EN
SR EN ISO 11607-1:2020
Ambalaje pentru dispozitive medicale sterilizate în etapa finală. Partea 1: Cerințe pentru materiale, sisteme de bariere sterilă și sisteme de ambalare
This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use. It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized. It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations. It does not describe a quality assurance system for control of all stages of manufacture. It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.
Status :
In vigoare
Data aprobării : 30.04.2020
Număr de pagini : 56
ICS : 11.080.30 Ambalaje sterile
Comitet tehnic : 377 - Medicale
- Inlocuieste SR EN ISO 11607-1:2017
- Modificat de SR EN ISO 11607-1:2020/A11:2022
- Modificat de SR EN ISO 11607-1:2020/A1:2023