YY/T 1706.1-2020Implants for surgery—Plasma-sprayed unalloyed titanium coatings on metallic surgical implants - Part 1: General requirements (English PDF)

Foreword

YY/T 1706 "Surgical implants metal surgical implants plasma sprayed pure titanium coating" is divided into the following parts.

---Part 1: General requirements; This part is Part 1 of YY/T 1706.

This part uses the redrafting method to modify and adopt ISO 13179-1:2014 "Plasma sprayed pure titanium for surgical plant metal surgical implants Coating Part 1: General Requirements.

Compared with ISO 13179-1:2014, except for editorial changes, the main technical changes in this part are as follows.

---Regarding normative reference documents, this standard has made adjustments with technical differences to adapt to my country's technical conditions and adjustments.

The situation is collectively reflected in Chapter 2 "Normative Reference Documents", and the specific adjustments are as follows.

- Replace ISO 4287 with GB/T 3505 which is equivalent to adopting international standards;

- Replace ISO 10993-1 with GB/T 16886.1 which is equivalent to the international standard;

- Replace ISO 14971 with YY/T 0316 which is equivalent to the international standard;

- Use YY/T 0988.2 instead of ASTM F1580;

- Replace ASTM F1147 with YY/T 0988.11;

- Use YY/T 0988.12 instead of ASTM F1044;

- Use YY/T 0988.13 instead of ASTM F1160;

- Replace ASTM F1854 with YY/T 0988.14;

- Replace ASTM F1978 with YY/T 0988.15;

--- Chemical analysis step (4.2.3) adds "or recognized analysis method (existing ISO method or method recommended by national standards)" to Adapt to my country's national conditions and facilitate the implementation of standards.

Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.

Introduction

So far, there is no surgical implant material that has no rejection in the human body. However, materials prepared with reference to this standard should be used in long-term clinical applications.

In use, it has been shown that when the application is appropriate, an acceptable level of biological response can be expected.

1 Scope

This part of YY/T 1706 specifies the general requirements for plasma sprayed pure titanium coatings on metal surgical implants. This section applies to atmospheric or vacuum plasma spraying.

This section does not apply to coatings processed by materials other than pure titanium materials, or coatings processed by other technologies than plasma spraying technology. Industrial coating.

Note. The quality management system specified in YY/T 0287 can be used. Refer to ISO /IEC 17025 for the requirements of testing laboratory capabilities.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document. For undated references, the latest version (including all amendments) applies to this document.

GB/T 3505 Product Geometric Technical Specification (GPS) Surface Structure Profile Method Terms, Definitions and Surface Structure Parameters (GB/T 3505-2009, ISO 4287:1997, IDT)

GB/T 16886.1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing in the Process of Risk Management (GB/T 16886.1- 2011, ISO 10993-1:2009)

YY/T 0316 Application of medical device risk management to medical devices (YY/T 0316-2016, ISO 14971:2007)

YY/T 0988.2 Surgical implant coating Part 2: Titanium and titanium-6 aluminum-4 vanadium alloy powder

YY/T 0988.11 Surgical implant coating Part 11: Calcium phosphate coating and metal coating tensile test method

YY/T 0988.12 Surgical implant coatings Part 12: Calcium phosphate coating and metal coating shear test method

YY/T 0988.13 Surgical implant coating Part 13: Shearing and bending of calcium phosphate, metal and calcium phosphate/metal composite coating Fatigue test method

YY/T 0988.14 Surgical implant coatings. Part 14: Stereological evaluation methods for porous coatings

YY/T 0988.15 Surgical implant coatings Part 15: Test method for wear resistance of metal thermal spray coatings

ISO 5832-2 Metallic materials for surgical implants Part 2: Pure titanium

3 Terms and definitions

The following terms and definitions apply to this document.

4 Requirements

5 Test report

The test report should include at least the following information.

a) The identification of the test sample includes the source, date of receipt, and form;

b) The number of test samples used in each test;

c) References of the test methods used;

d) Deviation from the test method used, if applicable;

e) Special conditions observed in the test;

f) The reason for excluding data from all data;

g) Chemical analysis results (see 4.2);

h) Morphological analysis results (see 4.3);

i) Average static shear strength (see 4.4.2);

j) Shear fatigue strength (see 4.4.3);

k) Average static tensile strength (see 4.4.4);

l) The amount of wear (see 4.4.5);

m) Test date;

n) The identification of the laboratory where the test is conducted;

o) Signatures of laboratory managers and operators. references [1] ISO 5961 Determination of Cadmium by Water Quality Atomic Absorption Spectrometry.

[2] YY/T 0287 Medical device quality management system is used for regulatory requirements.

[3] ISO 16429 Surgical Implant Evaluation of Metal Implant Materials and Medical Devices Long-term Corrosion Behavior Measurement of Open Circuit Potential method.