45.99 Dispatch of FV draft to CCMC Dec 6, 2024
CEN
CEN/TC 206 Biological and clinical evaluation of medical devices
European Norm
11.100.20 Biological evaluation of medical devices
ISO 10993-7:2008 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 the standard is applied are also included in informative annexes.
EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by ISO 10993-7:2008.
Legislation related to this standard
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
PUBLISHED
EN ISO 10993-7:2008/AC:2009
PUBLISHED
EN ISO 10993-7:2008/A1:2022
PUBLISHED
EN ISO 10993-7:2008
IN_DEVELOPMENT
prEN ISO 10993-7
45.99
Dispatch of FV draft to CCMC
Dec 6, 2024