Historical
ONORM EN ISO 11607-2:2018
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006, including Amd 1:2014)
This part of ISO 11607 describes the requirements for the development and validation of processes for packaging medical devices are sterilized in the final package. These processes include forming, sealing, and assembling prefabricated sterile barrier systems, sterile barrier systems and packaging systems. This part of ISO 11607 applies to the industry for health care facilities and all other facilities where medical devices are packaged and sterilized. This part of ISO 11607 covers not all requirements for packaging of aseptically manufactured medical products. For combinations of medicinal products and medical devices, additional requirements may be necessary.
Content Provider
Austrian Standards Institute [on]
