SIST EN IEC 61010-2-091:2021

SLOVENSKI STANDARD
SIST EN IEC 61010-2-091:2021
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
SIST EN IEC 61010-2-091:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 61010-2-091:2021

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SIST EN IEC 61010-2-091:2021


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

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SIST EN IEC 61010-2-091:2021
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
EN IEC 61010-2-091:2021/A11:2021.
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


2

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SIST EN IEC 61010-2-091:2021



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




Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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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

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SIST EN IEC 61010-2-091:2021
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)

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• Clarification has been provided on PROTECTED EQUIPMENT and PARTIALLY PROTECTED
EQUIPMENT, and test methods. (12)
• Requirements for INTERLOCKS 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)
The text of this International Standard is based on the following documents:
FDIS Report on voting
66/684/FDIS 66/686A/RVD

Full information on the voting for the approval of this International Standard can be found in the
report on voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
This document is intended to be used in conjunction with IEC 61010-1. It was established on the
basis of the third edition (2010) of IEC 61010-1, including its Amendment 1 (2016), hereinafter
referred to as Part 1.
This Part 2-091 supplements or modifies the corresponding clauses in IEC 61010-1 so as to
convert that publication into the IEC standard: Particular requirements for cabinet X-ray
systems.
Clauses of Part 1 that are fully applicable are indicated by the statement "This clause of Part 1
is applicable." Where this Part 2-091 identifies a particular subclause and states "addition",
"modification", "replacement", or "deletion", the text of that particular subclause Part 1 is
adapted accordingly. Where a particular subclause of Part 1 is not mentioned in this Part 2-091,
that subclause applies as far as is reasonable.
In this standard:
a) the following print types are used:
– requirements: in roman type;
– NOTES: in small roman type;
– conformity and tests: in italic type;
– terms used throughout this standard which have been defined in Clause 3: SMALL ROMAN
CAPITALS.
b) subclauses, figures, and tables which are additional to those in Part 1 are numbered starting
from 101. Additional annexes are lettered starting from AA and additional list items are
lettered from aa).
A list of all parts of the IEC 61010 series, published under the general title Safety requirements
for electrical equipment for measurement, control, and laboratory use, can be found on the IEC
website.

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SIST EN IEC 61010-2-091:2021
IEC 61010-2-091:2019  IEC 2019 – 5 –
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

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INTRODUCTION
IEC 61010-1 specifies the safety requirements that are generally applicable to all equipment
within its scope. For certain types of equipment, the requirements of IEC 61010-1 and its
amendments will be supplemented or modified by the special requirements of one, or more
than one, particular Part 2s of the standard, which are to be read in conjunction with the Part 1
requirements.
This document has been prepared, based on IEC 61010-1:2010 including its
Amendment 1:2016, to specify additional safety requirements for cabinet X-ray systems. It
provides additional guidance for construction and assessment of extra high voltage circuits,
mechanical HAZARDS and ionizing radiation HAZARDS which can be present in this type of
equipment.
This document has been written to provide protection against both radiation HAZARDS from the
direct X-ray beam and any scattered X-radiation caused by reflections of the X-ray beam on
any part of the equipment or on the sample subjected to X-rays.
The minimum safety requirements specified in this document are considered to provide for a
practical degree of safety in the operation of cabinet X-ray systems.

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SIST EN IEC 61010-2-091:2021
IEC 61010-2-091:2019  IEC 2019 – 7 –
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT
FOR MEASUREMENT, CONTROL, AND LABORATORY USE –

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



1 Scope and object
This clause of Part 1 is applicable, except as follows:
1.1 Scope
1.1.1 Equipment included in scope
Deletion:
Delete the first paragraph.
Replacement:
Replace the second paragraph (above items a) to c)) with the following new text:
This part of IEC 61010 specifies particular safety requirements for cabinet X-ray systems, which
fall under any of categories a), b) or c) below.
Addition:
Add the two following new paragraphs at the end of the subclause:
Equipment covered by this document can be both PROTECTED EQUIPMENT or PARTIALLY
PROTECTED EQUIPMENT, with X-ray generator voltage up to 500 kV.
A cabinet X-ray system is a system that contains an X-ray tube installed in a cabinet, which,
independently of existing architectural structures except the floor on which it may be placed, is
intended to contain at least that portion of a material being irradiated, provide radiation
attenuation and prevent operator access to the radiation beam, during generation of X-radiation.
These cabinet X-ray systems are used in industrial, commercial, and public environments, for
example, to inspect materials, to analyse materials, and to screen baggage.
1.1.2 Equipment excluded from scope
Addition:
Add the following new items to the list:
aa) Equipment intended to apply X-radiation to humans or animals;
bb) Equipment incorporating an X-ray tube but not incorporating complete shielding against
X-radiation HAZARDS, such as:
– equipment intended to be used within a shielded room which excludes personnel during
operation;
– equipment intended to be used with separate portable or temporary shielding;
– equipment intended to produce an emerging beam of X-radiation.

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1.2 Object
1.2.1 Aspects included in scope
Addition:
Add the following new text to the end of the first paragraph:
This part of IEC 61010 specifies requirements for the design and methods of construction of
cabinet X-ray systems to provide adequate protection for OPERATORS, bystanders, trained
service personnel and the surrounding area against unintentionally-emitted X-radiation and from
mechanical HAZARDS related to their conveyors.
2 Normative references
This clause of Part 1 is applicable, except as follows:
Addition:
Add the following references to the list:
IEC 62061, Safety of machinery – Functional safety of safety-related electrical, electronic and
programmable electronic control systems
ISO 13849-1, Safety of machinery – Safety-related parts of control systems – Part 1: General
principles for design
3 Terms and definitions
This clause of Part 1 is applicable, except as follows:
3.2 Parts and accessories
Addition:
Add the following new terms and definitions:
3.2.101
ACCESS PANEL
PROTECTIVE BARRIER or panel which is designed to be removed or opened through the use of a
TOOL for maintenance or service purposes to permit access to the interior of the cabinet
3.2.102
APERTURE
opening in the outside surface of the cabinet, other than a PORT, which remains open during
generation of X-radiation
3.2.103
DOOR
PROTECTIVE BARRIER which is designed to be movable or opened for routine operation purposes,
does not generally require TOOLS to open and permits access to the interior of the cabinet
Note 1 to entry: Inflexible hardware rigidly affixed to the DOOR is considered part of the DOOR.
Note 2 to entry: Access openings intended for the OPERATOR, for removal or re-alignment of samples, are considered
as a DOOR.

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IEC 61010-2-091:2019  IEC 2019 – 9 –
3.2.104
EXTERNAL SURFACE
outside surface of the cabinet X-ray system, including DOORS, ACCESS PANELS, latches, control
knobs and other permanently mounted hardware, the virtual surface across any APERTURE or
PORT, and the bottom of the cabinet
3.2.105
PORT
opening in the EXTERNAL SURFACE of the cabinet which is designed to remain open during
generation of X-rays, for the purpose of conveying objects into and out of the cabinet or for
partial insertion for irradiation of an object with dimensions that do not permit complete insertion
into the cabinet
3.2.106
PROTECTED EQUIPMENT
cabinet X-ray system without any APERTURE or PORT, which would allow access to any area with
X-radiation
Note 1 to entry: Access can be prevented through INTERLOCK protected DOORS, PORTS, APERTURES or ACCESS
PANELS.
3.2.107
PARTIALLY PROTECTED EQUIPMENT
cabinet X-ray system with APERTURE or PORT, allowing access to any area with X-radiation
Note 1 to entry: Access to the X-ray beam or scattered X-radiation could be prevented through a combination of
ENCLOSURE and flexible radiation absorbents, for example, one or several curtains containing lead or another radiation
absorbing material.
3.2.108
BEAM-LIMITING DEVICE
device to limit the radiation field, such as a collimator, a cone or an APERTURE, intended to
restrict the dimensions of X-ray field
3.2.109
INTERLOCK
arrangement of components or devices operating together, intended to prevent a HAZARD or
specific operation whenever safety is compromised by access to the interior of the system,
operational irregularity or equipment failure
[SOURCE: IEC 62463:2010, 3.11, modified – The term "safety interlocks" has been replaced
with "interlock" and the wording "interrupt the generation of X-radiation" has been replaced with
HAZARD or specific operation".]
"a
4 Tests
This clause of Part 1 is applicable, except as follows:
4.3.2.4 Covers and removable parts
Addition:
Add the following new paragraph at the end of the subclause:
For the test in 12.2.1.101.3, any flexible radiation absorbents used to close the APERTURE or
PORT openings for PARTIALLY PROTECTED EQUIPMENT shall remain in their normal closed position.

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5 Marking and documentation
This clause of Part 1 is applicable, except as follows:
5.1 Marking
5.1.3 MAINS supply
Addition:
Add the following new text to item c, after the existing paragraph:
The measured power or input current is not to include a periodic short-time (less than 1 min)
load that is greater than the average 1 min RMS load. However, when such a value exceeds
125 % of the marked nameplate RATING, it shall be included in the marked RATING of the
equipment.
NOTE Transients and initial inrush current are excluded.
Addition:
Add the following new subclause:
5.1.101 Additional markings for cabinet X-ray systems
5.1.101.1 General
The following markings a) to d) shall be provided for cabinet X-ray systems:
a) The equipment shall be marked at the location of each control which may be used to initiate
X-radiation, with the text:
"Caution: X-rays generated when activated"
or substantially similar text or adequate symbol;
b) Equipment where the radiation dose is more than 5 µSv/h shall be marked adjacent to each
PORT or APERTURE, which is sufficiently large to admit human body parts to the interior of the
cabinet, with the text:
"Caution: X-ray hazard. Do not place any
part of the body inside the cabinet when system is activated"
or substantially similar text or adequate symbol.
c) The indicators required by 12.2.1.104 shall be marked "X-ray on", or equivalent text or
symbol;
NOTE If a milliamperemeter is used as one of the required indicators, it is marked as specified in 12.101.4, and
is not marked "X-ray on".
d) For cabinet X-ray systems designed so that humans may enter the cabinet for specified
purposes, permanent markings shall be provided inside the cabinet to describe the function
of the signals and controls required by 12.2.1.104 c) and 12.2.1.104 d).
NOTE Specific purposes can be, but are not limited to, service, maintenance or adjustment of settings.
Conformity is checked by inspection.
Suitable symbols or a combination of symbol and text can be used if evaluation per Clauses 16
and 17 has been performed and the symbols are properly explained in the user documentation.
NOTE National regulations can require a nationally accepted language for safety instructions and symbols.

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5.1.101.2 BEAM-LIMITING DEVICES
BEAM-LIMITING DEVICES detachable in NORMAL USE by an OPERATOR shall be provided with the
following markings:
– those required in IEC 61010-1:2010 and IEC 61010-1:2010/AMD1:2016, 5.1;
– serial designation or individual identification;
– total filtration in terms of quality equivalent filtration.
Conformity is checked by inspection.
5.1.101.3 X-ray tubes
When an X-ray tube is constructed as a component of the cabinet X-ray system, the following is
applicable. The markings on the X-ray tube shall remain readable when the X-ray tube is
dismantled from the X-ray tube housing. The markings shall enable individual products, series or
types to be correlated with their accompanying documents.
X-ray tubes shall be provided with the following markings:
– name or trademark of the manufacturer;
– model or type reference;
– individual identification.
The above markings may be given in the form of a combined designation explained in the
accompanying documents.
Conformity is checked by inspection.
The requirements for X-ray tube assemblies apply when the X-ray tube is part of a subassembly
and not a stand-alone component.
5.1.101.4 X-ray tube assemblies
When X-ray tube assemblies are constructed as components of the cabinet X-ray system, the
following is applicable:
– X-ray tube assemblies shall be provided with the following markings on the outside:
• name or trademark of the manufacturer;
• model or type reference;
• individual identification;
• nominal X-ray tube voltage for which the X-ray tube assembly is designed;
– and, as applicable, the following additional markings:
• indication of the polarity of the receptacles for high-voltage cables;
• permanent filtration.
Conformity is checked by inspection.
5.4 Documentation
5.4.1 General
Replacement:

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Replace item d) with the following new text:
d) the information specified in 5.4.2 to 5.4.6 and in 5.4.101;
5.4.3 Equipment installation
Addition:
Add the following new item:
aa) If cooling is necessary for the safe operation of equipment, or a subassembly thereof, the
cooling requirements shall be indicated in the documents, as identified in the RISK
assessment.
5.4.4 Equipment operation
Addition:
Add the followi
...