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GB/T 36984-2018: X-ray CT testing method of the porous metal materials for surgical implant applications
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 36984-2018 | English | 279 |
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X-ray CT testing method of the porous metal materials for surgical implant applications
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GB/T 36984-2018
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Basic data | Standard ID | GB/T 36984-2018 (GB/T36984-2018) | | Description (Translated English) | X-ray CT testing method of the porous metal materials for surgical implant applications | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 14,188 | | Date of Issue | 2018-12-28 | | Date of Implementation | 2021-01-01 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 36984-2018: X-ray CT testing method of the porous metal materials for surgical implant applications
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X--ray CT testing method of the porous metal materials for surgical implant applications
ICS 11.040.40
C35
National Standards of People's Republic of China
X-ray of porous metal material for surgical implants
CT detection method
Published on.2018-12-28
2021-01-01 implementation
State market supervision and administration
China National Standardization Administration issued
Content
Foreword III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Principle of the method 2
5 Tester requirements 2
6 Equipment Requirements 2
7 CT inspection process flow 3
8 image quality requirements 5
9 CT image analysis of porous metal performance parameters 5
10 Test records, reports 7
Appendix A (informative) Common rules for connectivity 9
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. State Food and Drug Administration, Medical Device Technology Evaluation Center, University of Electronic Science and Technology, Tianjin Medical
Instrument Quality Supervision and Inspection Center, Institute of Applied Electronics, China Academy of Engineering Physics, Chongqing Runze Pharmaceutical Co., Ltd., Chongqing Municipal Standard
Institute of Chemical Research, Beijing University of Aeronautics and Astronautics, National X-ray Digital Imaging Instrument Center.
The main drafters of this standard. Liu Bin, Fang Liyong, Deng Yangquan, Li Shoutao, Chen Si, Li Jing, Chen Hao, Ye Lei, Fan Platinum, Zhou Jian, Jie Yunfeng,
Hao Lina, Guo Xiaolei, Yan, Aruhan, Luo Qing, Yin Bo, Liu Xiaoyu.
X-ray of porous metal material for surgical implants
CT detection method
1 Scope
This standard specifies the terms and definitions, method principles, and test personnel for X-ray CT testing of porous metal materials for surgical implants.
Requirements, equipment requirements, CT inspection process flow, image quality requirements, CT image analysis of porous metal performance parameters, inspection records, reports, etc.
This standard is applicable to X-ray CT testing of porous metal materials for surgical implants with a thickness of 2mm~30mm.
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 9445 Non-destructive testing personnel qualification and certification
Non-destructive testing - Radiographic film quality - Part 1 . Determination of image quality index of linear image quality
Non-destructive testing - Radiographic film quality - Part 5. Determination of image clarity of two-line image quality
GB/T 29034 Non-Destructive Testing Industrial Computer Tomography (CT) Guide
GB/T 29069 Non-destructive testing industrial computer tomography (CT) system performance test method
GB/T 29070 Non-destructive testing industrial computer tomography (CT) testing general requirements
NB/T 47013.11 Non-destructive testing of pressure equipment - Part 11. X-ray digital imaging
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Surgical implant with porous metal material metalporousmaterialsforsurgicalimplantapplication
A porous structural metal material for surgical implants having three-dimensional connected pores.
3.2
CT detection CTtesting
By X-ray or γ-ray, in the form of two-dimensional tomographic image or three-dimensional image without damage to the detected object
A technique for clearly, accurately, and visually displaying the internal structure, composition, material, and defect condition of an object to be inspected.
3.3
Single image porosity single-layerporosity
The ratio of the area of the pore to the total area of the sample in a single-slice CT scan image.
3.4
Average porosity averageporosityofalscanningimages
All scanned CT slice images were selected, and the porosity of a single image of each slice image was calculated to obtain the mean value.
3.5
3D porosity 3Dporosity
The ratio of the pore volume to the total volume of the sample.
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