1 Scope
The test methods given in this standard cover the determination of radiopacity of raw material and product based on X-ray technology, including x-ray fluoroscopy, angiography, CT (X-ray computed tomography) and DEXA (dual-energy X-ray absorption, also known as DXA). These measuring results may indicate the positioning of medical polymer products in human body.
Radiopacity is determined by qualitatively comparing test sample image and user-defined standard with or without body mimic, or quantitatively measuring optical density or pixel intensity difference between test sample image and user-defined standard image with or without body mimic.
Note: as method standard, this standard does not specify acceptable criteria detectable for X-ray; for the convenience of the user of the standard, the recommended acceptable criteria are given in Appendix A.
2 Normative References
The following documents for the application of this document are essential. Any dated reference, just dated edition applies to this document. For undated references, the latest edition (including any amendments) applies to this document.
GB 3880.1-2006 Wrought Aluminium and Aluminium Alloy Plates, Sheets and Strips for General Engineering - Part 1: Technical Conditions of Delivery
3 Terminologies and Definitions
For the purposes of this document, the following terminologies and definitions apply.
3.1
Body mimic
Foreword i
1 Scope
2 Normative References
3 Terminologies and Definitions
4 Summary of Test Method
5 Significance and Use
6 Equipment
7 Test Sample
8 Imaging Conditions
9 Procedure
10 Report
11 Precision and Bias
Appendix A (Informative) Description
