DIN EN ISO 11607-2:2024-02

This document provides the framework for activities and requirements for the development and validation of the processes used in the manufacture and assembly of the packaging system. This part of DIN EN ISO 11607 specifies requirements for the development and validation of packaging processes for medical devices that are sterilized in the final packaging. These processes include the forming, sealing and assembly of prefabricated sterile barrier systems and packaging systems. It applies to industry, healthcare facilities and all other facilities where medical devices are packaged and sterilized. It does not cover all packaging requirements for aseptically manufactured medical devices. Additional requirements may be necessary for combinations of drugs and medical devices. Amendment 1 extends the application of risk management to all phases of design, development, validation and production of the packaging system. The 2020 version is thus extended to include, among other things, Annex B "Risk Management". This standard has been prepared by Working Committee NA 176-03-07 AA "Sterilgutversorgung" ("Sterile Supply") at DIN Standards Committee Health Technologies (NAGesuTech).