YY/T 0474-2004 Active
YY/T 0474-2004 Poly(L-lactide) resins and fabricated forms for surgical implants—In vitro degradation testing
Abstract
This standard describes the method for determining the changes in the chemical or mechanical properties of polylactic acid under in vitro degradation test conditions. The purpose of this standard is to compare and/or evaluate materials or processing conditions. This standard applies to various forms of polylactic acid used in the production of surgical implants, including: a) blocks; b) processed materials; c) final products (implants that have been packaged and sterilized). The test methods specified in this standard are used to determine the in vitro degradation rate of polylactic acid and the changes in material properties. However, these in vitro test methods cannot be used to accurately predict the behavior of the material under in vivo conditions.
General Product Information
| Document Type | Industry standards-Medicine |
|---|---|
| Standard Status | Active |
| Standard Code | YY/T 0474-2004 |
| CCS | Medical devices |
| ICS | Surgical implants, prostheses, and orthoses |
| Implement Date | 2005-01-01 |