Medical electrical equipment. Diagnostic X-rays - Determination of quality equivalent filtration and permanent filtration

Medical electrical equipment. Diagnostic X-rays - Determination of quality equivalent filtration and permanent filtration

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1   Scope

This document 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.

NOTE 1 The filtering material in the X-ray beam can be removable or irremovable; it can be positioned in any orientation or can have any shape (e.g. tapering thickness) – although usually plane-parallel material, perpendicular to the reference axis is applied. Examples of filtering materials are added filters, a patient table (in case of an under-table X-ray tube assembly), materials in the beam limiting device, or a breast compression device.

NOTE 2 The methodology and statement of compliance given in this document is for flat filters only, but the methodology can be used for any kind of non-flat filter. In that case further data are included in order to produce useful results, e.g. field size, geometry/position of filter, etc.

This document 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.

NOTE 3 This document does not contain requirements for any specific values of permanent filtration. For X-ray equipment used for diagnostic purposes, filtration requirements are given in e.g. IEC 60601‑1‑3:2008 and IEC 60601‑1‑3:2008/AMD1:2013 or in the applicable particular standard.

NOTE 4 The method of determination described in this document is suitable as a type test. It is not intended as a test to be applied by the user.