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YY/T 1802-2021 English PDF

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YY/T 1802-2021: (Additive manufacturing medical products 3D printing titanium alloy material method metal image evaluation)
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YY/T 1802-2021English199 Add to Cart 3 days [Need to translate] (Additive manufacturing medical products 3D printing titanium alloy material method metal image evaluation) Valid YY/T 1802-2021

PDF similar to YY/T 1802-2021


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Basic data

Standard ID YY/T 1802-2021 (YY/T1802-2021)
Description (Translated English) (Additive manufacturing medical products 3D printing titanium alloy material method metal image evaluation)
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C35
Word Count Estimation 10,194
Issuing agency(ies) State Drug Administration

YY/T 1802-2021: (Additive manufacturing medical products 3D printing titanium alloy material method metal image evaluation)


---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
(Additive manufacturing medical products 3D printing titanium alloy material method metal image evaluation) ICS 110.040.40 C35 People's Republic of China Pharmaceutical Industry Standard Additive Manufacturing of Medical Products 3D Printing Titanium Implants Evaluation method for metal ion precipitation Published on 2021-09-06 2022-09-01 Implementation Released by the State Drug Administration directory Preface I 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Samples and Reagents 1 5 Instruments and equipment 2 6 Test method 2 7 Container Verification 3 8 Report 3 Appendix A (Informative Appendix) Cross-sectional schematic diagram of porous titanium alloy samples for testing 5 Appendix B (informative appendix) Container ion adsorption performance test method 6 Reference 7

foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some content of this document may be patented. The issuing authority of this document assumes no responsibility for identifying these patents. This standard is proposed by the State Drug Administration. This standard is under the jurisdiction of the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices (SAC/TC110). This standard was drafted by. China National Institute for Food and Drug Control, Tianjin Medical Device Quality Supervision and Inspection Center, Sichuan University (Sichuan Medical Biomaterials and Products Inspection Center for Medical Devices), Beijing Aikang Yicheng Medical Equipment Co., Ltd., and Peking University. The main drafters of this standard. Wang Jian, Wang Caimei, Han Qianqian, Yang Zhaopeng, Yuan Tun, Li Yuan, Deng Xiang, Zheng Yufeng, Zhou Meng, Wang Chunren, Liang Jie. Additive Manufacturing of Medical Products 3D Printing Titanium Implants Evaluation method for metal ion precipitation

1 Scope

This standard specifies an in vitro test method for metal ion release from 3D printed titanium alloy implants. This standard applies to the evaluation of metal ion precipitation from 3D printed porous Ti-6Al-4V (TC4) implants.

2 Normative references

The following documents are essential for the application of this document. For dated references, only the dated version applies to this article pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 35351-2017 Additive Manufacturing Terminology Pharmacopoeia of the People's Republic of China (2020 Edition)

3 Terms and Definitions

The terms and definitions defined in GB/T 35351-2017 and the following terms and definitions apply to this document. 3.1 ion precipitation The sample is placed in the solution configured according to 4.3, and the four element ions of titanium, aluminum, vanadium and iron are precipitated under the time and conditions specified in 6.1. Note. Other elements. tin, molybdenum, chromium, manganese, zirconium, nickel, copper, silicon, yttrium refer to the provisions of 3.2 in GB/T 3620.1-2016 to be determined as needed, not as mandatory elements.

4 Samples and Reagents

4.1 Sample The samples selected for testing are fully processed and can represent the preparation process and structure of the final 3D printed product, where the same The preparation process includes the same process category, process parameters, processing direction and post-processing, etc. The same structure includes the same pore structure, pores porosity, precision and surface quality. The size of the test sample is a circular sheet-like structure with a diameter of 20mm and a height of 3mm. For the schematic diagram of the cross-sectional structure of the sample, please refer to Appendix A Center Figure A.1. The test sample should have the same manufacturing, post-processing, cleaning and sterilization process as the final product. 4.2 Blank control A blank control group was set, that is, the extraction medium without the test material. During leaching, place in the same container as the test material and use the same extraction conditions. 4.3 Hank's artificial simulation of body fluids Use the reagents listed in Table 1 to prepare a simulated physiological solution with a pH of 7.4.All reagents should be of superior grade and above, and should not contain Four kinds of ions, Ti, Al, V and Fe, can be used immediately after configuration.

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