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
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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
Pages: 8 pages

Scope

This part of YY/T 1706 specifies the general requirements for plasma sprayed pure titanium coatings on metal surgical implants.
This part is applicable to plasma spraying in atmospheric or vacuum conditions.
This part is not applicable to coatings processed from materials other than pure titanium, or coatings processed by technologies other than plasma spraying.
Note: The quality management system specified in YY/T 0287 may be used. For the requirements on the competence of testing laboratories, reference may be made to ISO/IEC 17025.

Development Information

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

Related Standards

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