EVS-EN ISO 11607-1:2020+A11+A1:2023

ISO 11607-1 describes requirements and test methods for materials, preformed sterile and sterile barrier systems, and packaging systems. This standard can be used by anyone in the healthcare industry or healthcare facilities.

The process of designing and developing a packaging system for terminally sterilized medical devices is a complicated and critical endeavour. The device components and the packaging system should be combined to create a sterile medical device that performs efficiently, safely and effectively in the hands of the user. This text also includes an amendment A1 and A11.

The main text and the amendment can be found separately from the standard’s history.

The international standard has been approved in Europe as EN ISO 11607-1:2020 without any changes and it supersedes EN ISO 11607-1:2017.