YY/T 0586-2016 English PDF (YYT0586-2016)

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YY/T 0586-2016: Medical polymer products - Test methods of radiopacity
YY/T 0586-2016
Medical polymer products - X-ray permeability test method
ICS 11.040.20
C31
People's Republic of China pharmaceutical industry standards
Replaced YY/T 0586-2005
Medical polymer products
X - ray impermeability test method
2016-01-26 release
2017-01-01 implementation
State Food and Drug Administration released
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0586-2005 "medical polymer products X-ray impermeability test method", and YY/T 0586-2005
"Medical polymer X-ray impermeability test methods" compared to editorial changes in addition to the main technical changes are as follows.
--- Removed Method A, amalgamated Method B and C;
--- Added a series of terms related to digital image analysis;
--- Increased the use of digital image analysis tools to measure pixel intensity method;
--- Modify the sample placed in the position of the X-ray image, allowing it to be placed near the center, not just the center;
--- Increased the following procedure.If applicable, should also consider the impact of clinical X-ray tabletop, with a similar material, the thickness and
The same suitable material to simulate;
--- Added step wedge can be used as a user-specified standard instructions;
--- Clarified X-ray exposure procedures, pointing out that the typical conditions used for X-ray diagnosis of the human body, the product, and the particular area were completed
X-ray exposure;
--- Updated reporting requirements, increasing the reporting requirements for X-ray table material and thickness (if used).
This standard is based on the reference ASTMF640-12 "Determination of medical radiopaque standard test method" based on the revised technical side
The same is true
Please note that some of this document may be patentable. The issuing agencies of this document do not bear the responsibility of identifying these patents.
This standard by the National Medical Devices Standardization Technical Committee centralized.
The main drafting units of this standard. Shandong Province Medical Device Product Quality Inspection Center, Shandong 100 Duo An Medical Devices Co., Ltd., Shandong Heng
Letter detection technology development center.
The main drafters of this standard. Xu Hui, Wang Yanming, Wang Changbin, Wan Min, Zhang Haijun.
This standard replaces the standards previously issued as.
--- YY/T 0586-2005.
Medical polymer products
X - ray impermeability test method
1 Scope
The test methods given in this standard include the use of X-ray-based techniques to determine the radiopacity of raw materials and products, including X-ray fluoroscopy
Check, angiography, CT (computed tomography), and DEXA (dual energy X-ray absorption), also known as DXA. These ones
The measurement results can indicate the positioning of medical polymer products in the human body.
Non-radiopaque assays qualitatively compare test sample images to user-defined standards with or without body simulants,
Or with or without body simulants, to quantitatively measure the optical density or pixel intensity between a test sample image and a user defined standard image
Poor degree.
Note. As a method standard, this standard does not provide X-ray detectable acceptance criteria, but for the convenience of standard users, Appendix A recommended acceptable
Guidelines.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
General industrial aluminum and aluminum alloy plates, strips - Part 1. General requirements
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Body mimic
A piece of material used to simulate the attenuation of a suitable X-ray through a specific part of the body, a mannequin, a (human) body or
An animal.
Note. Other body simulants may be suitable.
3.2
Digital resolution digitalresolution
The number of pixels per inch in the digital image.
Note. The digital resolution may differ in the x and y directions.
3.3
Grayscale range grayscalerange
The number of levels of pixel intensity resolved in a digital image.
Note. The 8-bit grayscale image is usually 256 levels.
3.4
Optical density
The range of optical density values as determined by an optical densitometer; the desired range for this test method is from 0.50 to 1.50.