SS-EN-ISO-10993-7-AM1 › Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)

SS-EN-ISO-10993-7-AM1 - 2008 EDITION AMENDMENT 1 - CURRENT


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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).

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


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Designation Name

SS-EN ISO 10993-7:2008/A1:2022

Revision Level

2008 EDITION AMENDMENT 1

Status

Current

Publication Date

Jan. 19, 2022

Language(s)

English

Page Count

16

International Equivalent

EN ISO 10993-7:2008/A1:2022(IDT); ISO 10993-7:2008/Amd 1:2019(IDT)