GB 12264-1990
Replaced
YY 0117.2-2024
Pending
Industry standards-Medicine
YY 0117.2-2024 Implants for surgery—Forgings,castings for bone joint prostheses—Part 2:ZTi6Al4V titanium alloy castings
YY 0117.2-2024 Implants for surgery—Forgings,castings for bone joint prostheses—Part 2:ZTi6Al4V titanium alloy castings
Basic Information
Standard Code:
YY 0117.2-2024
Standard Type:
Industry standards
Standard Status:
Pending
is_force_gb:
no
CCS Name:
Orthopaedic surgery, orthopaedic instruments
ICS Name:
Surgical implants, prostheses, and orthoses
Publish Date:
2024-07-08
Implement Date:
2027-07-20
Publisher:
国家药品监督管理局
Technical Committee:
全国外科植入物和矫形器械标准化技术委员会(SAC/TC 110)
Pages:
12 pages
Scope
本文件规定了由ZTi6Al4V钛合金材料制造的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ZTi6Al4V钛合金铸件的生产和验收。
Development Information
Drafting Units:
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、北京市春立正达医疗器械股份有限公司
Drafting Persons:
熊震国、覃格姬、刘大成、付瑞芝、朱进清、孙嘉怿、吴静、张译丹、李妮娅、卢敏琪、张春、解凤宝
Same series standard
Replace the following standards
Related Standards
GB 12279-1990
Replaced
GB 12279-1990 Cardiac valve prostheses general technical specification
GB 12417-1990
Replaced
GB 12417-1990 The general technological conditions of surgical metal implant
GB/T 13461-1992
Replaced
GB/T 13461-1992 Synthetic resin blow knee prostheses
GB/T 14191-1993
Replaced
GB/T 14191-1993 Terminology for prosthetics and orthotics
GB 14722-1993
Replaced