Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices Ingestion-build-48068 Assessment checklist

Assessment checklist

infrared radiation is usually generated by infrared emitters and infrared radiation is significantly dominating overheat convection or heat

Under the conditions specified in this International Standard

because the same tolerances are applicable to the O-rings in this part of ISO 16031

Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices Ingestion-build-48068 Assessment checklist1. 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.