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现行 IEC 60522-1:2020
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Medical electrical equipment - Diagnostics X-rays - Part 1: Determination of quality equivalent filtration and permanent filtration 医用电气设备诊断X射线第1部分:质量等效过滤和永久过滤的测定
发布日期: 2020-12-04
IEC 60522-1:20 20适用于高达150 kV高压的医疗诊断应用中的X射线管组件和过滤材料。对于大于50 kV的高压,本文件仅适用于带有钨或钨合金靶的X射线管组件。 IEC 60522-1:20 21定义了X射线管组件永久过滤的概念,并定义了术语过滤材料。 给出了确定X射线管组件的永久过滤和确定过滤材料的质量等效过滤的方法。 它包含随附文件中X射线管组件的符合性声明、X射线管组件上的标记以及过滤材料的指示和符合性声明的要求。 IEC 60522-1:20 20取消并取代了1999年发布的IEC 60522第二版。本版构成技术修订版。本版本包括以下与IEC 60522:1999相关的重大技术变更: IEC 60522-1的范围相对于第二版IEC 60522进行了如下变更: a)由于放射治疗标准未参考IEC 60522,放射治疗不再在范围内。因此,高电压被限制在150kV,并且铜不再用作参考材料。 b)虽然IEC 60522:1999仅涵盖永久过滤,但IEC 60522-1也相当普遍地涵盖“过滤入射到患者上的X射线束的材料”。这涉及诸如添加的过滤器、桌面、乳房压迫装置和光束限制装置中的材料。对于这些材料,已经引入了定义的术语过滤材料。 c)为了提供IEC 60522-1内容的技术和科学背景和基本原理,介绍了IEC TR 60522-2。
IEC 60522-1:2020 applies to X-RAY TUBE ASSEMBLIES and to FILTERING MATERIAL, in medical diagnostic applications up to a HIGH VOLTAGE of 150 kV. For HIGH VOLTAGES greater than 50 kV, this document applies to X-RAY TUBE ASSEMBLIES with tungsten or tungsten-alloy TARGETS only.
IEC 60522-1:2021 defines the concept of PERMANENT FILTRATION of X-RAY TUBE ASSEMBLIES, and it defines the term FILTERING MATERIAL.
Methods are given to determine the PERMANENT FILTRATION of an X-RAY TUBE ASSEMBLY and for determining the QUALITY EQUIVALENT FILTRATION of FILTERING MATERIALS.
It contains requirements for statements of compliance of X-RAY TUBE ASSEMBLIES in ACCOMPANYING DOCUMENTS and for markings on X-RAY TUBE ASSEMBLIES, and for indications and statements of compliance of FILTERING MATERIAL.
IEC 60522-1:2020 cancels and replaces the second edition of IEC 60522 published in 1999. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the IEC 60522:1999:
The scope of the IEC 60522-1 has been changed with respect to second edition of the IEC 60522 as follows:
a) As radiotherapy standards do not reference IEC 60522, radiotherapy is no longer in the scope. Consequently, the HIGH VOLTAGE is limited to 150 kV, and copper is no longer used as reference material.
b) While IEC 60522:1999 covers only PERMANENT FILTRATION, IEC 60522-1 also covers quite generally “material filtering the X-RAY BEAM incident on the PATIENT”. This concerns materials like ADDED FILTERS, table-tops, a breast COMPRESSION DEVICE, and materials in the BEAM LIMITING DEVICE. For these materials the defined term FILTERING MATERIAL has been introduced.
c) In order to provide technical and scientific background and rationale on the content of IEC 60522-1, IEC TR 60522-2 was introduced.
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研制信息
归口单位: TC 62/SC 62B
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