New Guide for Standard Guide for Real Time Aging of Sterile Barrier Systems and Medical Devices
1. Scope
This guide provides information for developing real time aging protocols to confirm the effects of the passage of time on the sterile integrity of the sterile barrier system (SBS), as defined in ANSI/AAMI/ISO 11607–1: 2019 and the physical properties of their component packaging materials.
Keywords
material stability; degredation
Rationale
No standard currently exists for real time aging protocols. This leads to variation in the approaches used for real time aging of medical devices and associated packaging.