Research on Chemical Equivalence Characteristics of Polylactic Acid in Medical Devices.
10.3969/j.issn.1671-7104.2018.04.004
- Author:
Jing QIN
1
;
Yahong KANG
1
;
Yong SHEN
2
;
Xin SONG
1
;
Hongyu LUO
2
;
Hongyan JIANG
1
Author Information
1. Shanghai MicroPort Medical(Group) Co. Ltd., Shanghai, 201203.
2. Shandong Quality Inspection Center for Medical Devices, Jinan, 250000.
- Publication Type:Journal Article
- Keywords:
Polylactic acid(PLA);
chemical characterization;
chemical equivalence
- MeSH:
Equipment and Supplies;
Lactic Acid;
Polyesters;
chemistry;
Polymers
- From:
Chinese Journal of Medical Instrumentation
2018;42(4):246-249
- CountryChina
- Language:Chinese
-
Abstract:
Polylactic acid is synthesized indirectly by the polymerization method, according to the standard GB/T 16886.18-2011, the evaluation parameters and methods about chemical characterization of polylactic acid have been established. By using rigorous and comprehensive comparative analysis, the chemical equivalency of domestic and imported polylactic acid materials has been proved, along with the "Medical Device Biology Evaluation and Review Guide", paving the way of using domestic polylactic acid in implantable medical devices.
