[Research on Chemical Equivalence Characteristics of Polylactic Acid in Medical Devices]

Jing Qin; Yahong Kang; Yong Shen; Xin Song; Hongyu Luo; Hongyan Jiang

doi:10.3969/j.issn.1671-7104.2018.04.004

[Research on Chemical Equivalence Characteristics of Polylactic Acid in Medical Devices]

Zhongguo Yi Liao Qi Xie Za Zhi. 2018 Jul 30;42(4):246-249. doi: 10.3969/j.issn.1671-7104.2018.04.004.

[Article in Chinese]

Authors

Jing Qin¹, Yahong Kang¹, Yong Shen², Xin Song¹, Hongyu Luo², Hongyan Jiang¹

Affiliations

¹ Shanghai MicroPort Medical(Group) Co. Ltd., Shanghai, 201203.
² Shandong Quality Inspection Center for Medical Devices, Jinan, 250000.

PMID: 30112885
DOI: 10.3969/j.issn.1671-7104.2018.04.004

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.

Keywords: Polylactic acid(PLA); chemical characterization; chemical equivalence.

MeSH terms

Equipment and Supplies*
Lactic Acid
Polyesters / chemistry*
Polymers

Substances

Polyesters
Polymers
Lactic Acid
poly(lactide)