YY/T 0586-2016Medical polymer products - Test method for radiopacity (English PDF)

Foreword

This Standard is drafted in accordance with the rules given in GB/T 1.1-2009.

This Standard replaces YY/T 0586-2005 "Medical polymer products - Test methods of radiopacity". Compared with YY/T 0586-2005 "Medical polymer products - Test methods of radiopacity", in addition to editorial modifications, the main technical changes are as follows.

- DELETE Method A; COMBINE Method B and Method C;

- ADD series of terms associated with digital image analysis;

- ADD the method to measure the pixel intensity by digital image analysis tools;

- MODIFY the location of the test specimen in the X-ray image to allow it to sit at or near the middle versus only the middle;

- ADD the following procedure. as appropriate, the effect of the clinical X-ray table shall also be included with use of an appropriate material of thickness similar to that used clinically;

- ADD a description that the step wedge may be used as a user-defined standard;

- CLARIFY the X-ray exposure procedure to indicate completion of X-ray exposure using conditions typical of those used in the X-ray diagnosis of humans, the product and for the particular area of interest;

- RENEW the report requirements, by adding the report requirement for the material and thickness of X-ray table (if used).

This Standard is modified on the basis of ASTM F 640-12 "Standard Test Method for Determining Medical Radiometric Transmission" and is technically equivalent.

1 Scope

The 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.

Radiopacity is determined by qualitatively comparing image(s) of a test specimen and a user-defined standard, with or without the use of a body mimic, or quantitatively determining the specific difference in optical density or pixel intensity between the image of a test specimen and the image of a user-defined standard, with or without the use of a body mimic.

NOTE. As a method standard, this Standard does not specify the acceptance criteria for X-ray detectability, but for ease of use, Annex A recommends the acceptance criteria.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all 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 Terms and definitions

The following terms and definitions apply to this document.

4 Summary of test methods

The test specimen is placed so it sits at or near the middle of the X-ray image area in the X-ray imaging system. X-ray images are made at specified voltages, times, and currents that are typical of those used in the X-ray diagnosis of humans

5 Significance and use

5.1 These methods are intended to determine whether a polymer product (a material, product, or part of a product) has the degree of radiopacity desired for its application as a medical device in the human body.

5.2 These methods allow for both qualitative and quantitative evaluation in different comparative situations.

6 Apparatus

7 Test specimens

8 Imaging conditions

8.1 The test shall be performed at appropriate conditions for the imaging system, the product or material, and the area of the body within which the product is intended for use.

8.2 Imaging conditions shall be described in the test report.

9 Procedure

10 Report

10.1 The report shall include the following information.

11 Precision and bias

11.1 The precision and bias of these test methods have not yet been established.

11.2 It is intended to develop data for the overall method and the measurement of density from a round-robin test.