EVS-EN ISO 11607-2:2020+A11:2022

EN ISO 11607-2 sets out requirements for the development and validation of processes for packaging medical devices that are terminally sterilized.

The standard can be used in medical industry, health care facilities or wherever medical devices are packaged and sterilized.

EN ISO 11607-2 helps to ensure that the medical device can be sterilized and remain sterile in storage or in transport conditions. It is also important that medical devices delivered in a sterile state are manufactured, packed and sterilized by validated methods.

In this consolidated version you can also find:

— relationship between the standard and the requirements of Directive 93/42/EEC,

— relationship between the standard and the requirements of Directive 90/385/EEC,

— relationship between the standard and the requirements of Directive 98/79/EC,

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