Standard No.:	YY/T 0345.1-2020
English Name:	Implants for surgery—Metallic skeletal pins and wires—Part 1:General requirements
Chinese Name:	外科植入物 金属骨针 第1部分：通用要求
Chinese Classification:	C35    Orthopedic devices
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.40 11.040.40    Implants for surgery, prosthetics and orthotics 11.040.40
Issued by:	National Medical Products Adminstration
Issued on:	2020-06-30
Implemented on:	2021-6-1
Status:	valid
Superseding:	YY/T 0345.1-2011 Implants for surgery—Skeletal pins and wires—Part 1:Material and mechanical requirements
Language:	English
File Format:	PDF
Word Count:	3500 words
Price(USD):	105.0
Delivery:	via email in 1 business day

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