EN
SR EN ISO 10993-7:2026
Evaluarea biologică a dispozitivelor medicale. Partea 7: Reziduuri de sterilizare cu oxid de etilenă
This document specifies allowable limits (AL) 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 conformity so that devices can be released. Additional background, including guidance and a flowchart showing how this document 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 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 Clause C.5[228]. 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.
Status :
In vigoare
Data aprobării : 30.06.2026
Număr de pagini : 139
ICS : 11.100.20 Evaluarea biologica a dispozitivelor medicale
Comitet tehnic : 377 - Medicale
- Inlocuieste SR EN ISO 10993-7:2009
- Inlocuieste SR EN ISO 10993-7:2009/AC:2010
- Inlocuieste SR EN ISO 10993-7:2009/A1:2022