EN 61676:2002
(Main)Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
Specifies the performance requirements of instruments as used in the non-invasive measurement of X-ray tube voltage up to 150 kV and the relevant compliance tests. Describes the method for calibration and gives guidance for estimating the uncertainty in measurements performed under conditions different from those during calibration. This standard is not concerned with the safety aspect of such instruments. The requirements for electrical safety applying to them are contained in EN 60601-1.
Medizinische elektrische Geräte - Geräte für die nicht-invasive Messung der Röntgenröhrenspannung in der diagnostischen Radiologie
Appareils électromédicaux - Instruments de dosimétrie pour la mesure non invasive de la tension du tube radiogène dans la radiologie de diagnostic
Medicinska električna oprema - Dozimetrijska oprema za posredno merjenje napetosti rentgenske elektronke v diagnostični radiologiji
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2003
0HGLFLQVNDHOHNWULþQDRSUHPD'R]LPHWULMVNDRSUHPD]DSRVUHGQRPHUMHQMH
QDSHWRVWLUHQWJHQVNHHOHNWURQNHYGLDJQRVWLþQLUDGLRORJLML
Medical electrical equipment - Dosimetric instruments used for non-invasive
measurement of X-ray tube voltage in diagnostic radiology
Medizinische elektrische Geräte - Geräte für die nicht-invasive Messung der
Röntgenröhrenspannung in der diagnostischen Radiologie
Appareils électromédicaux - Instruments de dosimétrie pour la mesure non invasive de la
tension du tube radiogène dans la radiologie de diagnostic
Ta slovenski standard je istoveten z: EN 61676:2002
ICS:
11.040.50 Radiografska oprema Radiographic equipment
17.240 Merjenje sevanja Radiation measurements
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN 61676
NORME EUROPÉENNE
EUROPÄISCHE NORM December 2002
ICS 11.040.50; 11.040.55
English version
Medical electrical equipment -
Dosimetric instruments used for non-invasive measurement
of X-ray tube voltage in diagnostic radiology
(IEC 61676:2002)
Appareils électromédicaux - Medizinische elektrische Geräte –
Instruments de dosimétrie pour la mesure Geräte für die nicht-invasive Messung
non invasive de la tension du tube radiogène der Röntgenröhrenspannung
dans la radiologie de diagnostic in der diagnostischen Radiologie
(CEI 61676:2002) (IEC 61676:2002)
This European Standard was approved by CENELEC on 2002-11-01. 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, Czech Republic,
Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta,
Netherlands, Norway, Portugal, Slovakia, 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
© 2002 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 61676:2002 E
Foreword
The text of document 62C/340/FDIS, future edition 1 of IEC 61676, 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
EN 61676 on 2002-11-01.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2003-08-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2005-11-01
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 annexes A, B and C are informative.
Annex ZA has been added by CENELEC.
In this standard, the following print types are used:
– requirements, compliance with which can be tested, and definitions: roman type;
– notes, explanations, advice, general statements and exceptions: smaller roman type;
– test specifications: italic type;
– TERMS USED THROUGHOUT THIS STANDARD THAT HAVE BEEN DEFINED IN CLAUSE 3 OR IN EN 60601-1:
SMALL CAPITALS.
__________
Endorsement notice
The text of the International Standard IEC 61676:2002 was approved by CENELEC as a European
Standard without any modification.
__________
- 3 - EN 61676:2002
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of any
of these publications apply to this European Standard only when incorporated in it by amendment or
revision. For undated references the latest edition of the publication referred to applies (including
amendments).
NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
Publication Year Title EN/HD Year
IEC 60417 Series Graphical symbols for use on equipment EN 60417 Series
IEC 60788 1984 Medical radiology - Terminology - -
IEC 61000-4-2 1995 Electromagnetic compatibility (EMC) EN 61000-4-2 1995
Part 4-2: Testing and measurement
techniques - Electrostatic discharge
immunity test
IEC 61000-4-3 2002 Part 4-3: Testing and measurement EN 61000-4-3 2002
techniques - Radiated, radio-frequency,
electromagnetic field immunity test
IEC 61000-4-4 1995 Part 4-4: Testing and measurement EN 61000-4-4 1995
techniques - Electrical fast
transient/burst immunity test
IEC 61000-4-5 1995 Part 4-5: Testing and measurement EN 61000-4-5 1995
techniques - Surge immunity test
IEC 61000-4-6 1996 Part 4-6: Testing and measurement EN 61000-4-6 1996
techniques - Immunity to conducted
disturbances, induced by radio-
frequency fields
IEC 61000-4-11 1994 Part 4-11: Testing and measurement EN 61000-4-11 1994
techniques - Voltage dips, short
interruptions and voltage variations
immunity tests
IEC 61010-1 2001 Safety requirements for electrical EN 61010-1 2001
equipment for measurement, control, + corr. June 2002
and laboratory use
Part 1: General requirements
IEC 61187 (mod) 1993 Electrical and electronic measuring EN 61187 1994
equipment - Documentation + corr. March 1995
Publication Year Title EN/HD Year
ISO 1993 International vocabulary of basic and - -
general terms in metrology
ISO 7000 1989 Graphical symbols for use on - -
equipment - Index and synopsis
INTERNATIONAL IEC
STANDARD
First edition
2002-09
Medical electrical equipment –
Dosimetric instruments used for
non-invasive measurement of X-ray
tube voltage in diagnostic radiology
Appareils électromédicaux –
Instruments de dosimétrie pour la mesure
non invasive de la tension du tube radiogène
dans la radiologie de diagnostic
IEC 2002 Copyright - all rights reserved
No part of this publication may be reproduced or utilized in any form or by any means, electronic or
mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: +41 22 919 02 11 Telefax: +41 22 919 03 00 E-mail: inmail@iec.ch Web: www.iec.ch
PRICE CODE
Commission Electrotechnique Internationale
V
International Electrotechnical Commission
Международная Электротехническая Комиссия
For price, see current catalogue
– 2 – 61676 IEC:2002(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 .21
5.1 Requirements for the complete instruments .21
5.2 General .21
5.3 Display .22
5.4 Range of measurement.22
5.5 Connectors and cables .22
6ACCOMPANYING DOCUMENTS .22
6.1 General .22
6.2 Information provided.22
6.3 Instrument description .22
6.4 Detector.22
6.5 Delay time .22
6.6 Measurement window .22
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(E) – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
MEDICAL ELECTRICAL EQUIPMENT –
Dosimetric instruments used for non-invasive measurement
of X-ray tube voltage in diagnostic radiology
FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of the IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, the IEC publishes International Standards. Their preparation is
entrusted to technical committees; any IEC National Committee interested in the subject dealt with may
participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. The IEC collaborates closely with the International
Organization for Standardization (ISO) in accordance with conditions determined by agreement between the
two organizations.
2) The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, an
international consensus of opinion on the relevant subjects since each technical committee has representation
from all interested National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical specifications, technical reports or guides and they are accepted by the National
Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
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.
The text of this standard is based on the following documents:
FDIS Report on voting
62C/340/FDIS 62C/344/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 3.
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.
– 4 – 61676 IEC:
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