Standard No.:	YY/T 1678-2019
English Name:	Test methodfor molecular weight averages and molecular weight distribution of polylactic acid and its copolymers for surgical implants
Chinese Name:	外科植入物用聚乳酸及其共聚物分子量及分子量分布检测方法
Chinese Classification:	C30    Medical apparatus and devices in general
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.30 11.040.30    Surgical instruments and materials 11.040.30
Source Content Issued by:	National Medical Products Adminstration
Issued on:	2019-10-23
Implemented on:	2020-10-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	5500 words
Translation Price(USD):	165.0
Delivery:	via email in 1~3 business day

本标准规定了用高效体积排阻色谱法（HPSEC）测定可溶性聚乳酸平均分子量（Mw）和分子量分布的方法。本标准适用于外科植入物用，能被三氯甲烷（或其他溶剂）完全溶解的包括聚（L-乳酸）树脂（PLLA）、聚（D-乳酸）树脂（PDLA）、任何比率的DL型共聚体以及丙交酯（PLA）和丙交酯-乙交酯共聚物（PLGA）的材料。