DIN Standards Committee Optics and Precision Mechanics
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
Abstract
This document specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in 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 or components that have neither direct nor indirect patient contact (e.g., in vitro diagnostic devices) are out of scope of this document. This document does not apply to devices that have been demonstrated to not absorb or retain EO or its degradation product ECH, such as medical devices made exclusively of metal alloys and glass, see Annex C.5. NOTE This document does not specify limits for ethylene glycol (EG). No device limits are specified for EG because the risk assessment in Annex F indicates that calculated allowable levels are higher than those likely to occur in a medical device.
Begin
2022-03-29
WI
00206093
Planned document number
DIN EN ISO 10993-7
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
