oSIST prEN IEC 61675-2:2024

Radionuclide imaging devices - Characteristics and test conditions - Part 2: Gamma cameras for planar, wholebody, and SPECT imaging

Bildgebende Systeme in der Nuklearmedizin - Merkmale und Prüfbedingungen - Teil 2: Gammakameras für planare Bildgebung, mit Ganzkörper-Zusatz und Gammakameras zur Einzelphotonen-Emissions-Tomographie (SPECT)

Dispositifs d'imagerie par radionucléides - Caractéristiques et conditions d'essai - Partie 2: Gamma-caméras pour l'imagerie planaire, l'imagerie du corps entier et l'imagerie spect

Naprave za opazovanje radioaktivnih elementov - Karakteristike in preskusni pogoji - 2. del: Gama kamere za planarno slikanje, slikanje celega telesa in slikanje SPECT

General Information

• Status: Not Published
• Public Enquiry End Date: 31-Jul-2024
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 05-Jun-2024
• Due Date: 23-Oct-2024
• Ref Project: prEN IEC 61675-2:2024 - Radionuclide imaging devices - Characteristics and test conditions - Part 2: Gamma cameras for planar, wholebody, and SPECT imaging

Relations

• Revises: SIST EN 61675-2:2016 - Radionuclide imaging devices - Characteristics and test conditions - Part 2: Gamma cameras for planar imaging and spect imaging (IEC 61675-2:2015)
• Effective Date: 23-May-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2024
Naprave za opazovanje radioaktivnih elementov - Karakteristike in preskusni
pogoji - 2. del: Gama kamere za planarno slikanje, slikanje celega telesa in slikanje
SPECT
Radionuclide imaging devices - Characteristics and test conditions - Part 2: Gamma
cameras for planar, wholebody, and SPECT imaging
Bildgebende Systeme in der Nuklearmedizin - Merkmale und Prüfbedingungen - Teil 2:
Gammakameras für planare Bildgebung, mit Ganzkörper-Zusatz und Gammakameras
zur Einzelphotonen-Emissions-Tomographie (SPECT)
Dispositifs d'imagerie par radionucléides - Caractéristiques et conditions d'essai - Partie
2: Gamma-caméras pour l'imagerie planaire, l'imagerie du corps entier et l'imagerie
spect
Ta slovenski standard je istoveten z: prEN IEC 61675-2:2024
ICS:
11.040.50 Radiografska oprema Radiographic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

62C/912/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 61675-2 ED3
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2024-05-31 2024-08-23
SUPERSEDES DOCUMENTS:
62C/871/CD, 62C/889A/CC
IEC SC 62C : EQUIPMENT FOR RADIOTHERAPY, NUCLEAR MEDICINE AND RADIATION DOSIMETRY
SECRETARIAT: SECRETARY:
Germany Ms Regina Geierhofer
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:

Other TC/SCs are requested to indicate their interest, if any, in
this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft
for Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.
This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which
they are aware and to provide supporting documentation.
Recipients of this document are invited to submit, with their comments, notification of any relevant “In Some Countries”
clauses to be included should this proposal proceed. Recipients are reminded that the CDV stage is the final stage for
submitting ISC clauses. (SEE AC/22/2007 OR NEW GUIDANCE DOC).

TITLE:
Radionuclide imaging devices - Characteristics and test conditions - Part 2: Gamma cameras for planar,
wholebody, and SPECT imaging
PROPOSED STABILITY DATE: 2031
NOTE FROM TC/SC OFFICERS:
electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions.
You may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without
permission in writing from IEC.

62C/912/CDV – 2 – IEC CDV 61675-2 © IEC 2024
1 CONTENTS
3 FOREWORD . 4
4 INTRODUCTION . 6
5 1 Scope . 7
6 2 Normative references . 7
7 3 Terms and definitions . 7
8 4 Test methods . 15
9 4.1 General . 15
10 4.2 Planar imaging . 16
11 4.2.1 SYSTEM SENSITIVITY . 16
12 4.2.2 SPATIAL RESOLUTION . 18
13 4.2.3 SPATIAL NON-LINEARITY . 23
14 4.2.4 NON-UNIFORMITY OF RESPONSE . 24
15 4.2.5 BAD PIXEL reporting . 27
16 4.2.6 ENERGY RESOLUTION . 28
17 4.2.7 Intrinsic MULTIPLE WINDOW SPATIAL REGISTRATION . 29
18 4.2.8 COUNT RATE performance . 31
19 4.2.9 Shield leakage test . 33
20 4.3 Wholebody imaging . 34
21 4.3.1 Scanning constancy . 34
22 4.3.2 SPATIAL RESOLUTION without scatter . 35
23 4.4 Tomographic imaging (SPECT) . 38
24 4.4.1 Test of PROJECTION geometry . 38
25 4.4.2 Measurement of SPECT SYSTEM SENSITIVITY . 42
26 4.4.3 Scatter measurement . 45
27 4.4.4 SPECT SYSTEM SPATIAL RESOLUTION . 49
28 4.4.5 Whole Body SPECT . 51
29 4.4.6 Tomographic image quality and accuracy . 52
30 5 ACCOMPANYING DOCUMENTS . 62
31 5.1 General . 62
32 5.2 General parameters for GAMMA CAMERAS . 62
33 5.2.1 COLLIMATORS . 62
34 5.2.2 Shield leakage values . 62
35 5.2.3 Pre-set PULSE AMPLITUDE ANALYSER WINDOWS . 62
36 5.2.4 INTRINSIC ENERGY RESOLUTION . 62
37 5.2.5 COLLIMATOR dependent quantities . 62
38 5.2.6 COUNT RATE CHARACTERISTICS . 62
39 5.2.7 Measured COUNT RATE that is 80 % of the corresponding TRUE COUNT
40 RATE . 63
41 5.2.8 Dimensions of the DETECTOR FIELD OF VIEW . 63
42 5.2.9 Non-uniformity characteristics . 63
43 5.2.10 INTRINSIC SPATIAL RESOLUTION (FWHM) of the DETECTOR HEAD without
44 COLLIMATOR . 63
45 5.2.11 INTRINSIC SPATIAL NON-LINEARITY . 63
46 5.2.12 Intrinsic MULTIPLE WINDOW SPATIAL REGISTRATION . 63

IEC CDV 61675-2 © IEC 2024 – 3 – 62C/912/CDV
47 5.3 GAMMA CAMERA based wholebody imaging system. 63
48 5.3.1 Scanning constancy . 63
49 5.3.2 SPATIAL RESOLUTION . 63
50 5.4 SPECT . 63
51 5.4.1 Calibration measurements of COR . 63
52 5.4.2 Measurement of head tilt . 63
53 5.4.3 Measurement of COLLIMATOR hole misalignment . 63
54 5.4.4 TRANSVERSE RESOLUTION (radial and tangential) . 63
55 5.4.5 AXIAL RESOLUTION. 63
56 5.4.6 Axial PIXEL size . 63
57 5.4.7 Transaxial PIXEL size . 64
58 5.4.8 DETECTOR POSITIONING TIME . 64
59 5.4.9 NORMALIZED VOLUME SENSITIVITY . 64
60 5.4.10 SCATTER FRACTIONS SF and SF . 64
i
61 5.4.11 Wholebody SPECT spatial resolution and performance . 64
62 5.4.12 Image Quality Scan set up and phantom ACTIVITY concentration . 64
63 5.4.13 Image quality . 64
64 5.4.14 Accuracy of ATTENUATION correction and scatter correction . 64
65 5.4.15 Accuracy of SPECT and CT image registration . 64
66 5.4.16 Accuracy of quantitation . 64
67 Bibliography . 65
68 Index of defined terms . 66
70 Figure 1 – Geometry of PROJECTIONS . 9
71 Figure 2 – Cylindrical phantom. 14
72 Figure 3 – Container . 17
73 Figure 4 – Slit phantom . 19
74 Figure 5 – Source arrangement for intrinsic measurements . 20
75 Figure 6 – Calculation of FWHM . 22
76 Figure 7 – Uniform source . 25
77 Figure 8 – Small shielded liquid source . 30
78 Figure 9 – Source positions for scanning constancy for wholebody imagingError! Bookmark not defined.
79 Figure 10 – Cylindrical phantom . 44
80 Figure 11 – Phantom insert with holders for the scatter source . 46
81 Figure 12 – Evaluation of scatter fraction . 48
82 Figure 13 – Reporting transverse resolution . 50
83 Figure 14 – Cross-section of body phantom . 53
84 Figure 15 – Phantom insert with hollow spheres . 55
85 Figure 16: Image quality phantom position for data acquisition with masses . 56
86 Figure 17 – Placement of ROIs in the phantom background . 58
87 Figure 18: Placement of quantitative ROIs in phantom background . 59
89 Table 1 – RADIONUCLIDES and ENERGY WINDOWS to be used for performance
90 measurements . 16
62C/912/CDV – 4 – IEC CDV 61675-2 © IEC 2024
92 INTERNATIONAL ELECTROTECHNICAL COMMISSION
93 ____________
95 RADIONUCLIDE IMAGING DEVICES –
96 CHARACTERISTICS AND TEST CONDITIONS –
98 Part 2: Gamma cameras for planar, wholebody, and SPECT imaging
100 FOREWORD
101 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
102 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
103 international co-operation on all questions concerning standardization in the electrical and electronic fields. To
104 this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
105 Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
106 Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
107 in the subject dealt with may participate in this preparatory work. International, governmental and non -
108 governmental organizations liais
...