標(biāo)準(zhǔn)編號:	YY/T 0345.1-2020
中文名稱:	外科植入物 金屬骨針 第1部分：通用要求
英文名稱:	Implants for surgery—Metallic skeletal pins and wires—Part 1:General requirements
中標(biāo)分類:	C35    矯形外科、骨科器械
行業(yè)分類:	YY    醫(yī)藥行業(yè)標(biāo)準(zhǔn)
ICS分類:	11.040.40 11.040.40    外科植入物、假體和矯形 11.040.40
發(fā)布機(jī)構(gòu):	國家藥品監(jiān)督管理局
發(fā)布日期:	2020-06-30
實施日期:	2021-6-1
標(biāo)準(zhǔn)狀態(tài):	valid
替代舊標(biāo)準(zhǔn):	YY/T 0345.1-2011 外科植入物 金屬骨針 第1部分：材料和力學(xué)性能要求
翻譯語言:	英文
文件格式:	PDF
中文字符數(shù):	7000 字
翻譯價格(元):	490.0
交付時間:	付款后 1 個工作日

YY/T 0345.1-2020 Implants for surgery — Metallic skeletal pins and wires — Part 1: General requirements 1 Scope This part of YY/T 0345 specifies general requirements for metallic skeletal pins and wires for use in bone surgery. This part is applicable to metallic skeletal pins and wires for use in bone surgery, excluding wires for binding and twisting. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 228.1 Metallic materials - Tensile testing - Part 1: Method of test at room temperature (GB/T 228.1-2010, ISO 6892-1:2009, MOD) GB 4234.1 Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (GB 4234.1-2017, ISO 5832-1:2007, MOD) GB/T 4334 Corrosion of metals and alloys - Test methods for intergranular corrosion of stainless steels (GB/T 4334-2008, ISO 3651-1:1998 & ISO 3651-2:1998, MOD) GB/T 13810 Wrought titanium and titanium alloy for surgical implants GB 23102 Implants for surgery - Metallic materials - Wrought titanium -6aluminium-7niobium alloy (GB 23102-2008, ISO 5832-11:1994, IDT) YY/T 0605.5 Implants for surgery - Metallic materials - Part 5: Wrought cobalt-chromium-tungsten-nickel alloy (YY/T 0605.5-2007, ISO 5832-5:2005, IDT) YY/T 0605.6 Implants for surgery - Metallic materials - Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy (YY/T 0605.6-2007, ISO 5832-6:1997, IDT) YY/T 0605.7 Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy (YY/T 0605.7-2007, ISO 5832-7:1994, IDT) YY/T 0605.8 Implants for surgery - Metallic materials - Part 8: Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron alloy (YY/T 0605.8-2007, ISO 5832-8:1997, IDT) YY 0605.9 Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel (YY/T 0605.9-2015, ISO 5832-9:2007, IDT) YY 0605.12 Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum alloy (YY/T 0605.12-2016, ISO 5832-12:2007, IDT) YY/T 0640-2016 Non-active surgical implants - General requirements (ISO 14630:2012, IDT) ISO 5832-2 Implants for surgery - Metallic materials - Part 2: Unalloyed titanium ISO 5832-3 Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy ISO 5832-14 Implants for surgery - Metallic materials - Part 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy 3 Material Skeletal pins and wires shall be made of wrought materials in accordance with GB 4234, GB/T 13810, GB 23102, YY/T 0605.5, YY/T 0605.6, YY/T 0605.7, YY/T 0605.8, YY/T 0605.9, YY/T 0605.12 or ISO 5832-2, ISO 5832-3 and ISO 5832-14.

Foreword II 1 Scope 2 Normative references 3 Material 4 Mechanical properties 5 Method of manufacture 6 Surface quality 7 Sterilization 8 Packaging 9 Information supplied by the manufacturer