Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants
Abstract
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
Begin
2024-01-02
WI
00206107
Planned document number
DIN EN ISO 10993-7/A11
Project number
02703425
Responsible national committee
NA 027-07-12 AA - Biological evaluation of medical devices
Responsible european committee
CEN/TC 206 - Biological and clinical evaluation of medical devices
