IEC 60522-1-2020 Medical electrical equipment – Diagnostic X-rays – Part 1: Determination of quality equivalent filtration and permanent filtration.
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 BEAU can be removable or irreniovable: 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 BEAU 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!positlon 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 ifl 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 60601-1-3:2008IAMD1:2013 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. 2 Normative references The following documents are referred to in the text in such a way that some or all of their content Constitutes requirements of this document. For dated references, only the edition Cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance IEC 60601-1:2005/AMDI:2012 IEC 60601-1 :2005/AMD2:2020 IEC 60601-1-3:2008, Medical electrical equipment — Part 1-3: General requirements for basic safety and essential performance — Collateral Standard: Radiation protection in diagnostic Xray equipment IEC 60601-1-3:2008IAMD1:2013 IEC TR 60788:2004. Medical electrical equipment — Glossary of defined terms IEC 61674:2012, Medical electrical equipment — Dosimeters with ionization cnambers anotor semiconductor detectors as used in X-ray diagnostic imaging 3 Terms and definitions For the purposes of this document, the terms and definitions given in 1EC60601-1:2005, IEC 60601-1 :2005/AMD1 :2012, IEC 60601-1 :2005/AMD2:2020, IEC 60601-1-3:2008. IEC 60601-1- 3:2008/AMD1 :201 3, IEC TR 60788:2004 and the following apply. ISO and lEG maintain terminological databases for use in standardization at the following addresses: • IEC Electropedia: available at http:llwww.electropedia.org! • ISO Online browsing platform: available at http://www.iso.org!obp 3.1 FILTERING MATERIAL material between the X-RAY TUBE ASSEMBLY and the PATIENT which causes FILTRATION of the X-RAY BEAM 3.2 PERMANENT FILTRATION QUALITY EQUIVALENT FILTRATION effected in an X-RAY TUBE ASSEMBLY by permanently fixed materials intercepting the X-RAY BEAM, that are not intended to be removed for any application and are not provided with means for removal in NORMAL USE.IEC 60522-1 pdf download.