SS-EN-ISO-10993-7 › Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

SS-EN-ISO-10993-7 - 2008 EDITION - CURRENT
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Included in this current edition are the following subparts:

 2008 EDITION - Oct. 20, 2008
 2008/AC:2009 EDITION CORRIGENDUM - Nov. 23, 2009
 FOR 2008 EDITION AMENDMENT 1 SEE - Jan. 19, 2022

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, including guidance and a flowchart showing how this document is applied, are also included in the informative annexes. EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by this part of ISO 10993. NOTE This part of ISO 10993 does not specify limits for ethylene glycol (EG).

To find similar documents by classification:

11.020 (Medical sciences and health care facilities in general Including quality and environmental management in health care technology IT application in health care technology, see 35.240.80)

11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)


Active implantable medical devices. Medical devices

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Designation Name

SS-EN ISO 10993-7:2008

Revision Level

2008 EDITION

Status

Current

Publication Date

Oct. 20, 2008

Language(s)

English

Page Count

104

International Equivalent

EN ISO 10993-7:2008(IDT); ISO 10993-7:2008(IDT)