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Implants for surgery—Calcium phosphates—Part 3:Hydroxyapatite and beta-tricalcium phosphate bone substitutes
Standard in brief
Scope of Application:
YY/T 1558的本部分规定了单相羟基磷灰石、单相β磷酸三钙和双相羟基磷灰石/β磷酸三钙块状和颗粒骨替代物的要求。
本部分不适用于含细胞骨填充物、磷酸钙骨水泥或不含羟基磷灰石和β磷酸三钙的其他骨填充材料。
Basic information
Standard No:YY/T 1558.3-2017
Standard Name:外科植入物 磷酸钙 第3部分:羟基磷灰石和β-磷酸三钙骨替代物
English Name:Implants for surgery—Calcium phosphates—Part 3:Hydroxyapatite and beta-tricalcium phosphate bone substitutes
Standard Status:现行
Release Date:2017-09-25
Effective Date:2018-10-01
Language of Publication:中文简体
Standard Classification
ICS Number:11.040.40
CCS Number:C35
Related Standards
Referenced Standards:ISO 2591-1,ISO 10993-1,ISO 13320,ISO 13383-1,ISO 13779-3,ISO 15901-1,ISO 80000-1
Adopted Standards:ISO 13175-3:2012
Adopted Standard Name:《外科植入物 磷酸钙 第3部分:羟基磷灰石和 β-磷酸三钙骨替代物》
Adoption Level:IDT
Publication Information
Number of pages:16
Number of words:24 K
Format:大16
Edition:1
Color Pages:0
Electronic Version:Yes
Color Images:No
Print Publication Date:2017-11-01
Standard Revision Information
Has Amendment:No
Other Information
Application Dept:国家食品药品监督管理总局
Standard Type:QT
Standard Attribute:YY
Other Standard Number:1558.3
Drafter:卢建熙、卢霄、姚宸维、林开利、马春宝、姜熙、王迎军、任力
Drafting Organization:天津市医疗器械质量监督检验中心、上海贝奥路生物材料有限公司、华南理工大学材料科学与工程学院
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:国家食品药品监督管理总局