GB/T 36983-2018 in English
VALIDPorous tantalum material for surgical implant applications
- Issued on:2018-12-28
- Implemented on:2021-01-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$156.00
《GB/T 36983-2018外科植入物用多孔钽材料》由TC110（全国外科植入物和矫形器械标准化技术委员会）归口，主管部门为国家药品监督管理局。
Introduction
GB/T 36983—2018 Background and significance of standard formulation
This standard was proposed by the State Administration for Market Regulation and is managed by the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices. The drafting units include Chongqing Runze Pharmaceutical Co., Ltd., Tianjin Medical Device Quality Supervision and Inspection Center and many other companies and research institutions, reflecting the results of multi-party collaboration.
Main performance requirements of porous tantalum materials
| Item | Specific requirements | Test method |
|---|---|---|
| Chemical composition | Comply with the provisions of YY/T 0966 to ensure the purity and biocompatibility of the material. | Chemical composition testing is carried out in accordance with YY/T 0966. |
| Porosity | The manufacturer shall specify the porosity of porous tantalum materials, which can be characterized by density percentage or pore volume percentage. | The test methods include mercury intrusion and gas adsorption (GB/T21650.1) and YY/T0988.14. |
| Internal connection | The manufacturer shall specify the average pore intercept or internal connection diameter between pores of porous tantalum materials. | GB/T21650.1 mercury intrusion method determines the internal connection diameter between pores, and YY/T0988.14 determines the average pore intercept. |
Mechanical properties test methods
Compression performance test:
- It is recommended to use cylindrical specimens with an aspect ratio of 1±0.05.
- The test speed should not exceed 1mm/min, and the load-displacement curve should be recorded.
- Calculate the yield strength and compression strength (Formula 3, 4).
Bending performance test:
- It is recommended to use rectangular rod specimens with a length: thickness ratio of 10:1.
- The test speed should not exceed 1mm/min, and the load-displacement curve should be recorded until it breaks.
- Bending strength calculation formula (Formula 5).
Implementation suggestions
Manufacturers should strictly follow the standards for material production and testing to ensure product quality and safety. At the same time, it is recommended to further optimize material properties and improve the success rate of implants in combination with specific clinical needs in actual applications.
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