ISO 10993-7:1995
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

Standard No.

ISO 10993-7:1995

Release Date

1995

Published By

International Organization for Standardization (ISO)

Status

Withdraw

Replace By

ISO 10993-7:2008

Latest

ISO 10993-7:2008/Amd 1:2019

Scope

Specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices and procedures for the measurement of EO and ECH. Does not apply for EO-sterilized devices that have no patient contact such as in vitro diagnostic devices.

ISO 10993-7:1995 history

• 2019 ISO 10993-7:2008/Amd 1:2019 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infants
• 2009 ISO 10993-7:2008/cor 1:2009 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1
• 2008 ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
• 1995 ISO 10993-7:1995 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals