SS 647:2019
Standard guide for accelerated aging of sterile barrier systems for medical devices
OVERVIEW
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 defined in ANSI/AAMI/ISO 11607–1:2006 and the physical properties of their component packaging materials.
Addresses the sterile barrier systems in whole with or without devices. The sterile barrier system material and device interaction compatibility that may be required for new product development or the resulting evaluation is not addressed in this guide.
Does not address real-time aging protocols; however, it is essential that real-time aging studies be performed to confirm the accelerated aging test results using the same methods of evaluation.
Does not cover methods used for sterile barrier system validation, which include the machine process, the effects of the sterilisation process, environmental challenge, distribution, handling, and shipping events.
Also does not address environmental challenging that stimulates extreme climactic conditions that may exist in the shipping and handling environment.
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2019 |
| No. of Pages | 18 |
| ICS Classification | 11.080.30 Sterilized packaging |
| Committee | Biomedical and Health Standards Committee |
| Available for Purchase | For sale in Singapore only |
| Adoption | ASTM F1980-16 : 2016 IDT |