YY 0341.2-2020 Active Industry standards-Medicine

YY 0341.2-2020 Non-active surgical implants—Osteosynthesis and spinal implants—Part 2:Particular requirements for spinal implants

YY 0341.2-2020 Non-active surgical implants—Osteosynthesis and spinal implants—Part 2:Particular requirements for spinal implants

Publish Date: 2020-09-27 Implement Date: 2022-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0341.2-2020
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: 2020-09-27
Implement Date: 2022-06-01
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: 16 pages

Scope

YY 0341的本部分规定了无源外科脊柱植入物(以下简称“脊柱植入物”)的特殊要求,除YY/T 0640规定的要求外,还规定了脊柱植入物的定义、要求、试验方法、制造、灭菌、包装和制造商提供的信息等。
YY 0341的本部分适用于除人工椎间盘植入物以外的无源外科脊柱植入物。

Development Information

Drafting Units:

天津市医疗器械质量监督检验中心、国家药品监督管理局医疗器械技术审评中心、北京市富乐科技开发有限公司

Drafting Persons:

赵丙辉、段青娇、景明、宋铎、孙嘉怿、张家振、胡桓宇、仇万裕

Word Count: 22 Thousand words Pages: 16 pages

Same series standard

Replace the following standards

YY 0341-2009

Referenced Standards

YY/T 0640-2016 Non-active surgical implants—General requirements GB/T 4340.1-1999 Metallic materials—Vickers hardness test—Part 1:Test method GB/T 4340.1-2009 Metallic materials—Vickers hardness test—Part 1:Test method GB/T 4340.1-2024 Metallic materials—Vickers hardness test—Part 1:Test method GB/T 10610-1998 Geometrical product Specifications(GPS)—Surface texture:Profile method—Rules and procedures for the assessment of surface texture GB/T 10610-2009 Geometrical Product Specifications(GPS)—Surface texture:Profile method—Rules and procedures for the assessment of surface texture GB/T 14233.2-1993 Infusion, transfusion, injction equipment for medical use—Part 2:Biological test methods GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals GB 23101.2-2008 Implants for surgery—Hydroxyapatite—Part 2:Coatings of hydroxyapatite YY/T 0343-2002 Liquid penetrant inspection of metallic surgical implants YY/T 1074-2002 Implants for surgery—Measuring method for pitting corrosion potential on stainless products YY/T 1428-2016 Spinal implants—Relevant terms YY/T 1615-2018 Surgical implants—Anodizing oxide layers on titanium and titanium alloys—General requirements YY/T 1706.1-2020 Implants for surgery—Plasma-sprayed unalloyed titanium coatings on metallic surgical implants—Part 1:General requirements GB/T 14233.2-2025 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods

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