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Implants for surgery—Standard test method for dissolution testing of calcium phosphate granules,fabricated forms and coatings
Standard in brief
Scope of Application:
本标准规定了评价磷酸钙材料溶解速率的试验方法。
本标准适用于外科植入物用磷酸钙材料,包括符合GB 23101.1、GB 23101.2的羟基磷灰石,符合YY/T 0683规定的β磷酸三钙和无添加或添加了其他次要成分(<10%)的双相复合物等。
Basic information
Standard No:YY/T 1640-2018
Standard Name:外科植入物 磷酸钙颗粒、制品和涂层溶解性的试验方法
English Name:Implants for surgery—Standard test method for dissolution testing of calcium phosphate granules,fabricated forms and coatings
Standard Status:现行
Release Date:2018-12-20
Effective Date:2020-01-01
Language of Publication:中文简体
Standard Classification
ICS Number:11.040.40
CCS Number:C35
Related Standards
Referenced Standards:GB 23101.1,GB 23101.2,YY/T 0683-2008
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:2019-01-01
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:1640
Drafter:马春宝、李沅、李佳、姜熙
Drafting Organization:天津市医疗器械质量监督检验中心
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