GB 12264-1990
Replaced
YY 0017-2026
Pending
Industry standards-Medicine
YY 0017-2026 Implants for osteosynthesis—Metallic bone plates
YY 0017-2026 Implants for osteosynthesis—Metallic bone plates
Basic Information
Standard Code:
YY 0017-2026
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:
2026-03-09
Implement Date:
2028-03-01
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骨科植入物分技术委员会(SAC/TC 110/SC 1)
Pages:
20 pages
Scope
本文件规定了骨接合植入器械金属接骨板(以下简称“接骨板”)的要求、制造、灭菌、包装及制造商提供的信息,描述了相应的试验方法。
本文件适用于骨科手术中连接和固定骨折断端的接骨板。
本文件不适用于金属脊柱板、颅颌面接骨板和可吸收金属接骨板。
注:可吸收金属接骨板可参考本文件,附录A给出了相关信息。
Development Information
Replace the following standards
Referenced Standards
GB/T 4340.1-1999 Metallic materials—Vickers hardness test—Part 1:Test method
GB/T 4340.1-2009 Metallic materials—Vickers hardness test—Part 1:Test method
GB/T 4340.1-2024 Metallic materials—Vickers hardness test—Part 1:Test method
GB/T 10610-1998 Geometrical product Specifications(GPS)—Surface texture:Profile method—Rules and procedures for the assessment of surface texture
GB/T 10610-2009 Geometrical Product Specifications(GPS)—Surface texture:Profile method—Rules and procedures for the assessment of surface texture
GB/T 14233.3-2024 Test methods for infusion,transfusion,injection equipments for medical use—Part 3:Microbiological test methods
GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals
GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals
YY 0341.1-2020 Non-active surgical implants—Osteosynthesis and spinal implants—Part 1:Particular requirements for osteosynthesis implants
YY/T 0342-2002 Implants for surgery—Determination of bending strength and stiffness of bone plates
YY/T 0342-2020 Implants for surgery—Determination of bending strength and stiffness of bone plates
YY/T 0343-2002 Liquid penetrant inspection of metallic surgical implants
YY/T 0640-2016 Non-active surgical implants—General requirements
YY/T 0856-2011 Implants for orthosynthesis—Metallic angled fixation device
YY/T 1074-2002 Implants for surgery—Measuring method for pitting corrosion potential on stainless products
YY/T 1503-2016 Implants for surgery—Test method for determining the bending fatigue properties of metallic bone plates
YY/T 1615-2018 Surgical implants—Anodizing oxide layers on titanium and titanium alloys—General requirements
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