EN 61676:2002

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

• Status: Published
• Publication Date: 16-Dec-2002
• Withdrawal Date: 31-Oct-2005
• ICS: 11.040.50 - Radiographic equipment
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62C - IEC_SC_62C
• Parallel Committee: IEC/SC 62C - IEC_SC_62C
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 17-Dec-2002
• Completion Date: 17-Dec-2002
• Directive: 2004/108/EC - Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC
• Directive: 2004/108/EU - DIRECTIVE 2004/108/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC
• Directive: 2014/30/EU - Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (recast)
• Directive: 89/336/EEC - Electromagnetic compatibility (EMC)
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN 61676:2003 - Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology

Relations

• Replaced By: EN IEC 61676:2023 - Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
• Effective Date: 24-Nov-2020
• Amended By: EN 61676:2002/A1:2009 - Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 61676:2003
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
SIST EN 61676:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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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

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EN 61676:2002 - 2 -
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.
__________

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- 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
...