EN
SR EN ISO 10993-7:2009
Evaluarea biologică a dispozitivelor medicale. Partea 7: Reziduuri de sterilizare cu oxid de etilenă
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.
Status :
In vigoare
Data aprobării : 31.03.2009
Data publicării : 02.04.2009
Număr de pagini : 98
ICS : 11.100.20 Evaluarea biologica a dispozitivelor medicale
Comitet tehnic : 377 - Medicale
- Inlocuieste SR EN ISO 10993-7:2003
- Modificat de SR EN ISO 10993-7:2009/AC:2010
- Modificat de SR EN ISO 10993-7:2009/A1:2022