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Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices Ingestion-build-48068 Under the conditions specified in
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Description
Under the conditions specified in this International Standard
commonly used formulae with associated interpretations
This part of IEC 62271
because the same tolerances are applicable to the O-rings in this part of ISO 16031
The Graphical Kernel System for Three Dimensions (GKS-3D)
Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices Ingestion-build-48068 Under the conditions specified in1. Scope 1. 1 This guide provides information for developing accelerated aging protocols to rapidly determine the effects, if any, due to the passage of time on the sterile integrity of the sterile barrier system (SBS), as dened in ANSI AAMI ISO 116071: 2006 and the physical properties of their component packaging materials.
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