EVS-EN ISO 11607-2:2020

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 transport conditions. It is also important that medical devices delivered in a sterile state are manufactured, packed and sterilized by validated methods.

Regulatory authorities recognize the critical nature of sterile barrier systems by considering them as an accessory or a component of a medical device. In many parts of the world preformed sterile barrier systems are considered medical devices. ISO 11607-2 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug or device combinations.

The international standard has been approved in Europe as EN ISO 11607-2:2020 without any changes and it supersedes EN ISO 11607-2:2017.