EVS-EN ISO 11607-1:2020/A1:2023

ISO 11607-1 describes requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems. EN ISO 11607-1:2020/A1:2023 modifies the European standard EN ISO 11607-1:2020. The main text of this standard can be found in the standard’s history.

In this amendment you can find:

— the relationship between EN ISO 11607-1 and the General Safety and Performance Requirements of Regulation (EU) 2017/745,

— the relationship between EN ISO 11607-1 and the General Safety and Performance Requirements of Regulation (EU) 2017/746,

— Annex F (normative) which covers risk management topics,

— Annex G (informative) which covers risk management for medical device packaging and gives rationale for the requirements.