GB 12264-1990
Replaced
YY/T 0346-2022
Active
Industry standards-Medicine
YY/T 0346-2022 Implants for osteosynthesis—Metallic fixation screw for femur neck
YY/T 0346-2022 Implants for osteosynthesis—Metallic fixation screw for femur neck
Basic Information
Standard Code:
YY/T 0346-2022
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Orthopaedic surgery, orthopaedic instruments
ICS Name:
Surgical implants, prostheses, and orthoses
Publish Date:
2022-05-18
Implement Date:
2023-06-01
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委会(SAC/TC 110/SC 1)
Pages:
20 pages
Scope
本文件规定了金属股骨颈固定钉(以下简称股骨颈钉)的术语和定义、要求、试验方法、制造、灭菌、包装及制造商提供的信息。
本文件适用于股骨颈钉,该产品供骨科手术时作股骨颈骨折内固定用。
Development Information
Drafting Units:
天津市医疗器械质量监督检验中心、创生医疗器械(中国)有限公司、苏州微创脊柱创伤医疗科技有限公司、大博医疗科技股份有限公司、史赛克(北京)医疗器械有限公司、强生(上海)医疗器材有限公司
Drafting Persons:
景明、马春宝、张述、王涛、崔红、陈长胜、王剑、俞天白、李炫、曾达、张二来、张海明、张松伟、王戎斐、高相飞
Replace the following standards
Referenced Standards
GB 4234.1-2017 Implants for surgery—Metallic materials—Part 1:Wrought stainless steel
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 13810-1997 Wrought titanium and titanium alloy for surgical implants
GB/T 13810-2007 Wrought titanium and titanium alloy for surgical implants
GB/T 13810-2017 Wrought titanium and titanium alloy for surgical implants
GB/T 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity
GB/T 16886.5-2017 Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity
GB 23102-2008 Implants for surgery—Metallic materials—Wrought titanium-6aluminium-7niobium alloy
YY 0018-2002 Implants for osteosynthesis—Metallic bone screws
YY 0018-2008 Implants for osteosynthesis—Metallic bone screws
YY 0018-2016 Implants for osteosynthesis—Metallic bone screws
YY/T 0343-2002 Liquid penetrant inspection of metallic surgical implants
YY 0605.9-2007 Implants for surgery—Metallic materials—Part 9:Wrought high nitrogen stainless steel
YY 0605.9-2015 Implants for surgery—Metallic materials—Part 9:Wrought high nitrogen stainless steel
YY/T 0640-2008 Non-active surgical implants—General requirements
YY/T 0640-2016 Non-active surgical implants—General requirements
YY/T 0662-2008 Implants for surgery—Metal bone screws with asymmetrical thread and spherical under-surface—Mechanical requirements and test methods
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 1504-2016 Implants for surgery—Test method for determining the axial pullout strength of metallic bone screws
YY/T 1505-2016 Implant for surgery—Test method for determining the self-tapping performance of metallic bone screws
YY/T 1506-2016 Implants for surgery—Test method for driving torque of metallic bone screws
YY 0018-2026 Implants for osteosynthesis—Metallic bone screws
GB 4234.1-2026 Implants for surgery—Metallic materials—Part 1:Wrought stainless steel
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