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

Publish Date: 2020-06-30 Implement Date: 2021-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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

Word Count: 10 Thousand words Pages: 7 pages

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

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