SR EN 868-9:2019
Materiale de ambalare pentru dispozitive medicale sterilizate în stadiul terminal. Partea 9: Materiale nețesute de poliolefine, fără acoperire. Cerințe și metode de încercare
This document specifies test methods and values for uncoated nonwoven materials of polyolefines used for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. Other than the general requirements as specified in EN ISO 11607 1 and EN ISO 11607 2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this European Standard. The materials specified in this part of EN 868 are intended for single use only.
Status :
In vigoare
Data aprobării : 31.05.2019
Număr de pagini : 10
ICS : 11.080.30 Ambalaje sterile
Comitet tehnic : 377 - Medicale
- Inlocuieste SR EN 868-9:2009
EN