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)
This standard specifies the requirements and tests for evaluating residual ethylene oxide in medical devices. It is part of a series that assesses biological evaluation aspects of medical devices, with this particular part focusing on the assessment of ethylene oxide residuals following sterilization processes. The document provides guidance on selecting appropriate test methods and interpreting results to ensure patient safety.
*** Please note: This description may not be accurate, please refer to the official documentation.
EN ISO 10993-7:2008/A1:2022 history
2022EN 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)
2009EN 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)
2008EN ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
1995EN ISO 10993-7:1995 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals (ISO 10993-7 : 1995)