This standard provides test methods for determining the X-ray opacity of various medical polymer products using X-ray photography. The measurement results of these methods are used to indicate whether the polymer product can determine its position in the human body. This standard provides three test methods:
——Method A uses the specific difference in optical density between the image of the polymer product and the background on X-ray film or similar to determine the X-ray opacity;
——Method B uses the test piece to Determination of X-ray opacity by comparison with images of standard parts simulating medical devices;
——Method C determines the inherent X-ray opacity of a specific polymer material by measuring its imaging of a plate of specified thickness. This standard does not cover all safety aspects relevant to its application. It is the responsibility of the user of this standard to determine appropriate safety and health practices and to determine the appropriateness of the limited indicators before use.
YY/T 0586-2005 Referenced Document
GB/T 3880-1997 Aluminium and aluminium alloy rolled sheet
YY/T 0586-2005 history
2016YY/T 0586-2016 Medical polymer products-Test methods of radiopacity
2005YY/T 0586-2005 Medical polymer products - Test methods of radiopacity