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Chinese Standard: GB/T 23101.3-2023

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Implants for surgery—Hydroxyapatite—Part 3:Chemical analysis and characterization of crystallinity ratio and phase purity


Standard in brief
Scope of Application:  
本文件描述了羟基磷灰石材料,包括粉末、涂层或陶瓷的化学分析、结晶度和相组成评估的测定方法。

Basic information
Standard No:GB/T 23101.3-2023
Standard Name:外科植入物 羟基磷灰石 第3部分:结晶度和相纯度的化学分析和表征
English Name:Implants for surgery—Hydroxyapatite—Part 3:Chemical analysis and characterization of crystallinity ratio and phase purity
Standard Status:现行
Release Date:2010-09-02
Effective Date:2024-12-01
Language of Publication:中文简体

Standard Classification
ICS Number:11.040.40
CCS Number:C35

Related Standards
Referenced Standards:GB/T 6003.1,GB/T 6682
Adopted Standards:ISO 13779-3:2018
Adopted Standard Name:《外科植入物 羟基磷灰石 第3部分:结晶度和相纯度的化学分析和表征》
Adoption Level:MOD

Publication Information
Number of pages:32
Number of words:58 K
Format:大16
Edition:1
Color Pages:0
Electronic Version:Yes
Color Images:No
Print Publication Date:2023-11-01

Standard Revision Information
Has Amendment:No

Other Information
Application Dept:国家市场监督管理总局、国家标准化管理委员会
Standard Type:CN
Standard Attribute:GB
Other Standard Number:23101.3
Drafter:袁暾、马春宝、李亚东、曾达、邓翔、张海明、俞天白、王书明、魏淼、邹文、朱进清、李亚军、陈艳文、李家林、张松伟、温敏、王梦圆、赵婷婷
Drafting Organization:四川大学、天津市医疗器械质量监督检验中心、苏州鼎安科技有限公司、大博医疗科技股份有限公司、四川医疗器械生物材料和制品检验中心有限公司、史赛克(北京)医疗器械有限公司、苏州微创关节医疗科技有限公司、国标(北京)检验认证有限公司、麟科泰医疗技术(无锡)有限公司
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

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