CNS 14393-13-2005
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (English Version)
- Standard No.
- CNS 14393-13-2005
- Language
- Chinese, Available in English version
- Release Date
- 2005
- Published By
- Taiwan Provincial Standard of the People's Republic of China
- Latest
- CNS 14393-13-2005
- Scope
- This standard provides general guidelines that must be followed when designing qualitative and quantitative tests for the degradation products of polymer medical devices used clinically. And standardize two ways to generate degradation products: one is the accelerated degradation test as a screening method, and the other is the real-time degradation test. For in-situ polymerized materials, the cured or hardened polymer is used for testing. The data generated is used to aggregate
CNS 14393-13-2005 history
- 2005 CNS 14393-13-2005 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
