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

Publish Date: 2020-02-21 Implement Date: 2021-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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

Word Count: 14 Thousand words Pages: 8 pages

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

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