SSH EN IEC 60522-1:2021

Medical electrical equipment - Diagnostic X-rays - Part 1: Determination of quality equivalent filtration and permanent filtration

Scope

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.