GB 12264-1990
Replaced
YY/T 0345.1-2020
Active
Industry standards-Medicine
YY/T 0345.1-2020 Implants for surgery—Metallic skeletal pins and wires—Part 1:General requirements
YY/T 0345.1-2020 Implants for surgery—Metallic skeletal pins and wires—Part 1:General requirements
Basic Information
Standard Code:
YY/T 0345.1-2020
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:
2020-06-30
Implement Date:
2021-06-01
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技术委员会(SAC/TC 110/SC 1)
Pages:
7 pages
Scope
YY/T 0345的本部分规定了骨科手术用金属骨针的通用要求。
本部分适用于骨科手术用金属骨针,不适用于捆绑和缠绕的金属丝。
Development Information
Drafting Units:
天津市医疗器械质量监督检验中心、北京市富乐科技开发有限公司、常州市康辉医疗器械有限公司、创生医疗器械(中国)有限公司
Drafting Persons:
朱进清、马金竹、白云生、樊国平、陶凯、方琴、陈长胜、杨群
Replace the following standards
Referenced Standards
YY/T 0640-2016 Non-active surgical implants—General requirements
ISO 5832-2
ISO 5832-3
ISO 5832-14
GB/T 228.1-2010 Metallic materials—Tensile testing—Part 1:Method of test at room temperature
GB/T 228.1-2021 Metallic materials—Tensile testing—Part 1:Method of test at room temperature
GB 4234.1-2017 Implants for surgery—Metallic materials—Part 1:Wrought stainless steel
GB/T 4334-2008 Corrosion of metals and alloys—Test methods for intergranular corrosion of stainless steels
GB/T 4334-2020 Corrosion of metals and alloys—Test methods for intergranular corrosion of austenitic and ferritic-austenitic (duplex) stainless steels
GB/T 4334.1-2000 Method of 10 per cent oxalic acid etch test for stainless steels
GB/T 4334.2-2000 Method of ferric sulfate-sulfuric acid test for stainless steels
GB/T 4334.3-2000 Method of 65 percent nitric acid test for stainless steels
GB/T 4334.4-2000 Method of nitric-hydrofluoric acid test for stainless steels
GB/T 4334.5-2000 Method of copper sulfate-sulfuric acid test for stainless steels
GB/T 4334.6-2000 Method of 5 per cent sulfuric acid test for stainless steels
GB/T 4334.6-2015 Test method for stainless steels in 5% sulfuric acid
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 23102-2008 Implants for surgery—Metallic materials—Wrought titanium-6aluminium-7niobium alloy
YY/T 0605.5-2007 Implants for surgery—Metallic materials—Part 5:Wrought cobalt-chromium-tungsten-nickel alloy
YY/T 0605.6-2007 Implants for surgery—Metallic materials—Part 6:Wrought cobalt-nickel-chromium-molybdenum alloy
YY/T 0605.7-2007 Implants for surgery—Metallic materials—Part 7:Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy
YY/T 0605.8-2007 Implants for surgery—Metallic materials—Part 8:Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron alloy
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 0605.12-2007 Implants for surgery—Metallic materials—Part 12:Wrought cobalt-chromium-molybdenum alloy
YY 0605.12-2016 Implants for surgery—Metallic materials—Part 12:Wrought cobalt-chromium-molybdenum alloy
GB 4234.1-2026 Implants for surgery—Metallic materials—Part 1:Wrought stainless steel
Adopt standards
ISO 5838-1:2013
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