IEC 61676:2002+AMD1:2008 CSV

IEC 61676 ®
Edition 1.1 2009-01
INTERNATIONAL
STANDARD
Medical electrical equipment – Dosimetric instruments used for non-invasive
measurement of X-ray tube voltage in diagnostic radiology

IEC 61676:2002+A1:2008
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IEC 61676 ®
Edition 1.1 2009-01
INTERNATIONAL
STANDARD
Medical electrical equipment – Dosimetric instruments used for non-invasive
measurement of X-ray tube voltage in diagnostic radiology

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
CL
ICS 11.040.50; 11.040.55 ISBN 978-2-88910-552-6
– 2 – 61676 © IEC:2002+A1:2008(E)
CONTENTS
FOREWORD.3
INTRODUCTION.5

1 Scope and object.6
2 Normative references.6
3 Terminology and definitions.7
4 General performance requirements for measurement of PRACTICAL PEAK VOLTAGE
measurements.10
4.1 Quantity to be measured .10
4.2 Limits of PERFORMANCE CHARACTERISTICs .10
4.3 LIMITS OF VARIATION for effects of INFLUENCE QUANTITIES.13
4.4 Performance test procedures.15
5 Special instrumental requirements and marking.22
5.1 Requirements for the complete instruments.22
5.2 General.22
5.3 Display.22
5.4 Range of measurement .22
5.5 Connectors and cables.22
6 ACCOMPANYING DOCUMENTS.23
6.1 General.23
6.2 Information provided.23
6.3 Instrument description.23
6.4 Detector.23
6.5 Delay time.23
6.6 Measurement window.23
6.7 Data outlet.23
6.8 Transport and storage.23

Annex A (informative) Recommended performance criteria for the invasive divider .24
Annex B (informative) Additional information on PRACTICAL PEAK VOLTAGE .25
Annex C (informative) Glossary of defined terms .32

61676 © IEC:2002+A1:2008 (E) – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
⎯⎯⎯⎯⎯
MEDICAL ELECTRICAL EQUIPMENT –

Dosimetric instruments used for non-invasive measurement
of X-ray tube voltage in diagnostic radiology

FOREWORD
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International Standard IEC 61676 has been prepared by subcommittee SC 62C: Equipment
for radiotherapy, nuclear medicine and radiation dosimetry, of IEC Technical Committee 62:
Electrical equipment in medical practice.
This consolidated version of IEC 61676 consists of the first edition (2002) [documents
62C/340/FDIS and 62C/344/RVD] and its amendment 1 (2008) [documents 62C/445/CDV and
62C/452/RVC].
The technical content is therefore identical to the base edition and its amendment and has
been prepared for user convenience.
It bears the edition number 1.1.
A vertical line in the margin shows where the base publication has been modified by
amendment 1.
NOTE In the amendment, a new influence quantity “Additional tungsten filtration (tube aging)” has been
introduced.
– 4 – 61676 © IEC:2002+A1:2008(E)
Annexes A, B and C are for information only.
In this standard the following print types are used:
− requirements, compliance with which can be tested, and definitions: in roman type;
− notes, explanations, advice, general statements and exceptions: in small roman type;
− test specifications: in italic type;
− TERMS USED THROUGHOUT THIS STANDARD THAT HAVE BEEN DEFINED IN CLAUSE 3 OR IN IEC
60601-1 AND ITS COLLATERAL STANDARDS: IN SMALL CAPITALS.
The committee has decided that the contents of the base publication and its amendments will
remain unchanged until the maintenance result date indicated on the IEC web site under
"http://webstore.iec.ch" in the data related to the specific publication. At this date,
the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
A bilingual version of this publication may be issued at a later date.

NOTE The committee is aware of the fact that this standard does not address all problems associated with non-
invasive high voltage measurements. In particular one influence quantity concerning the target condition is not
dealt with at all. Before this can be done, a substantial amount of measurements is still necessary to improve the
physical understanding of this influence quantity. On the other hand, for the reasons described in the introduction
there is an urgent need to publish this standard in order to assure that non-invasive measurements are comparable
to each other within tolerable uncertainties, regardless of differences in X-RAY GENERATOR, waveform or other
influence quantities (except target condition), which is not the case for the time being. The committee has decided
to revise this standard as soon as sufficient knowledge on the outstanding items is available.

61676 © IEC:2002+A1:2008 (E) – 5 –
INTRODUCTION
The result of a measurement of the X-RAY TUBE VOLTAGE by means of invasive or non-invasive
instruments is normally expressed in the form of one single number for the value of the tube
voltage, irrespective of whether the tube voltage is constant potential or shows a time
dependent waveform. Non-invasive instruments for the measurement of the X-RAY TUBE
VOLTAGE on the market usually indicate the ‘mean peak voltage’. But the quantity ‘mean peak
voltage’ is not unambiguously defined and may be any mean of all voltage peaks. It is
impossible to establish test procedures for the performance requirements of non-invasive
instruments for the measurement of the X-RAY TUBE VOLTAGE without the definition of the
quantity under consideration. Therefore, this Standard is based on a quantity recently
proposed in the literature to be called "PRACTICAL PEAK VOLTAGE". The PRACTICAL PEAK
VOLTAGE is unambiguously defined and applicable to any waveform. This quantity is related to
the spectral distribution of the emitted X-RADIATION and the image properties. X-RAY
GENERATORS operating at the same value of the PRACTICAL PEAK VOLTAGE will produce the
same low level contrast in the RADIOGRAMS, even when the waveforms of the tube voltages
are different. Detailed information on this concept is provided in Annex B. An example for the
calculation of the PRACTICAL PEAK VOLTAGE in the case of a “falling load” waveform is also
given in Annex B.
As a result of introducing a new quantity, the problem arises that this standard has been
written for instruments which were not explicitly designed for the measurement of the
PRACTICAL PEAK VOLTAGE. However, from preliminary results of a trial type test of a non-
invasive instrument currently on the market, it can be expected that future instruments and
most instruments on the market will be able to fulfil the requirements stated in this standard
without insurmountable difficulties. For the most critical requirements on voltage waveform
and frequency dependence of the RESPONSE, it turned out from these investigations that it is
even easier to comply with the standard by using the PRACTICAL PEAK VOLTAGE as the
measurement quantity.
The calibration and adjustment of the X-RAY TUBE VOLTAGE of an X-RAY GENERATOR is generally
performed by the MANUFACTUR
...