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GB/T 36984-2018X-ray CT testing method of the porous metal materials for surgical implant applications (English PDF)

外科植入物用多孔金属材料X射线CT检测方法

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

December 28, 2018

Implementation date

January 1, 2021

Scope

GB/T 36984-2018 is the English-translated version of 外科植入物用多孔金属材料X射线CT检测方法.

GB/T 36984-2018 is the Chinese method for examining porous metal materials used in surgical implants by X-ray computed tomography (CT). It defines the material and the key quantities measured, such as single-image porosity, average porosity across all slices and three-dimensional porosity.

It sets the principle of the method, the qualification of test personnel, the equipment requirements, the CT inspection process flow and the image quality requirements, and explains how pore performance parameters are derived by image analysis, with an informative annex on connectivity.

It closes with the content of test records and reports. It applies to porous metal materials 2 mm to 30 mm thick and is used by implant manufacturers and testing laboratories. It was issued on 28 December 2018 and has applied since 1 January 2021.

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Document preview — GB/T 36984-2018

National Standard of the People's Republic of China

ICS: 11.040.40
Classification: C 35

Issued by: State Administration for Market Regulation; Standardization Administration of the PRC

Foreword
1 Scope
2 Normative references
3 Terms and Definitions
4 Principle of the method
5 Tester requirements
6 Equipment Requirements
7 CT inspection process flow
8 image quality requirements
9 CT image analysis of porous metal performance parameters
10 Test records, reports
Appendix A (informative) Common rules for connectivity

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

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 document. 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

A porous structural metal material for surgical implants having three-dimensional connected pores.

3.2 CT detection

By X-ray or gamma-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

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

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

The ratio of the pore volume to the total volume of the sample.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

Normative references

Cited by

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