1. Rationale
Improvements to the standard were identified by the sub-committee to allow the standard to be consistent with current practice and more usable. Specifically the following was identified: (1) Separate methods B and C are not needed and make the document cumbersome (2) The location of the test specimen in the X-ray image should be allowed to sit away from the middle of the image. (3)The effect of the clinical X-ray table should also be included, when applicable, with use of an appropriate material of thickness similar to that used clinically. (4) The calibration standard for the digital analysis (standard that creates a clear and completely opaque areas) is problematic with fluoroscopic units and does not add to the comparability of data between labs. (5) The step wedge should be identified as a user-defined standard. (6)The X-ray exposure procedure should be of clinical relevance and completed using conditions typical of those used in the X-ray diagnosis of humans, the product and for the particular area of interest. (7) The report should require the material and thickness representing the X-ray table used, when applicable.
Keywords
implants; radiopacity; surgical applications; surgical devices; surgical implants; test methods; X-ray;
Citing ASTM Standards
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