標(biāo)準(zhǔn)編號(hào):	YY 0341.2-2020
中文名稱(chēng):	無(wú)源外科植入物 骨接合與脊柱植入物 第2部分：脊柱植入物特殊要求
英文名稱(chēng):	Non-active surgical implants—Osteosynthesis and spinal implants—Part 2:Particular requirements for spinal implants
中標(biāo)分類(lèi):	C35    矯形外科、骨科器械
行業(yè)分類(lèi):	YY    醫(yī)藥行業(yè)標(biāo)準(zhǔn)
ICS分類(lèi):	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(guó)家藥品監(jiān)督管理局
發(fā)布日期:	2020-09-27
實(shí)施日期:	2022-6-1
標(biāo)準(zhǔn)狀態(tài):	valid
替代舊標(biāo)準(zhǔn):	YY 0341-2009 骨接合用無(wú)源外科金屬植入物通用技術(shù)條件
翻譯語(yǔ)言:	英文
文件格式:	PDF
中文字符數(shù):	16000 字
翻譯價(jià)格(元):	830.0
交付時(shí)間:	付款后 1 個(gè)工作日

Non-active surgical implants - Osteosynthesis and spinal implants - Part 2: Particular requirements for spinal implants 1 Scope This part of YY 0341 specifies the particular requirements for non-active surgical spinal implants (hereinafter referred to as "spinal implants"). In addition to the requirements specified in YY/T 0640, it also specifies the definition, requirements, test methods, manufacturing, sterilization, packaging and information to be supplied by the manufacturer of spinal implants. This part of YY 0341 is applicable to non-active surgical spinal implant except artificial intervertebral disc implants. 2 Normative references The following referenced documents are indispensable for the application of this standard. For dated references, only the edition cited applies. For undated references, the latest edition (including any amendments) applies. GB/T 4340.1 Metallic materials - Vickers hardness test - Part 1: Test method GB/T 10610 Geometrical product specifications (GPS) - Surface texture: Profile method - Rules and procedures for the assessment of surface texture GB/T 14233.2 Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods GB/T 16886.7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals GB 23101.2 Implants for surgery - Hydroxyapatite - Part 2: Coatings of hydroxyapatite YY/T 0343 Liquid penetrant inspection of metallic surgical implants YY/T 0640-2016 Non-active surgical implants - General requirements YY/T 1074 Implants for surgery - Measuring method for pitting corrosion potential on stainless products YY/T 1428 Spinal implants - Relevant terms YY/T 1615 Surgical implants - Anodizing oxide layers on titanium and titanium alloys - General requirements YY/T 1706.1 Implants for surgery - Plasma-sprayed unalloyed titanium coatings on metallic surgical implants - Part 1: General requirements 3 Terms and definitions For the purposes of this document, the terms and definitions given in YY/T 0640-2016 and YY/T 1428 and the following apply. 3.1 non-active surgical spinal implant non-active surgical implant products used to provide support or deformity correction for spine 3.2 coating layer of material used to cover or partially cover the surface of an implant 3.3 anodizing titanium and titanium alloy electrochemical oxidation of titanium and titanium alloy, i.e. the process of forming an oxide layer on the surface under specific process conditions with titanium and titanium alloy as anodes under the action of an external electric field in corresponding electrolyte 4 Requirements

Foreword i 1 Scope 2 Normative references 3 Terms and definitions 4 Requirements 5 Test methods 6 Manufacturing 7 Sterilization 8 Packaging 9 Information to be supplied by the manufacturer Annex A (Informative) Relevant standards for clinically proven acceptable materials Annex B (Informative) List of approved standards for chemical analysis methods Annex C (Informative) Relevant standards for design evaluation and test