GB 12264-1990
Replaced
YY/T 1706.1-2020
Active
Industry standards-Medicine
YY/T 1706.1-2020 Implants for surgery—Plasma-sprayed unalloyed titanium coatings on metallic surgical implants—Part 1:General requirements
YY/T 1706.1-2020 Implants for surgery—Plasma-sprayed unalloyed titanium coatings on metallic surgical implants—Part 1:General requirements
Basic Information
Standard Code:
YY/T 1706.1-2020
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:
2020-02-21
Implement Date:
2021-01-01
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(SAC/TC 110)
Pages:
8 pages
Scope
YY/T 1706的本部分规定了金属外科植入物等离子喷涂纯钛涂层的通用要求。
本部分适用于大气或真空等离子喷涂。
本部分不适用于除纯钛材料以外的其他材料加工的涂层,或以等离子喷涂技术以外的其他技术加工的涂层。
注: 可以使用YY/T 0287中规定的质量管理体系。对检测实验室能力的要求可以参考ISO/IEC 17025。
Development Information
Drafting Units:
天津市医疗器械质量监督检验中心、苏州微创关节医疗科技有限公司、北京优材京航生物科技有限公司
Drafting Persons:
张晨、李沅、俞天白、许敏、贺娟、熊震国
Referenced Standards
ISO 5832-2
GB/T 3505-2000 Geometrical product specifications (GPS)—Surface texture:Profile method—Terms, definitions and surface texture parameters
GB/T 3505-2009 Geometrical Product Specifications (GPS)—Surface texture:Profile method—Terms,definitions and surface texture parameters
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
YY/T 0316-2003 Medical devices—Application of risk management to medical devices
YY/T 0316-2008 Medical devices—Application of risk management to medical devices
YY/T 0316-2016 Medical devices—Application of risk management to medical devices
YY/T 0988.2-2016 Coatings of surgical implants—Part 2:Titanium and titanium-6 aluminum-4 vanadium alloy powders
YY/T 0988.11-2016 Coatings of surgical implants—Part 11:Tension testing method of calcium phosphate coating and metallic coatings
YY/T 0988.12-2016 Coatings of surgical implants—Part 12:Shear testing method of calcium phosphate coating and metallic coatings
YY/T 0988.13-2016 Coatings of surgical implants—Part 13:Test method for shear and bending fatigue testing of calcium phosphate and metallic and calcium phosphate/metallic coating
YY/T 0988.14-2016 Coatings of surgical implants—Part 14:Stereological evaluation method of porous coatings
YY/T 0988.15-2016 Coatings of surgical implants—Part 15:Test methord for abrasion resistance testing of metallic thermal spray coatings
YY/T 0316-2000 YY/T 0316-2000 Medical devices - Risk analysis - Part 1: Application of risk analysis
Adopt standards
ISO 13179-1:2014
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