BS-EN-61675-2-1998 IEC-61675-2-1998.pdf

BRITISH STANDARD BS EN 61675-2:1998 IEC 61675-2:1998 Incorporating Amendment No. 1 Radionuclide imaging devices Characteristics and test conditions Part 2: Single photon emission computer tomographs The European Standard EN 61675-2:1998, with the incorporation of amendment A1:2005, has the status of a British Standard ICS 11.040.50 ? Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 01:05:54 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 61675-2:1998 This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 May 1998 © BSI 6 May 2005 ISBN 0 580 29682 2 National foreword This British Standard is the official English language version of EN 61675- 2:1998, including amendment A1:2005. It is identical with IEC 61675-2:1998, Edition 1.1:2004 which comprises Edition 1:1998 consolidated by the incorporation of amendment 1:2004. The UK participation in its preparation was entrusted to Technical Committee CH/82, Nuclear medicine instrumentation, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 47 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No.DateComments 155836 May 2005Indicated by a sideline. Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 01:05:54 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN 61675-2 February 1998 + A1 February 2005 ICS 11.040.50 English version Radionuclide imaging devices Characteristics and test conditions Part 2: Single photon emission computer tomographs (includes amendment A1:2005) (IEC 61675-2:1998 + A1:2004) Dispositifs dimagerie par radionucléides Caractéristiques et conditions dessais Partie 2: Systèmes de tomographie demission à photon unique (inclut lamendement A1:2005) (CEI 61675-2:1998 + A1:2004) Bildgebende Systeme in der Nuklearmedizin Merkmale und Prüfbedingungen Teil 2: Einzelphotonen-Emissions- Tomographie (enthält Änderung A1:2005) (IEC 61675-2:1998 + A1:2004) This European Standard was approved by CENELEC on 1998-01-01, amendment A1 was approved by CENELEC on 2005-02-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CENELEC member into its own language and notified to the Central Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. CENELEC European Committee for Electrotechnical Standardization Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B-1050 Brussels © 1998 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 61675-2:1998 + A1:2005 E Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 01:05:54 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 61675-2:1998 © BSI 6 May 20052 Foreword The text of document 62C/206/FDIS, future edition 1 of IEC 61675-2, prepared by SC 62C, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 61675-2 on 1998-01-01. The following dates were fixed: Annexes designated “normative” are part of the body of the standard. Annexes designated “informative” are given for information only. In this standard, Annex ZA is normative and Annex A is informative. Annex ZA has been added by CENELEC. Endorsement notice The text of the International Standard IEC 61675-2:1998 was approved by CENELEC as a European Standard without any modification. Foreword to amendment A1 The text of document 62C/378/FDIS, future amendment 1 to IEC 61675-2:1998, prepared by SC 62C, Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as amendment A1 to EN 61675-2:1998 on 2005-02-01. The following dates were fixed: Endorsement notice The text of the amendment 1:2004 to the International Standard IEC 61675-2:1998 was approved by CENELEC as an amendment to the European Standard without any modification. latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop)1998-11-01 latest date by which the national standards conflicting with the EN have to be withdrawn(dow)1998-11-01 latest date by which the amendment has to be implemented at national level by publication of an identical national standard or by endorsement(dop)2005-11-01 latest date by which the national standards conflicting with the amendment have to be withdrawn(dow)2008-02-01 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 01:05:54 GMT+00:00 2006, Uncontrolled Copy, (c) BSI CONTENTS 1 General 4 1.1 Scope and object.4 1.2 Normative references 4 2 Terminology and definitions 5 3 Test methods 11 3.1 Calibration measurements . 12 3.2 Measurement of COLLIMATOR hole misalignment. 13 3.3 Measurement of SPECT system SENSITIVITY 13 3.4 Scatter 15 3.5 Measurement of SPECT non-uniformity of response. 17 3.6 SPECT system SPATIAL RESOLUTION. 17 3.7 Test methods for single photon computer tomographs operated in coincidence detection mode. 18 4 ACCOMPANYING DOCUMENTS. 31 Annex A Index of defined terms.45 Annex ZA (normative) Normative references to international publications with their corresponding European publications47 Figure 1 Geometry of PROJECTIONS.34 Figure 2 Cylindrical head phantom35 Figure 3 Phantom insert with holders for the scatter source 36 Figure 4 Evaluation of SCATTER FRACTION37 Figure 5 Reporting TRANSVERSE RESOLUTION.38 Figure 6 Evaluation of FWHM.39 Figure 7 Evaluation of EQUIVALENT WIDTH (EW) 40 Figure 8 Phantom insert with hollow spheres 41 Figure 9 Cross-section of body phantom.42 Figure 10 Arm phantom42 Figure 11 Phantom configuration for COUNT RATE measurements according to 3.7.5.3.1.2 .43 Figure 12 Scheme of the evaluation of COUNT LOSS correction.43 Figure 13 Phantom insert for the evaluation of ATTENUATION correction .44 Page 3 EN 616752:1998 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 01:05:54 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 1 General 1.1 Scope and object This part of IEC 61675 specifies terminology and test methods for describing the character- istics of Anger type rotational GAMMA CAMERA SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHS (SPECT), equipped with parallel hole collimators. As these systems are based on Anger type GAMMA CAMERAS this part of IEC 61675 shall be used in conjunction with IEC 60789. These systems consist of a gantry system, single or multiple DETECTOR HEADS and a computer system together with acquisition, recording, and display devices. This part of IEC 61675-2 also specifies test conditions for declaring the characteristics of single photon computer tomographs operated in coincidence mode as well as in single photon mode. The test methods specified for coincidence mode are based on the test methods for dedicated PET tomographs as described in IEC 61675-1 to reflect as well as possible the clinical use of coincidence detection. Tests have been modified to reflect the limited sensitivity and COUNT RATE CHARACTERISTICS of the single photon computer tomographs operated in coincidence detection mode only when needed. The test methods specified in this part of IEC 61675 have been selected to reflect as much as possible the clinical use of Anger type rotational GAMMA CAMERA SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHS (SPECT). It is intended that the test methods be carried out by manufacturers thereby enabling them to describe the characteristics of SPECT systems on a common basis. No test has been specified to characterize the uniformity of reconstructed images because all methods known so far will mostly reflect the noise of the image. 1.2 Normative references The following referenced documents are indispensable for the application 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 60788:1984, Medical radiology Terminology IEC 60789:1992, Characteristics and test conditions of radionuclide imaging devices Anger type gamma cameras IEC 61675-1, Radionuclide imaging devices Characteristics and test conditions Part 1: Positron emission tomographs Page 4 EN 616752:1998 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 01:05:54 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 2 Terminology and definitions For the purposes of this part of IEC 61675 the definitions given in IEC 60788, IEC 60789 and IEC 61675-1 (some of which are repeated in this clause), and the following definitions apply. Defined terms are printed in small capital letters. 2.1 SYSTEM AXIS Axis of symmetry characterized by geometrical and physical properties of the arrangement of the system NOTE The SYSTEM AXIS of a GAMMA CAMERA with rotating detectors is the axis of rotation. 2.1.1 COORDINATE SYSTEMS 2.1.2 FIXED COORDINATE SYSTEM Cartesian system with axes X, Y, and Z, Z being the SYSTEM AXIS. The origin of the FIXED COORDINATE SYSTEM is defined by the centre of the TOMOGRAPHIC VOLUME (see Figure 1). The SYSTEM AXIS is orthogonal to all TRANSVERSE SLICES. 2.1.3 COORDINATE SYSTEM OF PROJECTION Cartesian system of the IMAGE MATRIX of each two-dimensional projection with axes Xp and Yp (defined by the axes of the IMAGE MATRIX). The Yp axis and the projection of the system axis onto the detector front face have to be in parallel. The origin of the COORDINATE SYSTEM OF PROJECTION is the centre of the IMAGE MATRIX (see Figure 1). 2.1.4 CENTRE OF ROTATION (COR) Origin of that COORDINATE SYSTEM, which describes the PROJECTIONS of a TRANSVERSE SLICE with respect to their orientation in space NOTE The CENTRE OF ROTATION of a TRANSVERSE SLICE is given by the intersection of the SYSTEM AXIS with the mid-plane of the corresponding OBJECT SLICE. 2.1.5 OFFSET Deviation of the position of the PROJECTION of the COR (X'p) from Xp = 0. (See Figure 1) 2.2 TOMOGRAPHY (see annex A) 2.2.1 TRANSVERSE TOMOGRAPHY In TRANSVERSE TOMOGRAPHY the three-dimensional object is sliced by physical methods, e.g. collimation, into a stack of OBJECT SLICES, which are considered as being two-dimensional and independent from each other. The transverse image planes are perpendicular to the SYSTEM AXIS. 2.2.2 EMISSION COMPUTED TOMOGRAPHY (ECT) Imaging method for the representation of the spatial distribution of incorporated RADIONUCLIDES in selected two-dimensional SLICES through the object Page 5 EN 616752:1998 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 01:05:54 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 2.2.2.1 PROJECTION Transformation of a three-dimensional object into its two-dimensional image or of a two- dimensional object into its one-dimensional image, by integrating the physical property which determines the image along the direction of the PROJECTION BEAM NOTE This process is mathematically described by line integrals in the direction of projection and called the Radon-transform. 2.2.2.2 PROJECTION BEAM Determines the smallest possible volume in which the physical property which determines the image is integrated during the measurement process. Its shape is limited by the SPATIAL RESOLUTION in all three dimensions. NOTE In SPECT the PROJECTION BEAM usually has the shape of a long thin diverging cone. 2.2.2.3 PROJECTION ANGLE Angle at which the PROJECTION is measured or acquired NOTE For illustration see Figure 1. 2.2.2.4 SINOGRAM Two-dimensional display of all one-dimensional PROJECTIONS of an object slice, as a function of the PROJECTION ANGLE The PROJECTION ANGLE is displayed on the ordinate. The linear PROJECTION coordinate is displayed on the abscissa. 2.2.2.5 OBJECT SLICE A slice in the object. The physical property of this slice that determines the measured information is displayed in the tomographic image. 2.2.2.6 IMAGE PLANE A plane assigned to a plane in the OBJECT SLICE NOTE Usually the IMAGE PLANE is the mid-plane of the corresponding OBJECT SLICE. 2.2.2.7 TOMOGRAPHIC VOLUME Ensemble of all volume elements which contribute to the measured PROJECTIONS for all PROJECTION ANGLES NOTE For a rotating GAMMA CAMERA with a circular field of view the TOMOGRAPHIC VOLUME is a sphere provided that the radius of rotation is larger than the radius of the field of view. For a rectangular field of view, the TOMOGRAPHIC VOLUME is a cylinder. 2.2.2.7.1 TRANSVERSE FIELD OF VIEW Dimensions of a slice through the TOMOGRAPHIC VOLUME, perpendicular to the SYSTEM AXIS. For a circular TRANSVERSE FIELD OF VIEW it is described by its diameter. NOTE For non-cylindrical TOMOGRAPHIC VOLUMES the TRANSVERSE FIELD OF VIEW may depend on the axial position of the slice. Page 6 EN 616752:1998 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 01:05:54 GMT+00:00 2006,