EVS-EN ISO 10993-7:2026

ISO 10993-7 specifies allowable limits (AL) for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in EO-sterilized medical devices. It also defines procedures for measuring EO and ECH, as well as methods for determining conformity prior to device release. Additional background, including guidance and a flowchart showing how this standard is applied, are also included in Annexes A, B, C, D, E, F, G, H, I, J and K.

EO-sterilized devices or components that have neither direct nor indirect body or user contact (e.g. in vitro diagnostic devices) are out of scope of this standard. ISO 10993-7 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.

ISO 10993-7:2026 text has been approved in Europe as EN ISO 10993-7:2026 without any changes.