YY/T 0586-2016 PDF EnglishUS$85.00 · In stock · Download in 9 seconds
YY/T 0586-2016: Medical polymer products - Test methods of radiopacity Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid YY/T 0586: Historical versions
Similar standardsYY/T 0586-2016: Medical polymer products - Test methods of radiopacity---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0586-2016YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040.20 C 31 Medical polymer products – Test methods of radiopacity Issued on. JANUARY 26, 2016 Implemented on. JANUARY 1, 2017 Issued by. China Food and Drug Administration Table of ContentsForeword... 3 1 Scope... 5 2 Normative references... 5 3 Terms and definitions... 5 4 Summary of test methods... 7 5 Significance and use... 7 6 Apparatus... 7 7 Test specimens... 8 8 Imaging conditions... 9 9 Procedure... 9 10 Report... 11 11 Precision and bias... 11 Annex A (informative) Description... 13ForewordThis 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. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. Issuing organizations of this document shall not be held responsible for identifying any or all such patent rights. This Standard is under the jurisdiction of National Technical Committee of Infusion Equipment for Medical Use. Main drafting organizations of this Standard. Shandong Quality Supervision and Inspection Center for Medical Devices, Shandong Branden Medical Devices Co., Ltd., Shandong Hang Shun Detection Technology Development Center. Main drafters of this Standard; Xu Hui, Wang Yanming, Wang Changbin, Wan Min, Zhang Haijun. The previous version of the standard replaced by this Standard is as follows. - YY/T 0586-2005. Medical polymer products – Test methods of radiopacity1 ScopeThe 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 referencesThe 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 delivery3 Terms and definitionsThe following terms and definitions apply to this document. 3.1 body mimic A piece of material, a phantom, a cadaver or an animal utilized to mimic the appropriate X-ray attenuation through a particular part of the human body. 3.3 grayscale range The number of levels in pixel intensity resolved in the digital image. NOTE. This is normally 256 levels in an 8-bit grayscale image. 3.4 optical density The range of values of optical density as measured by a densitometer; in this test method, the expected range is 0.50 to 1.50. 3.5 optical density difference The difference in optical density units between two regions or objects in an image, reported to at least two digits to the right of the decimal point. 3.6 pixel intensity The grayscale level of a pixel between 0 and 255, as determined by the digital analysis program.4 Summary of test methodsThe 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 humans5 Significance and use5.1 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 Apparatus6.1 X-ray imaging system 6.2 X-ray film or digital image acquisition system The film or digital imaging system shall be appropriate for the imaging conditions used. A grid may be used. 6.3 Body mimic (if used) 6.3.1 Animal An appropriate animal, or portion of appropriate animal, with which to perform the tests may be used. 6.3.5 Step wedge A step wedge may be used as a user-defined standard, if it has the requisite thickness steps. 6.4 Rubber blankets Blankets incorporating X-ray absorbers may be used to mask the image area not covered by the body mimic material (this prevents undercutting). Lead sheets may also be used for masking. 6.5 Back-scatter protection As appropriate with the specific X-ray imaging system. 6.7 Step tablet For calibrating densitometers. This is not required if digital analysis is used.7 Test specimens7.1 Material The material may be in any form. For comparing results between materials, best results will be obtained by utilizing the same form and dimensions for each material.8 Imaging conditions8.1 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 Procedure9.1 Test specimen placement Place the test specimen(s) and the user-defined standard at or near the middle of the X-ray imaging area. If a body mimic is used, place the test specimen(s) and the user- defined standard as appropriate in, on, or under the body mimic. 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. 9.3 Film development Develop the X-ray film in accordance with the manufacturer’s instructions. If a digital analysis method will be used, convert the developed film image(s) to digital format using an appropriate digital scanning or photographic method. 9.4 Qualitative analysis Visually compare the image(s) of the test specimen and the user-defined standard to the background on the film or in the digital image (whether original or converted from film). 9.5.2 Measurement of pixel density (digital) 9.5.2.1 Background Measure the background pixel intensity of the test specimen and the user-defined standard by digital analysis method.10 Report10.1 The report shall include the following information.11 Precision and bias11.1 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. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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