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. This text also includes an amendment A1 and A11.