YY/T 0063-2007 医用电气设备 医用诊断X射线管组件 焦点特性

ICSll.040.50

C43

中华人民共和国医药行业标准

YY/T0063一2007/IEC6O336:2005

代替YY/T0063一2000

医用电气设备

医用诊断X射线管组件焦点特性

MedicalelectricalequiPment一

X-raytubeassembliesofrmedicaIdiagnosis一CharacteristicsofofcalsPots

(IEC6O336:2005，IDT)

2007一01一31发布2008一01一01实施

国家食品药品监督管理局发布

YY/T0063一2007/IEC6O336:2005

目次

前言··············‘···················，·········，·，········，，，······················，，································……m

1范围··················································，··············································4·············……1

2规范性引用文件，·····11···················14······，····1····，···················，，，，11·········“‘····……1

3定义和术语······························4·，·······················，··········，·································……1

4焦点特性评价的确定···················4············4················4·，··，··································，··…·1

5焦点照相机装置·········，·································，··，·············，··································……1

6X射线照片的摄取····························································································……5

7线扩散函数的测定······················4·········。·····················，·，，··································，……6

8焦点尺寸的测定·····································，·····，，··············，，··············‘···················……7

9调制传递函数的测定········································4····································，·······…·…二‘9

01焦点星卡射线照片。。·，········，·，·，·······，·，。·········11··，··，·······，·，，，，·，·········，··，··…11

11星卡极限分辨率··，···········································4·················，·······，····················……21

12散焦值············4·······，···，········，···································，·······4·····，·····················……41

31替代的测量方法···········，············，，··························，··············，，，，，····················……51

附录A(资料性附录)基准轴的准直····················································，···················……61

附录B(资料性附录)应用数字X射线影像探测器测定焦点特性····1‘1·····，，····················……81

附录c(资料性附录)历史背景·············································，·················，…·…““·‘·…“’91

参考文献·····，···········4····························································，·······························，…22

已定义术语的索引·····，·········，，·······，············，，，····························，··，，，···········，········……23

图1狭缝光阑的基本尺寸···················································，······4·，············，·，，···，······一·2

图2针孔光阑的基本尺寸····，··································，·，············································，·，…·3

图3狭缝和针孔光阑的中心(图中以只标记)关于基准轴的位置···················4·，······4··········……3

图4参照的尺寸和平面···，·，··，·····，·················1·············，，···1··········，·，，·······，，，，，，…4

图5光学密度计狭缝的准直··············，······················，·······································4·4·····，…·6

图6线扩散函数·····，·······················，································································4···……7

图7星卡的基本尺寸········，·······················，············································，，，·········……11

图8星卡的中心(图中以x标记)关于基准轴的位置··································4················……21

图9最小调制区示意图·，·，················································，·····························4··…·…13

图A.1基准轴和评价方向·····················，，·············，································4··············……61

图A.2实际焦点在影像接收面上的投影·，····，，，·············，·······，，··········，·······················……61

图C.1典型小焦点X射线管的LSFs(<。3)·····························‘·······························一·02

图C.2典型大焦点X射线管的LSFs()。.3)··，···········。······································，·····……02

图c.3对应于图cZI_sFs的MTF，·······································，································一·02

表1焦点x射线照片的放大倍率·····，··，，1，··，···二···1，··········，，，，，，····‘·····，·，，。。。】···，，……”，，’，4’·‘4

表2加载因素··········，·····································，，····················································……5

yy/T0063一2007/IEC60336:2005

表3焦点标称值相应焦点尺寸的最大允许值·······1·，。。-··········，，1········，，，，·······‘·，。。···，······1一8

表4调制传递函数的标准放大倍率······························，·…·，..··……，……01

表5星卡极限分辨率的标准放大倍率·················································，··············，······一41

表6确定散焦值的加载因素················，····················，···················.········.·...····……51

表C.1焦点规定特性的评价方法················································，·，，·..…，...·……，，二，.，21

YY/T0063一2007八EC60336:2005

前言

本标准等同采用国际电工委员会标准EIC6o336:2。。5《医用电气设备—医用诊断X射线管组

件—焦点特性》。

本标准代替YY/T。。63一2。。。《医用诊断X射线管组件焦点特性》，自本标准实施之日起，

YY/Too63一2000《医用诊断x射线管组件焦点特性》废止。

本标准与YY/T0063一2000相比主要变化如下:

—将标准名称由《医用诊断X射线管组件焦点特性》改为《医用电气设备医用诊断X射线管

组件焦点特性》;

—焦点照相机尺寸和准直公差作了调整;

—使用线扩散函数法作为测定焦点的基本方法;

—测量焦点时不考虑焦点的变形;

—以最大允许值代替焦点标称值允许值的范围;

—允许与本标准同等的其他测量方法。

本标准的附录A、附录B、附录C为资料性附录。

本标准由国家食品药品监督管理局提出。

本标准由全国医用X线设备及用具标准化分技术委员会归口。

本标准起草单位:杭州万东电子有限公司。

本标准主要起草人:胡有成、田丰、俞晓妹。

本标准所代替标准的历次版本发布情况为:

—YY/T0063一1991;

—YY/TOO63一2000。

YY/T0063一2007/IEC6O336:2005

医用电气设备

医用诊断X射线管组件焦点特性

范围

本标准适用于工作x射钱管电压不高于200kV(包括200kv)医用诊断x射钱管组件的焦点。

本标准叙述评价焦点特性的试验方法和描述符合性的方法。

2规范性引用文件

下列文件中的条款通过本标准的引用而成为本标准的条款。凡是注日期的引用文件，其随后所有

的修改单(不包括勘误的内容)或修订版均不适用于本标准，然而，鼓励根据本标准达成协议的各方研究

是否可使用这些文件的最新版本。凡是不注日期的引用文件，其最新版本适用于本标准。

YY/To064医用诊断旋转阳极X射线管电、热、负载特性(YY/ToO64一2004，IEC6o613:1989，

IDT)

IEC60417一DB:2002设备用图形符号，，

IEC6O788:2004医用电气设备—定义的术语

定义和术语

对本标准，EIC6O788和以下给出的术语一起适用。

星卡极限分辨率starpatternresolutionlimit

作为x射线管热点一个特性，在特定的测定条件下能分辨的最高空间频率。

焦点特性评价的确定

41焦点特性陈述

焦点特性应按长度和宽度二个垂直评价方向予以陈述。见图A，1。

4.ZX射线管组件的纵轴

通常，纵轴能被清楚地识别。如果x射线f组件没有一个可以确认的纵轴或它以其他方式被制造商

规定，纵轴应连同焦点特性一起被规定。

4.3X射线管组件基准轴

如无其他规定，若准轴与纵轴垂直并通过实际焦点的中心与x射践管组件纵轴相交。

4.4焦点长度的评价方向

焦点长度的评价方向是在x射钱管组件的签准轴和纵轴所在平面内与基准轴垂直。

45焦点宽度的评价方向

焦点宽度的评价方向是与x射线份组件的纵轴垂直并与基准轴垂直。

焦点照相机装t

5.1概述

本章叙述了用于拍摄焦点狭组射线照片的照相机的设计要求，它用于按照第8章测定热点尺寸和按

1)“DB’’引用EIC在线的数据库.

YY/T0063一2007/IEC60336:2005

照第9章测定调制传通函数。

本章还叙述用于拍摄焦点针孔射践照片的照相机的设计要求。

5.2试验设备

5.2.1狭缝照相机

狭缝照相机的光阑应以高衰减性能材料制造且应符合图1所给的尺寸。

合适的材料如:

—钨;

—钮;

—含铂01写的金铂合金;

—含锌01%的钨徕合金;

—含铱01%的铂铱合金。

单位为毫米

未按比例绘制

\泊甫

圈1狭缝光闻的墓本尺寸

52.2针孔照相机

针孔照相机的光阑应以高衰减性能材料制造且应符合图2所给的尺寸。

合适的材料如:

—钨;

一—担;

—含铂01%的金铂合金;

—含徕01%的钨徕合金;

—含铱01%的铂铱合金。

YY/T0063一2007/IEC60336:2005

单位为毫米

未按比例绘制

圈2针孔光阂的苍本尺寸

5.2.3x射线摄影胶片

焦点狭缝射线照片或焦点针孔射线照片应用微粒X射线摄影胶片拍摄，例如牙科X射线摄影用胶片，不

带增感屏。

5.3试验布局

5.3.1狭缝或针孔光闻垂直于基准轴的位t

狭缝或针孔光阑应按图3放置，其中心到基准轴的距离应在每01omm的m为。.Zmm的范围内。

。

圈3狭缝和针孔光阂的中心(图中以x标记)关于蓦准轴的位里

5.3.2狭缝或针孔光阂沿苍准轴的位t

狭缝或针孔光阑人射面与若准平面的距离应使实际热点外缘放大倍率沿鑫准轴的变化不超过士5%

(见图4)。

即:

每loomm的m:P<smm和k<srnm;

式中:

k—从鑫准平面到离狭缝或针孔光阑的实际焦点最远边缘的距离;

P—从若准平面到离狭缝或针孔光阑的实际焦点最近边缘的距离;

。—从苍准平面到光阑人射面的距离;

，—从光阑的人射面到影像接收面的距离;

E—由，/。给出的放大倍率。

YY/T0063一2007/IEC60336:2005

从点点到狭缝或针孔光阑的距离应不小于100mm。

有效焦点

f)\基准平面

斗\

狭缝或针孔光喇的

入射面

基准轴

形位接收面

圈4参照的尺寸和平面

5.3.3狭缝或针孔光阂的方位

对称轴(见图1和图)2应与甚准轴一致，所形成的角度小于1。。

对于拍摄一对偏点狭缝x射故照片，狭缝的光阑应被放置成使狭缝的长度与评价方向垂直，误差在

士1。以内。

534X射线摄影胶片的位里

x射钱摄影胶片宜放置在影像接收面中与鑫准轴垂直，误差在士1之“内，且与狭缝或针孔光阑的人射面

的距离依照表1相应的放大倍率确定。放大倍率E应准确到士3%之内。

裹1热点X射线照片的放大倍率

燕点标称位广放大倍率(E=，/，)“

介轰0.4E)3

0.4<了<工工E)2

1.1(fE妻1

见8.3。

b见图4。

54服相机装t的总不确定度

测量焦点时焦点照相机装置引起的总不确定度应不超过士5%。

YY/T0063一ZOD7/IEC6O336:2005

6X射线照片的摄取

61概述

本章叙述焦点狭缝射钱服片和焦点针孔射缝照片的摄取。

包括符合本标准的焦点狭缝射钱照片和焦点针孔射线照片的表示方法。

62操作条件

62.1焦点狭缝射线照片和焦点针孔射线照片

焦点狭缝射钱照片和焦点针孔射效照片应使用第5章叙述的焦点照相机摄取。第8章描述了由焦点狭绮

射钱欣片测定焦点尺寸的要求;第9章描述了测定调制传递函数的要求。

焦点针孔射线照片仅用于展示燕点的方向、对称性和辐射强度的分布。

6.2.Zx射线管组件

x射线管应装在为使其能正常使用而规定的x射线管管套中或具有等效试验结果和运行条件的装置中。

不应使用减少X射线输出量的附加滤过，除非证明附加池过不明显影响线扩散函数。但是，所有正

常使用的x射雌管组件附属材料都应安装。

6.2.3加载因素

应根据表2中的恒定加载因素摄取X射线摄影用或计算机断层摄影用的x射线，组件的狭缝x射线暇片

或热点针孔x射线照片。

对旋转阳极x射线管，阳极应以相应摄影额定容.规定的最高阳极转速旋转。

6.2.4规定的加载因康

如果根据表2的加载因斑没有包括在所测x射线管的摄影额定容.内或不符合x射线，的规定正常使

用的典型的专用数值，加级因索与它们相应的特定条件有关。这时拍摄热点狭绪射线照片或热点针孔射线照

片所用的加载因康应与其特性一起陈述。

在特殊情况下，给出多个加载条件下的热点的特性是适合的。

表2加载因素

标称X射线，电压

x射钱管电压呀光时间x射钱份功率

kV

U<75标称X射线管电压

除CI外的75镇U镇15075kV根据YY/T。。64规定

取决于光密度的要求，

X射线摄影50纬标称x射雌管的05%阳极标称输入

150<U镇200见6.3.3

电压功率

CT120kV

6.2.5特定的布局

如果，为了拍摄适当的焦点射线照片，采用特定的布局调整和安置狭缝照相机和x射线管组件或采用特

定的电气条件或加截条件，应在符合性声明中与其余特性一起加以详细陈述。

6.3拍摄焦点狭缝射线照片或焦点针孔射线服片

6.3.1拍摄焦点狭缝射线照片

应根据6.2叙述的操作条件拍摄一对焦点狭缝射线照片。

6.3.2拍摄焦点