CNS 14393-9-2005
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (English Version)
- Standard No.
- CNS 14393-9-2005
- Language
- Chinese, Available in English version
- Release Date
- 2005
- Published By
- Taiwan Provincial Standard of the People's Republic of China
- Latest
- CNS 14393-9-2005
- Scope
- This standard applies to general principles for the design and performance of medical devices and biodegradation studies that provide systematic evaluation of potential and observed biodegradation of medical devices. This standard does not apply to: (1) Living tissue engineering products; (2) Research methods that produce degradation products through mechanical procedures. The research methods used to generate such degradation products are described in the specific product standards; (3) Leachable components of non-degradation products
CNS 14393-9-2005 history
- 2005 CNS 14393-9-2005 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
