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Implants for surgery—Forgings,castings for bone joint prostheses—Part 3:Cobalt chromium molybdenum alloy castings
Standard in brief
Scope of Application:
本文件规定了外科植入物用钴铬钼合金材料制造外科植入物骨关节假体铸件的要求、试验方法、 检验规则、质量证明、标记、包装、运输和贮存。
本文件适用于骨关节假体钴铬钼金铸件的生产和验收。
Basic information
Standard No:YY 0117.3-2024
Standard Name:外科植入物 骨关节假体锻、铸件 第3部分:钴铬钼合金铸件
English Name:Implants for surgery—Forgings,castings for bone joint prostheses—Part 3:Cobalt chromium molybdenum alloy castings
Standard Status:即将实施
Release Date:1993-01-01
Effective Date:2027-07-20
Language of Publication:中文简体
Standard Classification
ICS Number:11.040.40
CCS Number:C35
Related Standards
Referenced Standards:GB/T 223(所有部分),GB/T 228.1,GB/T 10610,HB 6573,HB 20160,YY/T 0343,YY/T 1565-2017
Publication Information
Number of pages:12
Number of words:19 K
Format:大16
Edition:1
Color Pages:0
Electronic Version:Yes
Color Images:No
Print Publication Date:2024-07-01
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:0117.3
Drafter:熊震国、覃格姬、李庆春、李沅、张娜、张家振、孙嘉怿、李铮、卢敏琪、李妮娅、曾达、梁雄伟、谢永志、钟林招
Drafting Organization:北京优材京航生物科技有限公司、天津市医疗器械质量监督检验中心、国家药品监督管理局医疗器械技术审评中心、国家药品监督管理局医疗器械技术审评检查大湾区分中心、大博医疗科技股份有限公司、北京昌航精铸技术有限公司
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