IEC60601-1-3PPT课件

1、Claim 本PPT中引用的材料仅供学习法规之用,本人对材料的真实性不负任何责任.同时对引用材料的提供者表示感谢. 请尊重相关公司的权益.第1页/共57页X-ray overview X射线是一种波长极短，能量很大电磁波，它除了具有可见光的一般性质外，还具有自身的一些特性，即穿透作用、电离作用、感光作用、荧光作用及生物效应等。 X射线在医学上的应用有三个方面的内容，即X射线诊断、X射线治疗及X射线防护。用于诊断的X射线机称为诊断X射线机，可以作透视、摄影检查。X射线透视主要依据的是X射线的穿透作用，差别吸收及荧光作用；X射线摄影依据的是X射线的穿透作用，差别吸收及感光作用。CT依据的是射线的穿

2、透作用，差别吸收及荧光作用（或电离，根据检测器不同）本标准涉及的是X射线防护。 X射线的确定性效应(见背景资料) X射线的随机效应 (见背景资料)第2页/共57页General principles for X-ray protection 距离防护。就是尽可能远离射线源。 时间防护。就是尽可能减少可能受到射线照射的时间。 屏蔽防护。就是在射线源的周围设置能够吸收或阻挡射线的物体（称为屏蔽物），尽可能减弱射线到达人体时的强度和能量。最常用的有铝、铁、铅、混凝土等。 加强剂量监测。保证射线源安全运行，避免各种人为事故的发生。 ICRP 的建议: The justification of a pr

3、actice.实践正当性 The optimization of protection.防护最优化 Individual dose and risk limits。个体剂量和风险限制 受检者所受的医疗照射,应遵循放射实践的正当性和放射防护的最优化原则,避免一切不必要的照射,对确实具有正当理由需要进行的医用X射线诊断检查,必须在获取所需诊断信息的同时,把受检者剂量控制到可以合理达到的尽可能低水平。 对操作者或其他人员也适用。 防护要求的趋势：越来越严格。第3页/共57页X-ray typical application第4页/共57页X-Ray Emission第5页/共57页Ideal X-r

4、ay Characteristic 点状X射线源 单能X射线 穿透能力 高斯分布特性第6页/共57页X-Ray SpectrumX-Ray Itensity U2IGenerator should have ripple as low as possible.第7页/共57页29.201 Radiation Quality第8页/共57页29.201 Radiation Quality第9页/共57页29.201 Radiation Quality第10页/共57页29.201 Radiation Quality第11页/共57页29.201 Radiation Quality第12页/共57

5、页29.201 Radiation Quality第13页/共57页29.201 Radiation Quality50 cm25 cm Collimator 14 mm Collimator 20 mm X-ray tube assemblyIonization chamber Reference filter Al第14页/共57页29.201 Radiation Quality100 cm50 cm Collimator 20 mm X-ray source assemblyIonization chamber Reference filter Al第15页/共57页29.202 Lim

6、itation and indication of the extent of the X-ray beam第16页/共57页29.202 Limitation and indication of the extent of the X-ray beam第17页/共57页29.202 Limitation and indication of the extent of the X-ray beam第18页/共57页29.202 Limitation and indication of the extent of the X-ray beam第19页/共57页29.202 Limitation

7、and indication of the extent of the X-ray beam第20页/共57页29.202 Limitation and indication of the extent of the X-ray beam第21页/共57页29.202 Limitation and indication of the extent of the X-ray beam I 1 apertur 1 mm 3 mm 3mm I 2 I max max I 1/4 i1i2i3i41m Distance from focal spot/ 距焦点处1m第22页/共57页29.202 Li

8、mitation and indication of the extent of the X-ray beam第23页/共57页29.202 Limitation and indication of the extent of the X-ray beamlight field 第24页/共57页29.203 Relationship between X-ray field and image reception area第25页/共57页29.203 Relationship between X-ray field and image reception area第26页/共57页29.20

9、3 Relationship between X-ray field and image reception area第27页/共57页29.203 Relationship between X-ray field and image reception areaX-ray fieldImage receptor Area第28页/共57页X射线强度分布射线强度分布第29页/共57页29.204 Leakage radiation第30页/共57页29.204 Leakage radiation第31页/共57页29.204 Leakage radiation第32页/共57页29.204 L

10、eakage radiation第33页/共57页29.204 Leakage radiation第34页/共57页29.205 Focal spot to skin distance第35页/共57页29.205 Focal spot to skin distance第36页/共57页29.205 Focal spot to skin distance第37页/共57页X-ray reduction第38页/共57页29.206 Attenuation of the X-ray beam第39页/共57页29.206 Attenuation of the X-ray beam Informa

11、tion in the Accompanying documents第40页/共57页29.206 Attenuation of the X-ray beam第41页/共57页29.207 Primary protective shielding第42页/共57页29.207 Primary protective shielding第43页/共57页29.207 Primary protective shielding第44页/共57页29.208 Protection against stray radiation第45页/共57页29.208 Protection against stra

12、y radiation第46页/共57页29.208 Protection against stray radiation第47页/共57页29.208 Protection against stray radiation第48页/共57页29.208 Protection against stray radiation第49页/共57页29.208 Protection against stray radiation第50页/共57页IEC60601-1-3 2nd Edition Focus on general requirements for RADIATION PROTECTION

13、requirements apply to all diagnostic X-Ray equipment. most of the clauses have been reduced compared with the first edition Implementation shall be considered in the RISK MANAGEMENT process or by using particular standards.Introduction第51页/共57页 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE o

14、f applies to X-RAY EQUIPMENT and to subassemblies of such equipment, where RADIOLOGICAL IMAGES of a human PATIENT are used for diagnosis, planning or guidance of medical procedures.scopeIEC60601-1-3 2nd Edition第52页/共57页 Terms:Volume changes from 5 to 88Reference to IEC60788IEC60601-1-3 2nd Edition第5

15、3页/共57页ACCOMPANYING DOCUMENTS the ACCOMPANYING DOCUMENTS shall contain information and instructions on how to check and maintain the accuracy of dosimetric indications specified by the MANUFACTURER. Quantitative information Dose indication Clinical protocols Deterministic effects 第54页/共57页Radiation

16、Management enable the management of the delivery of XRADIATION to the PATIENT in a safe and effective way. to enable an acceptable dose-benefit balance to be achieved. Dosimetric indications should be provided with an AUTOMATIC CONTROL SYSTEM. Means shall be provided to reduce the influence of RADIA

17、TION scattered in the PATIENT to the X-RAY IMAGE RECEPTOR in case of significant influence on the image quality. For the INTENDED USE, metrics describing imaging performance shall be defined and specified. nominal focal spot values RADIATION DETECTOR or X-RAY IMAGE RECEPTOR used in X-ray equipment第55页/共57页Clauses 7-13 Corresponding t