YY/T 0473-2004 Active
YY/T 0473-2004 Implants for surgery—Copolymers and blends based on polylactide—In vitro degradation testing
Abstract
This standard applies to blocks or processed materials of poly(lactide-co-glycolide) copolymers and/or blends used in the production of surgical implants. This standard describes the determination of changes in the chemical and/or mechanical properties of these copolymers and/or blends under in vitro degradation conditions. The test methods specified in this standard are used to determine the degradation rate and changes in material properties of poly(lactide-co-glycolide) copolymers and/or blends containing different comonomers (such as glycolide, trimethylene carbonate, and ε-caprolactone) in vitro. These in vitro test methods cannot be used to accurately predict the behavior of materials under in vivo conditions. The purpose of this standard is to compare and/or evaluate materials or processing conditions.
General Product Information
| Document Type | Industry standards-Medicine |
|---|---|
| Standard Status | Active |
| Standard Code | YY/T 0473-2004 |
| CCS | Medical devices |
| ICS | Surgical implants, prostheses, and orthoses |
| Implement Date | 2005-01-01 |