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.