YY/T 0586-2016 Translated English of Chinese Standard (YYT 0586-2016, YY/T0586-2016, YYT0586-2016): Medical polymer products - Test methods of radiopacityThe test methods in this Standard cover the determination of the radiopacity of materials and products utilizing X-ray based techniques, including fluoroscopy, angiography, CT (computed tomography) and DEXA (dual energy X-ray absorptiometry), also known as DXA. The results of these measurements are an indication of the likelihood of locating the product within the human body. |
Contents
| 3 | |
Scope | 5 |
Summary of test methods | 7 |
Test specimens | 8 |
Imaging conditions | 9 |
Report | 11 |
Annex A informative Description | 13 |
Common terms and phrases
aluminium applicable area of body body mimic cadaver clinical X-ray table densitometer density or pixel diagnosis of humans difference in optical difference Subtract difference The difference digital analysis method digital analysis program digital image analysis digital resolution document exposure using conditions film or digital grayscale level human body image analysis tools image(s Imaging conditions include the manufacturer’s location and dimensions manufacturer’s name material and thickness material of thickness materials and dimensions Measure the background Measure the pixel measured at multiple medical device Medical polymer products methods of radiopacity model number Optical density difference optical density units particular area Pixel intensity difference points and averaged Precision and bias Qualitative analysis quantitative Quantitative analysis regions or objects required if digital Shandong specific specified voltage specimen and user-defined Standard replaces step wedge Test methods test specimen thickness similar torso user-defined standard X-ray diagnosis X-ray exposure X-ray film X-ray image area X-ray imaging system YY/T