Скачать или смотреть Key Definitions and Terminology in ISO 11607

ISO 11607 introduces several key definitions and terminology critical for understanding the requirements for packaging terminally sterilized medical devices. "Sterile Barrier System (SBS)" refers to the minimum packaging configuration that prevents the ingress of microorganisms and allows aseptic presentation of the product at the point of use. "Packaging System" encompasses the sterile barrier system and additional packaging configurations necessary to protect the sterile barrier system and its contents. "Terminal Sterilization" is the process of sterilizing the device within its final packaging. "Validation" in this context involves demonstrating that the packaging processes—such as forming, sealing, and assembly—consistently produce a package that meets the predefined criteria. Another important term is "Shelf Life," which refers to the period during which a sterile medical device is expected to remain sterile under specified storage conditions. These terms and definitions form the foundation for implementing the packaging requirements in ISO 11607, ensuring that medical devices are safely and effectively delivered to the point of use​.

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Timecodes
0:00 - Introduction
0:34 - Sterile Barrier System (SBS)
0:54 - Preformed Sterile Barrier System
1:13 - Packaging System
1:32 - Terminal Sterilization
1:48 - Aseptic Presentation
2:07 - Sterilization Compatibility
2:23 - Microbial Barrier
2:40 - Integrity Testing
2:53 - Accelerated Aging
3:14 - Sealing
3:28 - Relevance of These Terms
4:06 - Conclusion