IEC 60522-1-2020 pdf free download – 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 medicaldiagnostic applications up to a HIGH vOLTAGE of 150 kV.For HIGH vOLTAGEs greater than 50 kV,this document applies to X-— RAYTUBE ASSEMBLIES with tungsten or tungsten-alloy TARGETS only.
NOTE 1 The FLTERING MATERIAL in the X-RAY BEAM can be removable or irremovable;it can be positioned in anyorientation or can have any shape (e.g. tapering thickness) -although usually plane-parallel material，perpendicularto the REFERENCE Axis is applied. Examples of FILTERING MATERALs are ADDED FLTERS ,a PATIENT table (in case ofan under-table X-RAYTUBE ASSEMBLY ), materials in the BEAMLIMITING DEVIcE ,or a breast cOMPRESSION DEvicE .
NOTE 2 The methodologyand statement of compliance given in this document is for flat FLTERS only, but themethodology can be used for any kind of non-flat FiLTER. In that case further data are included in order to produceuseful results,e.g. field size,geometry/position of FILTER ,etc.
This document defines the concept of PERMANENT FILTRATION of X-RAY TUBE ASSEMBLIEs , and itdefines the term FILTERING MATERIAL .
Methods are given to determine the PERMANENT FILTRATION of an X- RAY TUBE ASSEMBLY and fordetermining the QUALITY EQUIVALENT FILTRATION of FILTERING MATERIALS .
ltcontains requirements forstatements of compliance of X-RAY TUBE
ACCOMPANYING DOCUMENTs and for markings on X- RAYTUBE ASSEMBLIEs , and for itf65N6Eandnstatements of compliance of FILTERING MATERIAL .
NOTE 3 This document does not contain requirements for any specific values of PERMANENT FILTRATION. For X-RAYEQUIPMENT used for diagnostic purposes,FILTRATION requirements are given in e.g. IEC 60601-1-3:2008 andIEC 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. lt is not intended as atest 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 contentconstitutes requirements of this document.For dated references, only the edition cited applies.
For undated’references,the latest edition of the referenced document(including anyamendments) applies.
IEC 60601-1:2005,Medical electrical equipment – Part 1: General requirements for basic safetyand essential performance
lEC 60601-1:2005/AMD1:2012IEC 60601-1:2005/AMD2:2020
IEC 60601-1-3:2008, Medical electrical equipment – Part 1-3:General requirements for basicsafety and essential performance – Collateral Standard: Radiation protection in diagnostic X-ray equipment
lEc 60601-1-3:2008/AMD1:2013
IEC TR 60788:2004,Medical electrical equipment – Glossary of defined terms
IEC 61674:2012, Medical electricalequipment – Dosimeters with ionization chambers and/orsemiconductor detectors as used in ×-ray diagnostic imaging
3Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020, IEC 60601-1-3:2008, IEC 60601-1-3:2008/AMD1:2013,IEC TR 60788:2004 and the following apply.
ISo and lEC maintain terminological databases for use in standardization at the followingaddresses:
IEC Electropedia: available at http://www.electropedia.org
Iso Online browsing platform: available at http://www.iso.orglobp
3.1
FILTERING MATERIAL
material between the X-RAY TUBE ASSEMBLY and the PATIENT which causes FILTRATION of the×-RAY BEAM
3.2
PERMANENT FILTRATION
QUALITY EQUIVALENT FILTRATION effected in an X-RAY TUBE ASSEMBLY by permanently fixedmaterials intercepting the X- RAY BEAM , that are not intended to be removed for any applicationand are not provided with means for removal in NORMAL USE
3.3
QUALITY EQuIVALENT FILTRATION
quantitative indication of the FILTRATION effected by one or several layer(s) of referencematerial(s) which, if substituted in a beam of specified’ RADIATION QUALITY under NARROW BEAMCONDITION for the material under consideration, give(s) the same RADIATION QUALITY as for the
material under consideration
Note 1 to entry. The QUALITY EQUIVALENT FLTRATION is expressed in suitable submultiples of the metre togetherwith the reference material(s).
Note 2 to entry: ln this document，RADIATION QUALITYis characterized by its first HALF -VALUELAYER .[SOURCE IEC 60601-1-:2008,3.52,modified-Addition of a new Note 2 to entry.]
4Determination of QuALITY EQUIVALENT FILTRATION
4.1 Alignment of X- RAY TUBE ASSEMBLIEs and of the FILTERS
lf, apart from the X- RAY TUBE ASSEMBLY under test, a reference X-RAY TUBE ASSEMBLY is used,then their REFERENCE AXES shall be aligned.IEC 60522-1 pdf download.