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Test method for molecular weight averages and molecular weight distribution of polylactic acid and its copolymers for surgical implants
Standard in brief
Scope of Application：
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。
Basic information
Standard No：YY/T 1678-2019
Standard 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
English Name：Test method for molecular weight averages and molecular weight distribution of polylactic acid and its copolymers for surgical implants
Standard Status：现行
Release Date：2019-10-23
Effective Date：2020-10-01
Language of Publication：中文简体
Standard Classification
ICS Number：11.040.30
CCS Number：C30
Related Standards
Referenced Standards：GB/T 2035-2008
Publication Information
Number of pages：12
Number of words：16 K
Format：大16
Edition：1
Color Pages：0
Electronic Version：Yes
Color Images：No
Print Publication Date：2019-11-01
Standard Revision Information
Has Amendment：No
Other Information
Application Dept：国家药品监督管理局
Standard Type：QT
Standard Attribute：YY
Other Standard Number：1678
Drafter：黄元礼、柯林楠、刘丽、汤京龙、王春仁
Drafting Organization：中国食品药品检定研究院
Management Organization：全国外科植入物和矫形器械标准化技术委员会(SAC/TC 110)
Proposing Department：国家药品监督管理局
