GB 12264-1990
Replaced
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
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
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
Related Standards
GB 12279-1990
Replaced
GB 12279-1990 Cardiac valve prostheses general technical specification
GB 12417-1990
Replaced
GB 12417-1990 The general technological conditions of surgical metal implant
GB/T 13461-1992
Replaced
GB/T 13461-1992 Synthetic resin blow knee prostheses
GB/T 14191-1993
Replaced
GB/T 14191-1993 Terminology for prosthetics and orthotics
GB 14722-1993
Replaced