1 Scope
This standard provides the methods, by radiography, to determine the radiopacity of various medical polymer products. The results of these measurements are an indication of the likelihood of locating the polymer products within the human body.
This standard provides three kinds of test methods:
Method A - Radiopacity is determined as a specific difference in optical density between the image of the polymer product and the background on the X-ray film or equivalent.
Method B - Radiopacity is determined by comparing the images of the test piece and of a standard piece simulating the medical device.
Method C - The intrinsic radiopacity is determined by measurements made on the image of a slab of a specific thickness of the polymer material.
This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
Note: Along with the development of technology, more state-of-the-art method may be developed that other confirmed equivalent method may also be adopted.
Contents
1 Scope
2 Normative References
3 Terms and Definitions
4 Summary of Test Methods
5 Significance and Use
6 Apparatus
7 Comparison Standards
8 Sample Preparation
9 Test Specimens
10 Test Conditions
11 Procedures of Method A
12 Procedures of Method B
13 Procedures of Method C
14 Calculation
15 Report
16 Precision and Bias
Appendix A (Informative) Variables in Radiopacity of Medical Polymer Products
Appendix B (Informative) Comparison of the Three Test Methods
