EN IEC 61010-2-091:2021

Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-091: Particular requirements for cabinet X-ray systems

IEC 61010-2-091:2019 is available as IEC 61010-2-091:2019 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition. IEC 61010-2-091:2019 specifies particular safety requirements for cabinet X-ray systems, which fall under any of categories a), b) or c) below. a) Electrical test and measurement equipment This is equipment which by electromagnetic means tests, measures, indicates or records one or more electrical or physical quantities, also non-measuring equipment such as signal generators, measurement standards, power supplies for laboratory use, transducers, transmitters, etc. NOTE 1 This includes bench-top power supplies intended to aid a testing or measuring operation on another piece of equipment. Power supplies intended to power equipment are within the scope of IEC 61558 (see 1.1.2 h)). This standard also applies to test equipment integrated into manufacturing processes and intended for testing manufactured devices. NOTE 2 Manufacturing test equipment is likely to be installed adjacent to and interconnected with industrial machinery in this application. b) Electrical industrial process-control equipment This is equipment which controls one or more output quantities to specific values, with each value determined by manual setting, by local or remote programming, or by one or more input variables. c) Electrical laboratory equipment This is equipment which measures, indicates, monitors, inspects or analyses materials, or is used to prepare materials, and includes in vitro diagnostic (IVD) equipment. This equipment may also be used in areas other than laboratories; examples include selftest IVD equipment to be used in the home and inspection equipment to be used to check people or material during transportation. This second edition cancels and replaces the first edition published in 2012. It constitutes a technical revision. This edition includes the following significant changes from the first edition, as well as numerous other changes: - The scope of the document has been clarified and limited to equipment up to 500 kV. - Additional marking requirements for X-ray generating assemblies have been added. (5.1) - Requirements for high-voltage cables used in the X-ray assembly have been added. (6.5) - Insulation requirements have been added. (6.7) - Temperature requirements for beam-limiting devices have been added. (10.3) - Clarification has been provided on and , and test methods. (12) - Requirements for have been modified, taking into account functional safety standards. (15) - Requirements for reasonably foreseeable misuse have been clarified. (16) - Risk assessment has been made mandatory for specific aspects. (17)

Sicherheitsbestimmungen für elektrische Mess-, Steuer-, Regel- und Laborgeräte - Teil 2-091: Besondere Anforderungen für Röntgengeräteschränke

Règles de sécurité pour appareils électriques de mesurage, de régulation et de laboratoire - Partie 2-091: Exigences particulières pour les équipements à rayons X montés en armoire

IEC 61010-2-091:2019 est disponible sous forme de IEC 61010-2-091:2019 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente. L'IEC 61010-2-091:2019 spécifie les exigences de sécurité particulières pour les équipements à rayons X montés en armoire, qui relèvent de n'importe laquelle des catégories de 1.1.1 a), b) ou c). a) Appareils électriques d'essai et de mesurage Il s'agit d'appareils qui, par des moyens d'ordre électromagnétique, mesurent, indiquent ou enregistrent une ou plusieurs grandeurs électriques ou physiques, ainsi que des appareils non-mesureurs tels que générateurs de signaux, étalons de mesure, alimentations de puissance de laboratoire, transducteurs, transmetteurs, etc. NOTE 1 Cela comprend les alimentations de puissance de table prévues pour permettre des opérations de test ou de mesure sur une autre partie d'appareil. Les alimentations de puissance destinées à alimenter les appareils de puissance sont dans le champ d'application de l’IEC 61558 (voir 1.1.2 h)). Cette norme s'applique aussi aux équipements de test intégrés dans les lignes de fabrication et prévus pour tester les appareils en cours de fabrication. NOTE 2 De tels équipements de tests peuvent être attenants et connectés à des machines industrielles dans cette application. b) Appareils électriques de contrôle de procédés industriels Il s'agit d'appareils qui règlent une ou plusieurs grandeurs de sortie selon des valeurs spécifiques, chaque valeur étant déterminée par réglage manuel, par programmation locale ou à distance, ou par une ou plusieurs variables d'entrée. c) Appareils électriques de laboratoire Il s'agit d'appareils qui mesurent, indiquent, surveillent, inspectent ou analysent des matériaux, ou qui servent à préparer des matériaux, y compris les appareils de diagnostic in vitro (DIV). Ces appareils peuvent également être utilisés ailleurs que dans des laboratoires; par exemple les appareils DIV d’autotest personnel utilisés à domicile et les appareils d’inspection utilisés pour contrôler les personnes ou les objets pendant le transport. Cette deuxième édition annule et remplace la première édition parue en 2012. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à la première édition, ainsi que de nombreuses autres modifications. - Le domaine d'application du document a été clarifié et limité aux appareils inférieurs à 500 kV. - Des exigences supplémentaires de marquage pour les ensembles générant des rayons X ont été ajoutées. (5.1) - Des exigences relatives aux câbles à haute tension utilisés dans l'ensemble radiogène ont été ajoutées. (6.5) - Des exigences relatives à l'isolation ont été ajoutées. (6.7) - Des exigences relatives à la température pour les ont été ajoutées. (10.3) - Une clarification a été ajoutée concernant les et , et des méthodes d'essai. (12) - Les exigences relatives aux ont été modifiées, prenant ainsi en compte les normes de sécurité fonctionnelle. (15) - Les exigences relatives au mauvais usage raisonnablement prévisible ont été clarifiées. (16) - L'appréciation du risque a été rendue obligatoire pour des aspects spécifiques. (17)

Varnostne zahteve za električno opremo za meritve, nadzor in laboratorijsko uporabo - 2-091. del: Posebne zahteve za rentgenske sisteme v ohišjih (IEC 61010-2-091:2019)

General Information

• Status: Published
• Publication Date: 29-Apr-2021
• ICS: 19.080 - Electrical and electronic testing
• ICS: 71.040.10 - Chemical laboratories. Laboratory equipment
• Technical Committee: CLC/TC 66X - Safety of measuring, control, and laboratory equipment
• Drafting Committee: IEC/TC 66 - IEC_TC_66
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 30-Apr-2021
• Completion Date: 30-Apr-2021
• Directive: 2014/35/EU - Directive 2014/35/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 the making available on the market of electrical equipment designed for use within certain voltage limits
• Mandate: M/511 - Mandate to CEN, CENELEC and ETSI relating to harmonised standards in the field of the Low Voltage Directive
• Ref Project: SIST EN IEC 61010-2-091:2021 - Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-091: Particular requirements for cabinet X-ray systems (IEC 61010-2-091:2019)

Relations

• Replaces: EN 61010-2-091:2012 - Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-091: Particular requirements for cabinet X-ray systems
• Effective Date: 04-May-2021
• Replaces: EN 61010-2-091:2012/AC:2013 - Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-091: Particular requirements for cabinet X-ray systems
• Effective Date: 04-May-2021
• Amended By: EN IEC 61010-2-091:2021/A11:2021 - Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-091: Particular requirements for cabinet X-ray systems
• Effective Date: 24-Dec-2019

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2021
Nadomešča:
SIST EN 61010-2-091:2012
SIST EN 61010-2-091:2012/AC:2013
Varnostne zahteve za električno opremo za meritve, nadzor in laboratorijsko
uporabo - 2-091. del: Posebne zahteve za rentgenske sisteme v ohišjih (IEC 61010-
2-091:2019)
Safety requirements for electrical equipment for measurement, control and laboratory
use - Part 2-091: Particular requirements for cabinet X-ray systems (IEC 61010-2-
091:2019)
Sicherheitsbestimmungen für elektrische Mess-, Steuer-, Regel- und Laborgeräte - Teil 2
-091: Besondere Anforderungen für Röntgengeräteschränke (IEC 61010-2-091:2019)
Règles de sécurité pour appareils électriques de mesurage, de régulation et de
laboratoire - Partie 2-091: Exigences particulières pour les équipements à rayons X
montés en armoire (IEC 61010-2-091:2019)
Ta slovenski standard je istoveten z: EN IEC 61010-2-091:2021
ICS:
19.080 Električno in elektronsko Electrical and electronic
preskušanje testing
71.040.10 Kemijski laboratoriji. Chemical laboratories.
Laboratorijska oprema Laboratory equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 61010-2-091

NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2021
ICS 19.080; 71.040.10 Supersedes EN 61010-2-091:2012 and all of its
amendments and corrigenda (if any)
English Version
Safety requirements for electrical equipment for measurement,
control and laboratory use - Part 2-091: Particular requirements
for cabinet X-ray systems
(IEC 61010-2-091:2019)
Règles de sécurité pour appareils électriques de mesurage, Sicherheitsbestimmungen für elektrische Mess-, Steuer-,
de régulation et de laboratoire - Partie 2-091: Exigences Regel- und Laborgeräte - Teil 2-091: Besondere
particulières pour les équipements à rayons X montés en Anforderungen für Röntgengeräteschränke
armoire (IEC 61010-2-091:2019)
(IEC 61010-2-091:2019)
This European Standard was approved by CENELEC on 2019-03-22. 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,
Turkey 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
© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 61010-2-091:2021 E

European foreword
The text of document 66/684/FDIS, future edition 2 of IEC 61010-2-091, prepared by IEC/TC 66
"Safety of measuring, control and laboratory equipment" was submitted to the IEC-CENELEC parallel
vote and approved by CENELEC as EN IEC 61010-2-091:2021.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2022-04-01
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2024-04-01
document have to be withdrawn
This document supersedes EN 61010-2-091:2012 and all of its amendments and corrigenda (if any).
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.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive(s) see informative Annex ZZ, which is an integral part of
Endorsement notice
The text of the International Standard IEC 61010-2-091:2019 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 standards
indicated:
IEC 60601-1-3 NOTE Harmonized as EN 60601-1-3
IEC 60846-1 NOTE Harmonized as EN 60846-1
IEC 61508 (series) NOTE Harmonized as EN 61508 (series)
IEC 62304 NOTE Harmonized as EN 62304
ISO 12100 NOTE Harmonized as EN ISO 12100
ISO 13849 (series) NOTE Harmonized as EN ISO 13849 (series)
ISO 13849-2 NOTE Harmonized as EN ISO 13849-2

IEC 61010-2-091 ®
Edition 2.0 2019-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Safety requirements for electrical equipment for measurement, control, and

laboratory use –
Part 2-091: Particular requirements for cabinet X-ray systems

Règles de sécurité pour appareils électriques de mesurage, de régulation et de

laboratoire –
Partie 2-091: Exigences particulières pour les équipements à rayons X montés

en armoire
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 19.080; 71.040.10 ISBN 978-2-8322-6518-5

– 2 – IEC 61010-2-091:2019  IEC 2019
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
1 Scope and object . 7
2 Normative references . 8
3 Terms and definitions . 8
4 Tests . 9
5 Marking and documentation . 10
6 Protection against electric shock . 13
7 Protection against mechanical HAZARDS . 15
8 Resistance to mechanical stresses . 16
9 Protection against the spread of fire . 16
10 Equipment temperature limits and resistance to heat . 16
11 Protection against HAZARDS from fluids and solid foreign objects . 16
12 Protection against radiation, including laser sources, and against sonic and
ultrasonic pressure . 16
13 Protection against liberated gases and substances, explosion and implosion . 19
14 Components and subassemblies . 19
15 Protection by INTERLOCKS . 20
16 HAZARDS resulting from application . 22
17 RISK assessment . 22
Annexes . 23
Annex L (informative) Index of defined terms . 24
Annex AA (normative) Standard phantom for PARTIALLY PROTECTED EQUIPMENT . 25
Annex BB (informative) Dose limit recommendation for occupational radiation . 26
Bibliography . 27

Figure AA.1 – Phantom for measurement of PARTIALLY PROTECTED EQUIPMENT . 25

Table 101 – Durations of high voltage strength test . 14
Table BB.1 – Dose limits . 26

IEC 61010-2-091:2019  IEC 2019 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT
FOR MEASUREMENT, CONTROL, AND LABORATORY USE –

Part 2-091: Particular requirements for cabinet X-ray systems

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of 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, IEC publishes International Standards, Technical Specifications, Technical Reports,
Publicly Available Specifications (PAS) and Guides (hereafter referred to as "IEC Publication(s)"). 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. 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 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 IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence between
any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses
arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent
rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 61010-2-091 has been prepared by IEC technical committee 66:
Safety of measuring, control and laboratory equipment.
This second edition cancels and replaces the first edition published in 2012. It constitutes a
technical revision.
This edition includes the following significant changes from the first edition, as well as numerous
other changes:
• The scope of the document has been clarified and limited to equipment up to 500 kV.
• Additional marking requirements for X-ray generating assemblies have been added. (5.1)
• Requirements for high-voltage cables used in the X-ray assembly have been added. (6.5)
• Insulation requirements have been added. (6.7)
• Temperature requirements for beam-limiting devices have been added. (10.3)

– 4 – IEC 61010-2-091:2019  IEC 2019
• Clarification has been provided on PROTECTED EQUIPMENT and PARTIALLY PROTECTED
EQUIPMENT, and test methods. (12)
• Requirements for INTERLOCKS have been modified, taking into acco
...