Published By	Canadian Standards Association
Publication Date	1998
Pages Count	54
Language	France
Descriptors	Medical Equipment, Ethylene Oxide, Sterilization, Tests, Biological Tests, Bioassay, Determination, Chemical Residues.
File Size	2.7 MB
ICS Codes	11.100.20 - Biological evaluation of medical devices