YY/T 1615-2018Implants for surgery - Anodizing oxide layers on titanium and titanium alloys - General requirements (English PDF)
外科植入物 钛及钛合金阳极氧化膜通用要求
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
November 7, 2018
Implementation date
November 1, 2019
Scope
YY/T 1615-2018 is the English-translated version of 外科植入物 钛及钛合金阳极氧化膜通用要求.
YY/T 1615-2018 is the Chinese pharmaceutical industry standard for the anodic oxide layer formed on titanium and titanium alloy surgical implants, the film grown by making the part the anode in an electrolyte.
It gives the terms and definitions and sets the performance requirements and the test methods for the effective surface: the appearance and colour, the thickness and uniformity of the film, its adhesion and abrasion resistance, the corrosion resistance it confers and the residues left from the process. Issued on 7 November 2018, it has applied since 1 November 2019.
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Document preview — YY/T 1615-2018
National Standard of the People's Republic of China
- ICS
- 11.040.40
- Classification
- C 35
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Requirements
- 5 Test method
- Appendix A (Normative Appendix) Scratch Performance Test Method
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the terms and definitions of titanium and titanium alloy anodized films for surgical implants and the performance requirements and test methods for effective surfaces.
This standard is applicable to the use of titanium and titanium alloy products as anodes in the corresponding electrolytes according to the principle of electrolysis.
An anodized film that undergoes an oxidation reaction at the surface.
This standard does not apply to surfaces treated with anodizing processes for the purpose of adding non-matrix elements and by physical or other chemical means.
Various surfaces on which the surface of the product is modified.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 4340.1 Metallic materials - Vickers hardness test - Part 1. Test method Review of GB/T 6463 metal and other inorganic coating thickness measurement methods
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management
GB/T 16886.5 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test
GB/T 17359 microbeam analysis energy spectrum quantitative analysis
YY/T 1552-2017 Surgical implants for open circuit potential measurements of long-term corrosion behavior of metal implant materials and medical devices method
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 Anodized
Metals and their alloys are electrolytically reacted to form an oxide layer by reacting their anode surfaces.
3.2 Anodized oxide film
The oxide layer formed on the surface of the metal and its alloy during electrochemical anodization has protection, identification or other characteristics.
3.3 Anodized titanium and titanium alloy
Electrochemical oxidation of titanium and titanium alloys. Titanium and titanium alloys act as anodes, in the corresponding electrolyte, by the action of an applied electric field, A process in which a process condition forms an oxide layer on its surface.
3.4 Colored anodized film
An anodizing method designed to identify products without the purpose of improving the mechanical properties of the product. Anodizing of titanium and titanium alloys An oxide film having a thickness of several tens of nanometers to several hundreds of nanometers is formed on the surface thereof, and the main component is titanium oxide, which is a transparent interference film and can strongly reflect
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 22 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 4340.1Metallic materials - Vickers hardness test - Part 1: Test method
- GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- GB/T 16886.5Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- GB/T 17359Microbeam analysis - Quantitative analysis using energy-dispersive spectrometry (EDS) for elements with an atomic number of 11 (Na) or above
- YY/T 1552-2017Implants for surgery-Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods
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Related Standards
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 16886.5-2017 — Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
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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