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ONORM EN ISO 11607-2:2022
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019) (consolidated version)
This document determines requirements for the development and validation of packaging processes for medical devices that are sterilized in the final packaging. These methods include shaping, sealing and compiling ready-made sterile barrier systems, sterile barrier systems and packaging systems. It applies to industry, health care facilities and for all other facilities in which medical devices are packed and sterilized. It does not cover all the requirements for packaging aseptically produced medical devices. Additional requirements may be required for combinations of medication and medical devices.
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Austrian Standards Institute [on]
