BAS EN ISO 10993-7:2009
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
General Information
Status: Published
No. of pages: 91
Language: English
Edition: 2.
Adoption method: Endorsment
Publication date: 24.12.2009
Technical committee:
Directive:
90/385/EEC, Active implantable medical devices
93/42/EEC, Medical devices;
93/42/EEC, Medical devices;
...
Abstract
ISO 10993-7:2008 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 the standard is applied are also included in informative annexes.
EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by ISO 10993-7:2008.
Lifecycle
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Original document and degree of correspondence
- EN ISO 10993-7:2008, identical
- ISO 10993-7:2008, identical