ISO 11607
**ISO 11607**
What is ISO 11607?
ISO 11607 is an international standard for packaging for terminally sterilized medical devices. It addresses the requirements and test methods for packaging materials, sterile barrier systems, and packaging systems intended to maintain sterility of terminally sterilized medical devices until the point of use. It consists of two parts: ISO 11607-1 (Requirements for materials, sterile barrier systems and packaging systems) and ISO 11607-2 (Validation requirements for forming, sealing and assembly processes).
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