EN
SR EN ISO 11607-2:2020
Ambalaje pentru dispozitive medicale sterilizate în etapa finală. Partea 2: Cerințe de validare pentru procesele de formare, etanșare și asamblare
This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized. It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
Status :
In vigoare
Data aprobării : 30.04.2020
Număr de pagini : 24
ICS : 11.080.30 Ambalaje sterile
Comitet tehnic : 377 - Medicale
- Inlocuieste SR EN ISO 11607-2:2017
- Modificat de SR EN ISO 11607-2:2020/A11:2022
- Modificat de SR EN ISO 11607-2:2020/A1:2023