SIST EN IEC 61223-3-8:2024

SLOVENSKI STANDARD
01-julij-2024
Vrednotenje in rutinsko preskušanje v medicinskih oddelkih za slikanje - 3-8. del:
Preskusi sprejemljivosti in konstantnosti - Slikovni učinek rentgenske opreme za
radiografijo in radioskopijo (IEC 61223-3-8:2024)
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 (IEC 61223-3-8:2024)
Bewertung und routinemäßige Prüfung in Abteilungen für medizinische Bildgebung - Teil
3-8: Abnahme- und Konstanzprüfungen - Leistungsmerkmale zur Bildgebung von
Röntgeneinrichtungen für Radiographie und Radioskopie (IEC 61223-3-8:2024)
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 (IEC 61223-3-8:2024)
Ta slovenski standard je istoveten z: EN IEC 61223-3-8:2024
ICS:
11.040.50 Radiografska oprema Radiographic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 61223-3-8

NORME EUROPÉENNE
EUROPÄISCHE NORM May 2024
ICS 11.040.50
English Version
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
(IEC 61223-3-8:2024)
Essais d'évaluation et de routine dans les services Bewertung und routinemäßige Prüfung in Abteilungen für
d'imagerie médicale - Partie 3-8: Essais d'acceptation et de medizinische Bildgebung - Teil 3-8: Abnahme- und
constance - Performance d'imagerie des appareils à Konstanzprüfungen - Leistungsmerkmale zur Bildgebung
rayonnement X pour la radiographie et la radioscopie von Röntgeneinrichtungen für Radiographie und
(IEC 61223-3-8:2024) Radioskopie
(IEC 61223-3-8:2024)
This European Standard was approved by CENELEC on 2024-04-30. 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 CEN-CENELEC
Management Centre 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 CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 61223-3-8:2024 E

European foreword
The text of document 62B/1347/FDIS, future edition 1 of IEC 61223-3-8, prepared by SC 62B
"Diagnostic imaging equipment" of IEC/TC 62 "Electrical equipment in medical practice" was
submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 61223-3-8:2024.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2025-01-30
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2027-04-30
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 61223-3-8:2024 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standard indicated:
IEC 60627:2013 NOTE Approved as EN 60627:2015 (not modified)
IEC 61223-3-6:2020 NOTE Approved as EN IEC 61223-3-6:2020 (not modified)
IEC 62220-1-1:2015 NOTE Approved as EN 62220-1-1:2015 (not modified)
IEC 62563-1:2009 NOTE Approved as EN 62563-1:2010 (not modified)
IEC 62563-1:2009/A1:2016 NOTE Approved as EN 62563-1:2010/A1:2016 (not modified)
IEC 62563-1:2009/AMD2:2021 NOTE Approved as EN 62563-1:2010/A2:2021 (not modified)
IEC 62563-2:2021 NOTE Approved as EN IEC 62563-2:2021 (not modified)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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.
NOTE 1  Where an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2  Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cencenelec.eu.
Publication Year Title EN/HD Year
IEC 60336 2020 Medical electrical equipment - X-ray tube EN IEC 60336 2021
assemblies for medical diagnosis - Focal
spot dimensions and related characteristics
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- - + corrigendum Mar. 2010
+ A1 2012 + A1 2013
- - + A12 2014
+ A2 2020 + A2 2021
- - + A13 2024
IEC 60601-1-3 2008 Medical electrical equipment - Part 1-3: EN 60601-1-3 2008
General requirements for basic safety and
essential performance - Collateral
Standard: Radiation protection in
diagnostic X-ray equipment
- - + corrigendum Mar. 2010
+ A1 2013 + A1 2013
- - + AC 2014
- - + A11 2016
+ A2 2021 + A2 2021
IEC 60601-2-43 2022 Medical electrical equipment - Part 2-43: EN IEC 60601-2-43 2023
Particular requirements for the basic safety
and essential performance of X-ray
equipment for interventional procedures
IEC 60601-2-54 2022 Medical electrical equipment - Part 2-54: - -
Particular requirements for the basic safety
and essential performance of X-ray
equipment for radiography and radioscopy
IEC 61267 2005 Medical diagnostic X-ray equipment - EN 61267 2006
Radiation conditions for use in the
determination of characteristics
IEC 61674 2012 Medical electrical equipment - Dosimeters EN 61674 2013
with ionization chambers and/or
semiconductor detectors as used in X-ray
diagnostic imaging
IEC 61676 2023 Medical electrical equipment - Dosimetric EN IEC 61676 2023
instruments used for non-invasive
measurement of X-ray tube voltage in
diagnostic radiology
IEC 62494-1 2008 Medical electrical equipment - Exposure EN 62494-1 2008
index of digital X-ray imaging systems -
Part 1: Definitions and requirements for
general radiography
IEC 61223-3-8 ®
Edition 1.0 2024-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50  ISBN 978-2-8322-8565-7

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CONTENTS
FOREWORD . 8
INTRODUCTION . 10
1 Scope and object . 11
2 Normative references . 11
3 Terms, definitions, symbols and abbreviated terms . 12
3.1 Terms and definitions . 12
3.2 Symbols and abbreviated terms . 21
4 General aspects of ACCEPTANCE TESTING . 21
4.1 General . 21
4.2 Levels of requirements . 22
4.2.1 General . 22
4.2.2 Local regulatory requirements . 22
4.2.3 Contractual requirements . 22
4.2.4 MANUFACTURER specifications . 22
4.3 General conditions in test procedures . 22
4.4 Documents and data for the tests . 22
4.5 Test conditions . 23
4.6 Scope of tests . 25
4.7 Test equipment including PHANTOMS and TEST DEVICES . 26
4.7.1 General . 26
4.7.2 Analysis software. 26
4.7.3 Viewing conditions . 26
4.7.4 High-voltage measuring instrument . 26
4.7.5 DOSIMETER . 26
4.7.6 PHANTOMS, TEST DEVICES and their application . 26
4.8 Evaluating the test results . 29
5 Specific aspects of CONSTANCY TESTING . 29
5.1 General . 29
5.2 Establishment of BASELINE VALUES . 29
5.3 CONSTANCY TESTING and SIMPLE CHECKS . 30
5.4 Frequency of CONSTANCY TESTS . 30
6 Summary of tests for X‑RAY EQUIPMENT . 30
7 Requirements and test methods . 32
7.1 General . 32
7.2 Functional properties . 33
7.2.1 Test requirements . 33
7.2.2 Test method for ACCEPTANCE TEST . 33
7.2.3 Test method for CONSTANCY TEST . 33
7.3 IMAGE DISPLAY DEVICE performance . 33
7.3.1 Test requirements . 33
7.3.2 Test method for ACCEPTANCE TEST . 33
7.3.3 Test method for CONSTANCY TEST . 34
7.4 X‑RAY TUBE VOLTAGE . 34
7.4.1 Test requirements . 34
7.4.2 Test method for ACCEPTANCE TEST . 34
7.4.3 Test method for CONSTANCY TEST . 35

IEC 61223-3-8:2024 © IEC 2024 – 3 –
7.5 X‑RAY TUBE CURRENT or CURRENT TIME PRODUCT . 35
7.5.1 Test requirements . 35
7.5.2 Test method for ACCEPTANCE TEST . 35
7.5.3 Test method for CONSTANCY TEST . 35
7.6 HALF-VALUE LAYER of the X‑RAY SOURCE ASSEMBLY . 35
7.6.1 Test requirements . 35
7.6.2 Test method for ACCEPTANCE TEST . 36
7.6.3 Test method for CONSTANCY TEST . 36
7.7 * QUALITY EQUIVALENT FILTRATION of ADDED FILTERS . 36
7.7.1 Test requirements . 36
7.7.2 * Test method for ACCEPTANCE TEST . 36
7.7.3 Test method for CONSTANCY TEST . 36
7.8 * ATTENUATION EQUIVALENT of materials between the PATIENT and the X‑RAY
IMAGE RECEPTOR . 36
7.8.1 Test requirements . 36
7.8.2 * Test method for ACCEPTANCE TEST . 37
7.8.3 Test method for CONSTANCY TEST . 37
7.9 FOCAL SPOT of the X‑RAY TUBE . 37
7.9.1 Test requirements . 37
7.9.2 Test method for ACCEPTANCE TEST . 37
7.9.3 Test method for CONSTANCY TEST . 37
7.10 Assessing geometrical properties of the X-RAY EQUIPMENT . 37
7.10.1 Test requirements . 37
7.10.2 Test method for ACCEPTANCE TEST . 37
7.10.3 Test method for CONSTANCY TEST . 37
7.11 AUTOMATIC CONTROL SYSTEM ─ Performance . 38
7.11.1 Test requirements . 38
7.11.2 * Test method for ACCEPTANCE TEST . 38
7.11.3 * Test method for CONSTANCY TEST . 38
7.12 AUTOMATIC CONTROL SYSTEM ─ Reproducibility . 38
7.12.1 Test requirements . 38
7.12.2 Test method for ACCEPTANCE TEST . 38
7.12.3 Test method for CONSTANCY TEST . 38
7.13 * AUTOMATIC CONTROL SYSTEM – NOMINAL SHORTEST IRRADIATION TIME . 38
7.13.1 Test requirements . 38
7.13.2 * Test method for ACCEPTANCE TEST . 38
7.13.3 Test method for CONSTANCY TEST . 39
7.14 Correspondence between the X‑RAY FIELD and EFFECTIVE IMAGE RECEPTION
AREA . 39
7.14.1 Test requirements . 39
7.14.2 Test method for ACCEPTANCE TEST . 40
7.14.3 Test method for CONSTANCY TEST . 41
7.15 Accuracy of indication of the LIGHT FIELD-INDICATOR . 41
7.15.1 Test requirements . 41
7.15.2 Test method for ACCEPTANCE TEST . 42
7.15.3 Test method for CONSTANCY TEST . 42
7.16 Accuracy of marked and written indications of the X‑RAY FIELD size . 43
7.16.1 Test requirements . 43
7.16.2 Test method for ACCEPTANCE TEST . 43

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7.16.3 Test method for CONSTANCY TEST . 43
7.17 AIR KERMA RATE at the ENTRANCE PLANE of the X‑RAY IMAGE RECEPTOR for
RADIOSCOPY. 43
7.17.1 Test requirements . 43
7.17.2 Test method for ACCEPTANCE TEST . 44
7.17.3 Test method for CONSTANCY TEST . 44
7.18 REFERENCE AIR KERMA RATE for RADIOSCOPY . 44
7.18.1 Test requirements . 44
7.18.2 Test method for ACCEPTANCE TEST . 44
7.18.3 Test method for CONSTANCY TEST . 45
7.19 AIR KERMA at the ENTRANCE PLANE of the X‑RAY IMAGE RECEPTOR for
RADIOGRAPHY . 46
7.19.1 Test requirements . 46
7.19.2 Test method for ACCEPTANCE TEST . 46
7.19.3 Test method for CONSTANCY TEST . 46
7.20 REFERENCE AIR KERMA for SERIAL RADIOGRAPHY . 46
7.20.1 Test requirements . 46
7.20.2 Test method for ACCEPTANCE TEST . 46
7.20.3 Test method for CONSTANCY TEST . 46
7.21 Limitation of the REFERENCE AIR KERMA RATE in RADIOSCOPY . 46
7.21.1 Test requirements . 46
7.21.2 Test method for ACCEPTANCE TEST . 46
7.21.3 Test method for CONSTANCY TEST . 47
7.22 SPATIAL RESOLUTION for RADIOSCOPY and RADIOGRAPHY . 47
7.22.1 Test requirements . 47
7.22.2 Test method for ACCEPTANCE TEST . 47
7.22.3 Test method for CONSTANCY TEST . 49
7.23 LOW CONTRAST RESOLUTION for RADIOSCOPY and RADIOGRAPHY . 49
7.23.1 Test requirements . 49
7.23.2 Test method for ACCEPTANCE TEST . 50
7.23.3 Test method for CONSTANCY TEST . 50
7.24 DYNAMIC RANGE for RADIOSCOPY and RADIOGRAPHY . 50
7.24.1 Test requirements . 50
7.24.2 Test method for ACCEPTANCE TEST . 51
7.24.3 Test method for CONSTANCY TEST . 51
7.25 DOSE AREA PRODUCT and REFERENCE AIR KERMA (RATE) indicator . 51
7.25.1 Test requirements . 51
7.25.2 Test method for ACCEPTANCE TEST . 51
7.25.3 Test method for CONSTANCY TEST . 51
7.26 Back-up timer and safety measures . 51
7.26.1 Test requirements . 51
7.26.2 Test method for ACCEPTANCE TEST . 51
7.26.3 Test method for CONSTANCY TEST . 52
7.27 ARTEFACTS . 52
7.27.1 Test requirements . 52
7.27.2 Test method for ACCEPTANCE TEST . 52
7.27.3 Test method for CONSTANCY TEST . 53
7.28 Accuracy of image measuring functions . 53
7.28.1 Test requirements . 53

IEC 61223-3-8:2024 © IEC 2024 – 5 –
7.28.2 Test method for ACCEPTANCE TEST . 53
7.28.3 Test method for CONSTANCY TEST . 53
7.29 DYNAMIC RANGE for SUBTRACTION IMAGING . 53
7.29.1 Test requirements . 53
7.29.2 Conditions for testing the SUBTRACTION IMAGING mode . 53
7.29.3 Test method for ACCEPTANCE TEST . 53
7.29.4 Test method for CONSTANCY TEST . 54
7.30 Contrast sensitivity for SUBTRACTION IMAGING . 54
7.30.1 Test requirements . 54
7.30.2 Test method for ACCEPTANCE TEST . 54
7.30.3 Test method for CONSTANCY TEST . 54
7.31 SPATIAL RESOLUTION for SUBTRACTION IMAGING . 54
7.31.1 Test requirements . 54
7.31.2 Test method for ACCEPTANCE TEST . 55
7.31.3 Test method for CONSTANCY TEST . 55
7.32 ARTEFACTS in SUBTRACTION IMAGING . 55
7.32.1 Test requirements . 55
7.32.2 Test method for ACCEPTANCE TEST . 55
7.32.3 Test method for CONSTANCY TEST . 55
7.33 X‑RAY IMAGE RECEPTOR EXPOSURE INDEX . 55
7.33.1 Test requirements . 55
7.33.2 Test method for ACCEPTANCE TEST . 56
7.33.3 Test method for CONSTANCY TEST . 56
7.34 LEAKAGE RADIATION in the LOADING STATE . 57
7.34.1 Test requirements . 57
7.34.2 Test method for ACCEPTANCE TEST . 57
7.34.3 Test method for CONSTANCY TEST . 57
Annex A (informative) General guidance and rationale . 58
A.1 Aim and background information . 58
A.2 Medical radiological equipment lifecycle testing . 58
A.2.1 General . 58
A.2.2 The "lifecycle" . 58
A.3 Rationale for particular clauses and subclauses . 61
Annex B (informative) Use of REFERENCE AIR KERMA and AIR KERMA at the ENTRANCE
PLANE of the X‑RAY IMAGE RECEPTOR . 64
B.1 General . 64
B.2 Issues with AIR KERMA at the ENTRANCE PLANE of the X‑RAY IMAGE RECEPTOR
as a measure of performance . 64
B.3 AIR KERMA at the ENTRANCE PLANE of the X‑RAY IMAGE RECEPTOR as an
ACCEPTANCE TEST or CONSTANCY TEST . 64
B.4 REFERENCE AIR KERMA as a measure of performance . 65
B.5 REFERENCE AIR KERMA as an ACCEPTANCE TEST . 65
Annex C (informative) Assessing clinical protocol performance . 66
C.1 General . 66
C.2 Discussion . 66
Annex D (informative) Examples of TEST DEVICES for image quality evaluation . 67
D.1 General . 67
D.2 TEST DEVICE according to DIN 6868-150 . 67
D.3 Leeds X‑ray test objects for RADIOGRAPHY/RADIOSCOPY systems . 67

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D.4 LOW CONTRAST RESOLUTION TEST DEVICE of the University of Alabama at
Birmingham, USA. 67
Annex E (informative) Examples of DSA PHANTOMS . 69
E.1 General . 69
E.2 Generic DSA PHANTOM . 69
E.3 DSA PHANTOM with test step for compensation . 71
Annex F (informative) QUALITY CONTROL in cone beam computed tomography (CBCT) . 73
F.1 General . 73
F.2 Image quality parameters . 73
F.2.1 Summary of tests for CBCT . 73
F.2.2 Uniformity . 73
F.2.3 Geometrical precision . 74
F.2.4 Voxel density values . 75
F.2.5 Noise . 75
F.2.6 LOW CONTRAST RESOLUTION . 75
F.2.7 SPATIAL RESOLUTION . 76
F.3 Tests of RADIATION output . 76
F.3.1 General . 76
F.3.2 Cumulative DOSE AREA PRODUCT . 77
F.3.3 AIR KERMA at the ENTRANCE PLANE of the X‑RAY IMAGE RECEPTOR . 78
F.3.4 In-phantom dosimetry indexes – CTDI metrics . 78
F.3.5 Cumulative AIR KERMA . 79
F.4 Image quality PHANTOMS . 79
Annex G (informative) Guidance for MANUFACTURER supplied QUALITY CONTROL manual. 80
G.1 General . 80
G.2 Generic considerations for a QUALITY CONTROL manual . 80
G.3 Prerequisites for guidance for MANUFACTURER supplied QUALITY CONTROL
manual . 80
G.3.1 General . 80
G.3.2 General aspects . 81
G.3.3 Objective of test . 81
G.3.4 Test methods, test equipment and test objects . 81
G.3.5 Frequency of test . 81
G.3.6 Acceptance and constancy criteria . 81
G.4 Example of a QUALITY CONTROL manual for a DOSE AREA PRODUCT verification . 82
Annex H (informative) Uncertainty aspects of testing on X‑RAY EQUIPMENT for
RADIOGRAPHY and RADIOSCOPY . 84
H.1 General . 84
H.2 Measurements performed in a clinical facility . 85
H.3 Measurements made by placing a probe in the X‑RAY BEAM . 85
H.3.1 General . 85
H.3.2 Direct setting of the X‑ray equipment . 86
H.3.3 Indirect setting of the X‑ray equipment . 86
Annex I (informative) Examples of SIMPLE CHECKS . 87
I.1 General . 87
I.2 Examples of visual inspection . 87
I.3 Examples of indicated values of parameters . 87
Annex J (informative) Examples of system changes and relevant ACCEPTANCE TESTS . 89
Bibliography . 90

IEC 61223-3-8:2024 © IEC 2024 – 7 –
Index of defined terms . 93

Figure 1 – Indicative measuring arrangement for RADIOGRAPHY and RADIOSCOPY
equipment for AIR KERMA measurements. 24
Figure 2 – Indicative measuring arrangement for RADIOGRAPHY and RADIOSCOPY
equipment to test geometry and resolutions . 25
Figure 3 – Example of a LINE PAIR RESOLUTION TEST DEVICE . 28
Figure 4 – MODULATION TRANSFER FUNCTION TEST DEVICE . 28
Figure 5 – Discrepancies in covering the IMAGE RECEPTION AREA . 41
Figure 6 – Discrepancies in visual indication of the X‑RAY FIELD . 42
Figure A.1 – Lifecycle of X‑ray imaging equipment . 59
Figure E.1 – Generic DSA PHANTOM . 70
Figure E.2 – DSA PHANTOM with test step for compensation . 72
Figure F.1 – Position of the ROIs for the calculation of the uniformity . 74
Figure F.2 – CTDI PHANTOM with the positions of the DOSIMETER . 78
Figure G.1 – Measurement set-up for DAP measurement . 82
Figure H.1 – Decision points with respect to MEASUREMENT UNCERTAINTY. 85

Table 1 – QUALITY CONTROL tests and recommended frequencies . 31
Table E.1 – Summary of properties of the generic DSA PHANTOM. . 69
Table E.2 – Summary of properties of the DSA PHANTOM with test step for compensation. 71
Table F.1 – Summary of image quality tests for CBCT including suggested frequencies . 73
Table F.2 – Summary of RADIATION output tests for CBCT including suggested
frequency. . 77
Table J.1 – Overview of relevant ACCEPTANCE TESTS related to system changes . 89

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INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
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

FOREWORD
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IEC 61223-3-8 has been prepared by subcommittee 62B: Medical imaging equipment, software,
and systems, of IEC technical committee 62: Medical equipment, software, and systems. It is
an International Standard.
The text of this document is based on the following documents:
Draft Report on voting
62B/1347/FDIS 62B/1351/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
IEC 61223-3-8:2024 © IEC 2024 – 9 –
The language used for the development of this International Standard is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
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