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

Standard No.

EN ISO 10993-7:2008

Release Date

2008

Published By

European Committee for Standardization (CEN)

Status

Be replaced

Replace By

EN ISO 10993-7:2008/AC:2009

Latest

EN ISO 10993-7:2008/A1:2022

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, andmethods for determining compliance so that devices may be released. Additional background, includingguidance and a flowchart showing howThis document is applied, are also included in the informative annexes.

EN ISO 10993-7:2008 history

• 2022 EN ISO 10993-7:2008/A1:2022 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)
• 2009 EN ISO 10993-7:2008/AC:2009 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009)
• 2008 EN ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
• 1995 EN ISO 10993-7:1995 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals (ISO 10993-7 : 1995)