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GB/T 36983-2018: Porous tantalum material for surgical implant applications
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GB/T 36983-2018: Porous tantalum material for surgical implant applications

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Porous tantalum material for surgical implant applications ICS 11.040.40 C35 National Standards of People's Republic of China Porous tantalum material for surgical implants Published on.2018-12-28 2021-01-01 implementation State market supervision and administration China National Standardization Administration issued

Content

Foreword I 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Requirements 2 5 Test method 3

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents. This standard was proposed by the State Administration of Markets. 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. Chongqing Runze Pharmaceutical Co., Ltd., Tianjin Medical Device Quality Supervision and Inspection Center, National Food and Drug Administration Center for Medical Device Technology Evaluation of the General Administration of Management, Institute of Applied Electronics, China Academy of Engineering Physics, Chongqing Institute of Standardization, National X-ray digital imaging instrument center, Sichuan Food and Drug Inspection and Testing Institute, First Affiliated Hospital of the Third Military Medical University of the People's Liberation Army Hospital, First Affiliated Hospital of Chongqing Medical University, Southern Medical University, Beijing University of Aeronautics and Astronautics, North China University of Technology, Central South University, Beijing Neurology Institute of Surgery, Ningxia Oriental Industry Co., Ltd., University of Electronic Science and Technology. The main drafters of this standard. Jie Yunfeng, Ma Chunbao, Hao Lina, Ye Lei, Fan Platinum, Zhou Jian, Deng Yangquan, An Junbo, Zhang Shu, Yin Bo, Yang Liu, Huang Wei, Hu Ning, Shi Zhanjun, Wang Jian, Liu Yinghui, Zhang Jiazhen, Sun Jialu, Fan Rongmei, Luo Qing, Wang Zhiqiang, Rong Zuyuan, Li Shigen, Chen Si, Zhang Yazhuo, Yan Jianming. Porous tantalum material for surgical implants

1 Scope

This standard specifies the chemical composition, mechanical properties and microstructure requirements and test methods of porous tantalum materials for surgical implants. This standard applies to porous tantalum materials for surgical implants produced by physical or chemical methods.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management GB/T 21650.1 Determination of pore size distribution and porosity of solid materials - Part 1 GB/T 36984 X-ray CT detection method for porous metal materials for surgical implants YY/T 0966 Surgical Implant Metal Material Pure SY/T 0988.14 Surgical implant coatings - Part 14 ISO 13175-3 Surgical implant calcium phosphate Part 3. Hydroxyapatite and beta-tricalcium phosphate substitutes (Implantsfor surgery-Calciumphosphates-Part 3.Hydroxyapatiteandbeta-tricalciumphosphatebonesubsti- Tutes) ISO 13383-1 Fine ceramics (advanced ceramics, advanced process ceramics) - Microstructures - Part 1 . Grain size and particle size Determination of cloth [Fineceramics (advancedceramics, advancedtechnicalceramics)-Microstructuralcharacter- ization-Part 1.Determinationofgrainsizeandsizedistribution]

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Porous 钽poroustantalum A porous structure base metal material having three-dimensional connected pores. 3.2 Aperture poresize The hole width (such as the diameter of a circular hole or the distance between two pairs of walls of a slit hole) is a representative of the spatial size properties of porous materials. Sex value. 3.3 Macro hole macropore A pore having a pore diameter greater than 10 μm. 3.4 Microporous micropore A hole having a pore diameter of not more than 10 μm. ...