SS 647:2025
Standard guide for accelerated aging of sterile barrier systems and medical devices
OVERVIEW
This standard provides information for developing accelerated aging protocols to model the possible effects of the passage of time on the sterile integrity of the sterile barrier system (SBS), as defined in SS ISO 11607-1:2019 and the physical properties of their component packaging materials. Guidance for developing accelerated aging protocols may also be used for medical devices and medical device materials.
Real-time aging protocols are not addressed in this standard; however, it is essential that real-time aging studies be performed to confirm the accelerated aging test results using the same methods of evaluation.
Methods used for sterile barrier system performance validation, which include, environmental challenge, distribution, handling, and shipping events, are used for package performance (event-related loss of integrity) testing and are beyond the scope of this standard.
This standard does not address environmental challenging that simulates extreme climactic conditions that may exist in the shipping and handling environment.
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2025 |
| No. of Pages | 11 |
| ICS Classification | 11.080.30 Sterilized packaging |
| Committee | Biomedical and Health Standards Committee |
| Available for Purchase | For sale in Singapore only |
| Adoption | ASTM F1980 : 2021 IDT |