Historical
ONORM EN ISO 11607-1:2020
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
This document lays down requirements and test procedures for materials, prefabricated sterile barrier systems, sterile barrier systems and packaging systems designed to maintain the sterility of medical devices sterilized in final packaging by the time of use. It applies to industry, healthcare facilities and all other facilities where medical devices are packaged and sterilised in sterile barrier systems. It does not cover all requirements for sterile barrier systems and packaging systems for aseptically manufactured medical devices. Combinations of medicines and medical devices may require additional requirements. It does not describe a quality assurance system for steering all manufacturing steps. It does not apply to packaging materials and/or systems used to recover a contaminated medical device during transport for reprocessing or disposal ...
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Austrian Standards Institute [on]