Historical
ONORM EN ISO 11607-2:2020
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
This document lays down 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, sterile barrier systems and packaging systems. It applies to industry, healthcare facilities and all other facilities where medical devices are packaged and sterilised. It does not cover all requirements for packaging of aseptically manufactured medical devices. Combinations of medicines and medical devices may require additional requirements.
Content Provider
Austrian Standards Institute [on]
