EVS-EN ISO 11607-1:2020/A11:2022

ISO 11607-1 describes requirements and test methods for materials, preformed sterile and sterile barrier systems, and packaging systems. EN ISO 11607-1:2020/A11:2022 modifies the European standard EN ISO 11607-1:2020. The main text and the consolidated version which consists of the main text and the amendment can be found in the standard’s history.

In this amendment you can find:
— the relationship between EN ISO 11607-1and the essential requirements of Directive 93/42/EEC
— the relationship between EN ISO 11607-1 and the essential requirements of Directive 90/385/EEC
— the relationship between EN ISO 11607-1 and the essential requirements of Directive 98/79/EC