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

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 the medical industry, health care facilities or wherever medical devices are packaged and sterilized.

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

In this consolidated version you can also find:

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

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

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