oSIST prEN IEC 61223-3-8:2022

Evaluation and routine testing in medical imaging departments - Part 3-8: Acceptance and constancy tests - Imaging performance of X-ray equipment for radiography and radioscopy

Essais d'évaluation et de routine dans les services d'imagerie médicale - Partie 3-8: Essais d'acceptation et de constance - Performance d'imagerie des appareils à rayonnement X pour la radiographie et la radioscopie

Vrednotenje in rutinsko preskušanje v medicinskih oddelkih za slikanje - 3-8. del: Preskusi sprejemljivosti in konstantnosti - Slikovni učinek rentgenske opreme za radiografijo in radioskopijo

General Information

• Status: Not Published
• Public Enquiry End Date: 06-Oct-2022
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 27-Jul-2022
• Due Date: 14-Dec-2022
• Completion Date: 06-Oct-2022
• Ref Project: prEN IEC 61223-3-8:2022 - Evaluation and routine testing in medical imaging departments - Part 3-8: Acceptance and constancy tests - Imaging performance of X-ray equipment for radiography and radioscopy

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN IEC 61223-3-8:2022
01-oktober-2022
Vrednotenje in rutinsko preskušanje v medicinskih oddelkih za slikanje - 3-8. del:
Preskusi sprejemljivosti in konstantnosti - Slikovni učinek rentgenske opreme za
radiografijo in radioskopijo
Evaluation and routine testing in medical imaging departments - Part 3-8: Acceptance
and constancy tests - Imaging performance of X-ray equipment for radiography and
radioscopy
Essais d'évaluation et de routine dans les services d'imagerie médicale - Partie 3-8:
Essais d'acceptation et de constance - Performance d'imagerie des appareils à
rayonnement X pour la radiographie et la radioscopie
Ta slovenski standard je istoveten z: prEN IEC 61223-3-8:2022
ICS:
11.040.50 Radiografska oprema Radiographic equipment
oSIST prEN IEC 61223-3-8:2022 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN IEC 61223-3-8:2022

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oSIST prEN IEC 61223-3-8:2022
62B/1283/CDV

COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 61223-3-8 ED1
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2022-07-15 2022-10-07
SUPERSEDES DOCUMENTS:
62B/1240/CD, 62B/1253A/CC

IEC SC 62B : DIAGNOSTIC IMAGING EQUIPMENT
SECRETARIAT: SECRETARY:
Germany Ms Regina Geierhofer
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:

SC 62C
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.

TITLE:
Evaluation and routine testing in medical imaging departments - Part 3-8: Acceptance and constancy
tests - Imaging performance of X-ray equipment for radiography and radioscopy

PROPOSED STABILITY DATE: 2026

NOTE FROM TC/SC OFFICERS:

Copyright © 2022 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to download this
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.

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oSIST prEN IEC 61223-3-8:2022
62B/1283/CDV – 2 – IEC CDV 61223-3-8 © IEC:2022
1 CONTENTS
2
3 FOREWORD . 8
4 INTRODUCTION . 10
5 1 Scope and object . 11
6 2 Normative references . 11
7 3 Terms, definitions, symbols and abbreviated terms . 12
8 3.1 Terms and definitions. 12
9 3.2 Symbols and abbreviated terms . 20
10 4 General aspects of ACCEPTANCE TESTS . 21
11 4.1 General . 21
12 4.2 Levels of requirements . 21
13 4.2.1 General . 21
14 4.2.2 Local regulatory requirements . 21
15 4.2.3 Contractual requirements. 21
16 4.2.4 MANUFACTURER specifications . 22
17 4.3 General conditions in test procedures . 22
18 4.4 Documents and data for the tests. 22
19 4.5 Test conditions . 22
20 4.6 Scope of tests . 26
21 4.7 Test equipment including PHANTOMS and TEST DEVICES . 26
22 4.7.1 General . 26
23 4.7.2 Analysis software . 26
24 4.7.3 Viewing conditions . 26
25 4.7.4 High-voltage measuring instrument . 26
26 4.7.5 DOSIMETER . 26
27 4.7.6 PHANTOMS, TEST DEVICES and their application . 27
28 4.7.7 DSA PHANTOM . 29
29 4.8 Evaluating the test results . 29
30 5 Specific aspects of CONSTANCY TESTING . 29
31 5.1 General . 29
32 5.2 Establishment of BASELINE VALUES . 29
33 5.3 CONSTANCY TESTING and BASIC CHECKS . 30
34 5.4 Frequency of CONSTANCY TESTS . 30
35 6 Summary of tests for X-RAY EQUIPMENT . 30
36 7 Requirements and test methods . 32
37 7.1 General . 32
38 7.2 Functional properties . 32
39 7.2.1 Test requirements . 32
40 7.2.2 Test method for ACCEPTANCE TEST. 33
41 7.2.3 Test method for CONSTANCY TEST . 33
42 7.3 IMAGE DISPLAY DEVICE performance . 33
43 7.3.1 Test requirements . 33
44 7.3.2 Test method for ACCEPTANCE TEST. 33
45 7.3.3 Test method for CONSTANCY TEST . 34
46 7.4 X-RAY TUBE VOLTAGE . 34
47 7.4.1 Test requirements . 34

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48 7.4.2 Test method for ACCEPTANCE TEST. 34
49 7.4.3 Test method for CONSTANCY TEST . 35
50 7.5 X-RAY TUBE CURRENT or CURRENT TIME PRODUCT . 35
51 7.5.1 Test requirements . 35
52 7.5.2 Test method for ACCEPTANCE TEST. 35
53 7.5.3 Test method for CONSTANCY TEST . 35
54 7.6 HALF-VALUE LAYER of the X-RAY SOURCE ASSEMBLY . 35
55 7.6.1 Test requirements . 35
56 7.6.2 Test method for ACCEPTANCE TEST. 35
57 7.6.3 Test method for CONSTANCY TEST . 36
58 7.7 ATTENUATION EQUIVALENT of ADDED FILTERS . 36
59 7.7.1 Test requirements . 36
60 7.7.2 * Test method for ACCEPTANCE TEST . 36
61 7.7.3 Test method for CONSTANCY TEST . 36
62 7.8 * ATTENUATION EQUIVALENT of materials between the PATIENT and the X-RAY
63 IMAGE RECEPTOR . 36
64 7.8.1 Test requirements . 36
65 7.8.2 * Test method for ACCEPTANCE TEST . 36
66 7.8.3 Test method for CONSTANCY TEST . 36
67 7.9 FOCAL SPOT of the X-RAY TUBE . 36
68 7.9.1 Test requirements . 36
69 7.9.2 Test method for ACCEPTANCE TEST. 36
70 7.9.3 Test method for CONSTANCY TEST . 37
71 7.10 Assessing geometrical properties of the GANTRY . 37
72 7.10.1 Test requirements . 37
73 7.10.2 Test method for ACCEPTANCE TEST. 37
74 7.10.3 Test method for CONSTANCY TEST . 37
75 7.11 AUTOMATIC CONTROL SYSTEM - performance . 37
76 7.11.1 Test requirements . 37
77 7.11.2 * Test method for ACCEPTANCE TEST . 37
78 7.11.3 * Test method for CONSTANCY TEST . 37
79 7.12 AUTOMATIC CONTROL SYSTEM - reproducibility . 38
80 7.12.1 Test requirements . 38
81 7.12.2 Test method for ACCEPTANCE TEST. 38
82 7.12.3 Test method for CONSTANCY TEST . 38
83 7.13 * AUTOMATIC CONTROL SYSTEM - NOMINAL SHORTEST IRRADIATION TIME . 38
84 7.13.1 Test requirements . 38
85 7.13.2 * Test method for ACCEPTANCE TEST . 38
86 7.13.3 Test method for CONSTANCY TEST . 38
87 7.14 Correspondence between the X-RAY FIELD and EFFECTIVE IMAGE RECEPTION
88 AREA . 38
89 7.14.1 Test requirements . 38
90 7.14.2 Test method for ACCEPTANCE TEST. 40
91 7.14.3 Test method for CONSTANCY TEST . 41
92 7.15 Accuracy of indication of the LIGHT FIELD-INDICATOR . 41
93 7.15.1 Test requirements . 41
94 7.15.2 Test method for ACCEPTANCE TEST. 41
95 7.15.3 Test method for CONSTANCY TEST . 42
96 7.16 Accuracy of marked and written indications of the X-RAY FIELD size . 43

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97 7.16.1 Test requirements . 43
98 7.16.2 Test method for ACCEPTANCE TEST. 43
99 7.16.3 Test method for CONSTANCY TEST . 43
100 7.17 AIR KERMA RATE at the ENTRANCE PLANE of the X-RAY IMAGE RECEPTOR for
101 RADIOSCOPY . 43
102 7.17.1 Test requirements . 43
103 7.17.2 Test method for ACCEPTANCE TEST. 44
104 7.17.3 Test method for CONSTANCY TEST . 44
105 7.18 REFERENCE AIR KERMA RATE for RADIOSCOPY . 44
106 7.18.1 Test requirements . 44
107 7.18.2 Test method for ACCEPTANCE TEST. 44
108 7.18.3 Test method for CONSTANCY TEST . 46
109 7.19 AIR KERMA at the ENTRANCE PLANE of the X-RAY IMAGE RECEPTOR for
110 RADIOGRAPHY . 46
111 7.19.1 Test requirements . 46
112 7.19.2 Test method for ACCEPTANCE TEST. 46
113 7.19.3 Test method for CONSTANCY TEST . 46
114 7.20 REFERENCE AIR KERMA for SERIAL RADIOGRAPHY . 46
115 7.20.1 Test requirements . 46
116 7.20.2 Test method for ACCEPTANCE TEST. 46
117 7.20.3 Test method for CONSTANCY TEST . 46
118 7.21 Limitation of the REFERENCE AIR KERMA RATE in RADIOSCOPY . 46
119 7.21.1 Test requirements . 46
120 7.21.2 Test method for ACCEPTANCE TEST. 47
121 7.21.3 Test method for CONSTANCY TEST . 47
122 7.22 SPATIAL RESOLUTION for RADIOSCOPY and RADIOGRAPHY . 47
123 7.22.1 Test requirements . 47
124 7.22.2 Test method for ACCEPTANCE TEST. 47
125 7.22.3 Test method for CONSTANCY TEST . 49
126 7.23 LOW CONTRAST RESOLUTION for RADIOSCOPY and RADIOGRAPHY . 50
127 7.23.1 Test requirements . 50
128 7.23.2 Test method for ACCEPTANCE TEST. 50
129 7.23.3 Test method for CONSTANCY TEST . 50
130 7.24 DYNAMIC RANGE for RADIOSCOPY and RADIOGRAPHY . 51
131 7.24.1 Test requirements . 51
132 7.24.2 Test method for ACCEPTANCE TEST. 51
133 7.24.3 Test method for CONSTANCY TEST . 51
134 7.25 DOSE AREA PRODUCT and REFERENCE AIR KERMA (RATE) indicator . 51
135 7.25.1 Test requirements . 51
136 7.25.2 Test method for ACCEPTANCE TEST. 51
137 7.25.3 Test method for CONSTANCY TEST . 52
138 7.26 Back-up timer and safety measures . 52
139 7.26.1 Test requirements . 52
140 7.26.2 Test method for ACCEPTANCE TEST. 52
141 7.26.3 Test method for CONSTANCY TEST . 52
142 7.27 ARTEFACTS . 52
143 7.27.1 Test requirements . 52
144 7.27.2 Test method for ACCEPTANCE TEST. 52
145 7.27.3 Test method for CONSTANCY TEST . 53

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146 7.28 Accuracy of image measuring functions . 53
147 7.28.1 Test requirements . 53
148 7.28.2 Test method for ACCEPTANCE TEST. 53
149 7.28.3 Test method for CONSTANCY TEST . 53
150 7.29 DYNAMIC RANGE for SUBTRACTION IMAGING . 54
151 7.29.1 Test requirements . 54
152 7.29.2 Conditions for testing the SUBTRACTION IMAGING mode . 54
153 7.29.3 Test method for ACCEPTANCE TEST. 54
154 7.29.4 Test method for CONSTANCY TEST . 54
155 7.30 Contrast sensitivity for SUBTRACTION IMAGING . 54
156 7.30.1 Test requirements . 54
157 7.30.2 Test method for ACCEPTANCE TEST. 54
158 7.30.3 Test method for CONSTANCY TEST . 55
159 7.31 SPATIAL RESOLUTION for SUBTRACTION IMAGING . 55
160 7.31.1 Test requirements . 55
161 7.31.2 Test method for ACCEPTANCE TEST. 55
162 7.31.3 Test method for CONSTANCY TEST . 55
163 7.32 ARTEFACTS in SUBTRACTION IMAGING . 55
164 7.32.1 Test requirements . 55
165 7.32.2 Test method for ACCEPTANCE TEST. 55
166 7.32.3 Test method for CONSTANCY TEST . 56
167 7.33 X-RAY IMAGE RECEPTOR EXPOSURE INDEX . 56
168 7.33.1 Test requirements . 56
169 7.33.2 Test method for ACCEPTANCE TEST. 56
170 7.33.3 Test method for CONSTANCY TEST . 57
171 7.34 LEAKAGE RADIATION in the LOADING STATE . 57
172 7.34.1 Test requirements . 57
173 7.34.2 Test method for ACCEPTANCE TEST. 57
174 7.34.3 Test method for CONSTANCY TEST . 58
175 Annex A (informative) General guidance and rationale . 59
176 A.1 Aim and background information . 59
177 A.2 Medical radiological equipment lifecycle testing . 59
178 A.3 Rationale for particular clauses and subclauses . 62
179 Annex B (informative) Use of REFERENCE AIR KERMA and AIR KERMA at the ENTRANCE
180 PLANE of the X-RAY IMAGE RECEPTOR . 65
181 B.1 Introduction . 65
182 B.2 Issues with AIR KERMA at the ENTRANCE PLANE of the X-RAY IMAGE RECEPTOR
183 as a measure of performance. 65
184 B.3 AIR KERMA at the ENTRANCE PLANE of the X-RAY IMAGE RECEPTOR as an
185 ACCEPTANCE TEST or CONSTANCY TEST . 65
186 B.4 REFERENCE AIR KERMA as a measure of performance . 66
187 B.5 REFERENCE AIR KERMA as an ACCEPTANCE TEST . 66
188 Annex C (informative) Assessing clinical protocol performance . 67
189 C.1 Introduction . 67
190 C.2 Discussion . 67
191 Annex D (informative) Examples of TEST DEVICES for image quality evaluation . 68
192 D.1 Introduction . 68
193 D.2 TEST DEVICE according to DIN 6868-150 . 68
194 D.3 Leeds X-ray test objects for RADIOGRAPHY / RADIOSCOPY systems . 68

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195 D.4 LOW CONTRAST RESOLUTION TEST DEVICE of the University of Alabama at
196 Birmingham, USA . 68
197 Annex E (informative) Examples of DSA PHANTOMS . 69
198 E.1 Introduction . 69
199 E.2 DSA PHANTOM without test step for compensation . 69
200 E.3 DSA PHANTOM with test step for compensation . 71
201 Annex F (informative) QUALITY CONTROL in Cone Beam Computed Tomography
202 (CBCT) . 73
203 F.1 Introduction . 73
204 F.2 Image quality parameters . 73
205 F.2.1 Summary of tests for CBCT . 73
206 F.2.2 Uniformity . 74
207 F.2.3 Geometrical precision . 74
208 F.2.4 Voxel density values . 75
209 F.2.5 Noise . 75
210 F.2.6 LOW CONTRAST RESOLUTION . 75
211 F.2.7 SPATIAL RESOLUTION . 76
212 F.3 Tests of RADIATION output . 76
213 F.3.1 DOSE AREA PRODUCT . 77
214 F.3.2 AIR KERMA at the ENTRANCE PLANE of the X-RAY IMAGE RECEPTOR . 78
215 F.3.3 In-phantom Dosimetry Indexes; CTDI metrics . 78
216 F.4 Image quality PHANTOMS . 79
217 Annex G (informative) Guidance for MANUFACTURER supplied QUALITY CONTROL manual . 80
218 G.1 Introduction . 80
219 G.2 Generic considerations for a QUALITY CONTROL manual . 80
220 G.3 Prerequisites for guidance for MANUFACTURER supplied QUALITY CONTROL
221 manual . 80
222 G.3.1 General aspects . 80
223 G.3.2 Objective of test . 81
224 G.3.3 Test methods, test equipment and test objects . 81
225 G.3.4 Frequency of test . 81
226 G.3.5 Acceptance and constancy criteria . 81
227 G.4 Example . 82
228 Annex H (informative) Uncertainty aspects of testing on X-RAY EQUIPMENT for
229 RADIOGRAPHY and RADIOSCOPY . 85
230 H.1 Introduction .
...