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ONORM EN ISO 11607-1:2022
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019) (consolidated version)
This document creates requirements and test methods for materials, prefabricated sterile barrier systems, sterile barrier systems and packaging systems that are intended to obtain the sterility of medical devices sterilized in the final packaging until the time of application. It applies to industry, health care facilities and for all other facilities in which medical devices are packed and sterilized in sterile barrier systems. It does not cover all requirements for sterile barrier systems and packaging systems for aseptically produced medical devices. Additional requirements may be required for combinations of medication and medical devices. It does not describe any quality assurance system for steering all manufacturing steps. It does not apply to packaging materials and/or/or systems that are used to absorb a contaminated medical device during transport for recovery or disposal.
Austrian Standards Institute [on]