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YY/T 1706.1-2020 English PDF

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YY/T 1706.1-2020: Implants for surgery--Plasma-sprayed unalloyed titanium coatings on metallic surgical implants - Part 1: General requirements
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YY/T 1706.1-2020English149 Add to Cart 3 days [Need to translate] Implants for surgery--Plasma-sprayed unalloyed titanium coatings on metallic surgical implants - Part 1: General requirements Valid YY/T 1706.1-2020

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Standard similar to YY/T 1706.1-2020

YY/T 1860.1   YY/T 1748   YY/T 1705   YY/T 1707   

Basic data

Standard ID YY/T 1706.1-2020 (YY/T1706.1-2020)
Description (Translated English) Implants for surgery--Plasma-sprayed unalloyed titanium coatings on metallic surgical implants - Part 1: General requirements
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C35
Classification of International Standard 11.040.40
Word Count Estimation 8,844
Date of Issue 2020
Date of Implementation 2021-01-01
Issuing agency(ies) State Drug Administration
Summary This standard specifies general requirements for plasma-sprayed pure titanium coatings for metal surgical implants. This standard applies to atmospheric or vacuum plasma spraying. This standard does not apply to coatings made of materials other than pure titanium, or coatings made of other techniques than plasma spraying.

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


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Implants for surgery--Plasma-sprayed unalloyed titanium coatings on metallic surgical implants--Part 1.General requirements ICS 040.40 C35 People's Republic of China Pharmaceutical Industry Standard Surgical implant metal surgical implant plasma Spraying pure titanium coating Part 1.General requirements 2020-02-21 released 2021-01-01 implementation Issued by the State Drug Administration

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 ASTMF1580; ● Replace ASTMF1147 with YY/T 0988.11; ● Use YY/T 0988.12 instead of ASTMF1044; ● Use YY/T 0988.13 instead of ASTMF1160; ● Replace ASTMF1854 with YY/T 0988.14; ● Replace ASTMF1978 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. This part was proposed by the State Drug Administration. This part is under the jurisdiction of the National Standardization Technical Committee for Surgical Implants and Orthopedic Devices (SAC/TC110). Drafting organizations of this section. Tianjin Medical Device Quality Supervision and Inspection Center, Suzhou MicroPort Joint Medical Technology Co., Ltd., Beijing Youcai Beijing Airlines Biological Technology Co., Ltd. The main drafters of this section. Zhang Chen, Li Yuan, Yu Tianbai, Xu Min, He Juan, Xiong Zhenguo.

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. Surgical implant metal surgical implant plasma Spraying pure titanium coating Part 1.General requirements

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 article Pieces. 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. 3.1 Plasma spraying Thermal spraying method using plasma jet to process coating. 3.2 Plasma sprayed pure titanium coating A coating formed by spraying pure titanium on the surface of the substrate through a plasma spraying process.

4 requirements

4.1 Plasma spray powder The powder used in plasma spraying should meet the requirements of YY/T 0988.2. 4.2 Chemical analysis 4.2.1 Chemical composition The chemical composition of the pure titanium plasma spray coating should meet the requirements of Table 1. Note. Although this standard is applicable to both atmospheric and vacuum plasma sprayed coatings, vacuum plasma sprayed coatings may be more chemical than atmospheric plasma sprayed coatings. The component value is low. 4.2.2 Sample preparation For chemical analysis of the coating, at least 5g samples should be taken from the coating deposited on the pure titanium substrate sample, and the pure titanium substrate sample should meet The requirements of ISO 5832-2.If it is impossible to prepare a 5g sample from the coating, the sample weight can be reduced without affecting the chemical analysis. The technique of preparing coating samples should not cause contamination of the coating. If the implant has undergone a cleaning step after spraying the coating, before chemical analysis The same cleaning procedure should be used for the sample. 4.2.3 Chemical analysis steps The content of iron (Fe) element can be inductively coupled plasma atomic emission spectrometry (ICP-AES) in accordance with ASTM E2371 Or recognized analytical methods (existing ISO methods or methods recommended by national standards) for determination. Nitrogen (N), oxygen (O), carbon (C) and hydrogen (H) element content should be determined by the combustion method, which should be recognized as effective. When declaring that the chemical analysis results meet the limit content specified in Table 1, the analysis accuracy of the 95% confidence level should be considered. Example. If the measurement uncertainty of the oxygen (O) element content at the 95% confidence level is 1%, it should be pointed out that the coincidence of the measured value is ≤9%. 4.3 Morphology Taking into account the effectiveness of the morphological test, if possible the test should be carried out on the final product. If the geometry of the final product is not When the morphological test cannot be performed on the final product because the standard requirements can be met, the sample can be used and it should be proved that the sample can represent the final product. The average coating thickness and tolerance should be determined in accordance with YY/T 0988.14, in micrometers (μm). The roughness (Ra or Rt) should be measured in accordance with GB/T 3505, and the unit is micron (μm). The assessment length should be at least 8mm. For coatings with an average thickness ≥300μm, the average pore volume percentage and average pore intercept shall be calculated in accordance with YY/T 0988.14 Measure the average pore volume in different layers of coating thickness according to YY/T 0988.14 ("Tissue Interface Gradient Method") Ratio and average pore intercept. 4.4 Coating mechanical properties 4.4.1 General Each test specified in 4.4.2~4.4.4 should use at least 5 test samples, and the matrix of the test samples should be the same as the matrix of the final product. with. Both the test sample and the final product should be subjected to the same pretreatment (for example, cleaning, sandblasting) and post-treatment (for example, cleaning, sterilization). 4.4.2 Static shear strength When tested in accordance with YY/T 0988.12, the average static shear strength of the coating should be greater than 20MPa. 4.4.3 Shear fatigue strength When tested in accordance with YY/T 0988.13, the maximum shear fatigue stress is at least 10MPa, and the coating should be able to withstand 10 million cycles No failure occurs. 4.4.4 Static tensile strength When tested in accordance with YY/T 0988.11, the average static tensile strength of the surface coating should be greater than 22MPa. 4.4.5 Wear resistance When tested in accordance with YY/T 0988.15, the wear amount of the surface coating after 100 cycles should be less than 65mg. 4.5 Verification control According to YY/T 0316, the chemical composition, morphology and tensile strength of the coating should be regularly controlled within the period determined by the risk analysis. The routine control procedures for coating should specify the type and time interval of each control test. 4.6 Validity of numerical rounding In order to ensure the consistency of all specified numerical ranges under various circumstances, the calculated and observed values should be rounded to two decimal places to be valid digital.

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.

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