YY/T 1615-2018 Active Industry standards-Medicine

YY/T 1615-2018 Surgical implants—Anodizing oxide layers on titanium and titanium alloys—General requirements

YY/T 1615-2018 Surgical implants—Anodizing oxide layers on titanium and titanium alloys—General requirements

Publish Date: 2018-11-07 Implement Date: 2019-11-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1615-2018

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: 2018-11-07

Implement Date: 2019-11-01

Pages: 8 pages

Scope

This standard specifies the terminology, definitions, and performance requirements of the effective surface of anodized titanium and titanium alloy films for surgical implants, as well as the test methods.
This standard applies to anodized titanium and titanium alloy products that undergo an oxidation reaction on their surfaces when an external electric field is applied in a corresponding electrolyte solution according to the principle of electrolysis.
This standard does not apply to surfaces treated by anodizing processes aimed at adding non-base elements, or to various surfaces modified by physical or other chemical methods on the products' surfaces.

Development Information

Word Count: 12 Thousand words Pages: 8 pages

Referenced Standards

YY/T 1552-2017 Implants for surgery—Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods 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 6463-1986 Metallic and other non-organic coatings—Review of methods of measurement of thickness GB/T 6463-2005 Metallic and other inorganic coatings—Review of methods of measurement of thickness 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 GB/T 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity GB/T 16886.5-2017 Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity GB/T 17359-1998 General specification of X-ray EDS Quantitative analysis for EPMA and SEM GB/T 17359-2012 Microbeam analysis—Quantitative analysis using energy dispersive spectrometry GB/T 17359-2023 Microbeam analysis—Quantitative analysis using energy-dispersive spectrometry (EDS) for elements with an atomic number of 11 (Na) or above

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