Standards
ISO 11607
Also called: ISO 11607-1, ISO 11607-2
ISO 11607 — International standard for packaging of terminally sterilized medical devices: Part 1 covers materials and systems, Part 2 covers validation of sealing and assembly.
ISO 11607-1 requires packaging materials to be compatible with the sterilization method, provide a microbial barrier, and keep the device sterile until use. ISO 11607-2 requires the packaging process — for example the heat sealer’s temperature, pressure and speed — to be validated and routinely checked.
For CSSDs this means using reels, pouches and wraps that declare conformity, and keeping records of sealer checks.
Related termsSterile barrier systemEN 868-5Heat sealing
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