DIN Standards Committee Optics and Precision Mechanics
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
Abstract
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.
Begin
2022-03-29
WI
00206093
Planned document number
DIN EN ISO 10993-7 rev
Project number
02703364
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
Responsible international committee
ISO/TC 194/WG 11 - Allowable limits for leachable substances