Standards
Sterile barrier system
Also called: SBS
Sterile barrier system — The minimum package that keeps microorganisms out after sterilization and lets the device be opened aseptically at the point of use, as defined in ISO 11607.
Examples are a sealed paper-film pouch, a sealed length of sterilization reel, or a pack wrapped in sterilization paper. The material must let the sterilant in and out, then stay closed to microorganisms until opened.
ISO 11607-1 covers the materials and design; ISO 11607-2 covers validation of forming, sealing and assembly, such as the heat-sealing process for reels.
Related termsISO 11607EN 868-5Heat sealing
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