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YY/T 0586-2016

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YY/T 0586-2016 英文版 430 购买 现货,9秒内自动发货PDF,有增值税发票。 医用高分子制品 X射线不透性试验方法 有效

   
标准编号: YY/T 0586-2016 (YY/T0586-2016)
中文名称: 医用高分子制品 X射线不透性试验方法
英文名称: (Medical Polymer Co. X-ray opaque Test Method)
行业: 医药行业标准 (推荐)
中标分类: C31
国际标准分类: 11.040.20
发布日期: 2016-01-26
实施日期: 2017-01-01
旧标准 (被替代): YY/T 0586-2005
标准依据: 国家食品药品监督管理总局公告2016年第25号

YY/T 0586-2016
Medical polymer products - X-ray permeability test method
ICS 11.040.20
C31
中华人民共和国医药行业标准
代替YY/T 0586-2005
医用高分子制品
X射线不透性试验方法
2016-01-26发布
2017-01-01实施
国家食品药品监督管理总局 发 布
前言
本标准按照GB/T 1.1-2009给出的规则起草。
本标准代替YY/T 0586-2005《医用高分子制品 X射线不透性试验方法》,与YY/T 0586-2005
《医用高分子制品 X射线不透性试验方法》相比,除编辑性修改外主要技术变化如下.
---删除了方法A,合并了方法B和C;
---增加了与数字图像分析相关的系列术语;
---增加了使用数字图像分析工具测量像素强度的方法;
---修改了样品放置在X射线图像的位置,允许把它放在靠近中心的位置,而不仅仅是中心位置;
---增加了下述程序.若适用,还应考虑临床X射线的台面的影响,用一个材质与之相似,厚度与
之相同的适宜材料来模拟;
---增加了阶梯楔形物可用作用户规定的标准品的说明;
---阐明了X射线曝光程序,指出用人体、产品和特定区域的X射线诊断所用的典型条件完成
X射线曝光;
---更新了报告要求,增加了X射线台面的材料和厚度(若使用)的报告要求。
本标准是在参考ASTMF640-12《测定医用不透射线性标准试验方法》的基础上修订的,在技术方
面与之等同。
请注意本文件的某些内容可能涉及专利。本文件的发布机构不承担识别这些专利的责任。
本标准由全国医用输液器具标准化技术委员会归口。
本标准主要起草单位.山东省医疗器械产品质量检验中心、山东百多安医疗器械有限公司、山东恒
信检测技术开发中心。
本标准主要起草人.许慧、王延明、王常斌、万敏、张海军。
本标准所代替标准的历次版本发布情况为.
---YY/T 0586-2005。
医用高分子制品
X射线不透性试验方法
1 范围
本标准给出的试验方法包括了用基于X射线技术测定原料和产品的不透射线性,包括X光透视检
查、血管造影术、CT(计算机X射线断层扫描技术)、和DEXA(双能X射线吸收),也称为DXA。这些
测量结果可指示医用高分子制品在人体内的定位。
不透射线性的测定是通过使用或不使用身体模拟物,定性比较试验样品图像和用户规定的标准品,
或使用或不使用身体模拟物,定量测量试验样品图像和用户规定的标准品图像之间光密度或像素强
度差。
注.作为方法标准,本标准未规定X射线可探测的可接收准则,但为了方便标准的使用者,附录 A推荐了可接受
准则。
2 规范性引用文件
下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件,仅注日期的版本适用于本文
件。凡是不注日期的引用文件,其最新版本(包括所有的修改单)适用于本文件。
GB 3880.1-2006 一般工业用铝及铝合金板、带材 第1部分.一般要求
3 术语和定义
下列术语和定义适用于本文件。
3.1
身体模拟物 bodymimic
用来模拟适宜的X射线通过人体的特定部位衰减的一片材料、一个人体模型、一具(人的)尸体或
一个动物。
注.其他的身体模拟物也可能适用。
3.2
数字分辨率 digitalresolution
数字图像中每英寸的像素数。
注.数字分辨率可能在x和y方向上不同。
3.3
灰度级范围 grayscalerange
数字图像中分辩出的像素强度的水平数。
注.8位灰度级图像中通常是256水平。
3.4
光密度 opticaldensity
通过光密度计测定的光密度值的范围;在本试验方法中期望的范围是0.50~1.50。

YY/T 0586-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Medical polymer products –
Test methods of radiopacity
X射线不透性试验方法
ISSUED ON. JANUARY 26, 2016
IMPLEMENTED ON. JANUARY 1, 2017
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 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 ... 13
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.
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,
Medical polymer products –
Test methods of radiopacity
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.
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.
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.
A comparison standard selected by the user.
NOTE. This standard may be an existing medical product or a material in a particular form, it
may be a commercially available standard, or it may be one developed by the user.
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
settings are those appropriate for the product and for the particular area of body
interest (for example, leg, heart, and so forth). The radiopacity of the test specimen
and user-defined standard is evaluated in terms of the image background (with or
without the use of a body mimic).
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. This method allows for comparison with or
without the use of a body mimic. Comparisons without the use of a body mimic should
the human body.
5.2 These methods allow for both qualitative and quantitative evaluation in different
comparative situations.
6 Apparatus
6.1 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)
An appropriate animal, or portion of appropriate animal, with which to perform the tests
may be used.
6.3.2 Cadaver
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.
7.2 Product
The product or specific part or section of the product may be utilized in any desired
configuration.
NOTE. For plastics, a 2.0-mm thick sheet of material is often molded especially for testing.
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. For example, each X-ray image is made at a specified voltage, current, time
contrast and brightness, that are typical of those used in the X-ray diagnosis of humans.
Preferred settings are those appropriate for the product and for the particular area of
body interest (for example, leg, heart, and so forth).
8.2 Imaging conditions shall be described in the test report.
9 Procedure
9.1 Test specimen placement
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.
9.2 X-ray exposure
Complete 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.
If using film, the exposure shall be of such duration that an optical density of 0.8 to 1.2
is obtained for the background.
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.
the pixel intensity of the background. Compare two pixel intensities.
10 Report
10.1 The report shall include the following information.
a) all test equipment, including source type, filter type, detector type, machine
geometry, machine type and model numbers, and film type and resolution (if film
is used) or imaging system resolution (if digital analysis is used);
the source-to-detector distance, the object-to-detector distance, and, if film is
used, the focus-film distance and film exposure settings;
c) if applica...
   
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