IEC 61010-2-091:2019
(Main)Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-091: Particular requirements for cabinet X-ray systems
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 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)
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
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)
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IEC 61010-2-091 ®
Edition 2.0 2019-02
REDLINE VERSION
INTERNATIONAL
STANDARD
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Safety requirements for electrical equipment for measurement, control, and
laboratory use –
Part 2-091: Particular requirements for cabinet X-ray systems
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IEC 61010-2-091 ®
Edition 2.0 2019-02
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Safety requirements for electrical equipment for measurement, control, and
laboratory use –
Part 2-091: Particular requirements for cabinet X-ray systems
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 19.080; 71.040.10 ISBN 978-2-8322-6586-4
– 2 – IEC 61010-2-091:2019 RLV IEC 2019
CONTENTS
FOREWORD . 3
INTRODUCTION . 2
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 . 16
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 . 17
12 Protection against radiation, including laser sources, and against sonic and
ultrasonic pressure . 17
13 Protection against liberated gases and substances, explosion and implosion . 20
14 Components and subassemblies . 20
15 Protection by INTERLOCKS . 21
16 HAZARDS resulting from application . 22
17 RISK assessment . 24
Annexes . 25
Annex L (informative) Index of defined terms . 26
Annex AA (normative) Standard phantom for PARTIALLY PROTECTED EQUIPMENT . 27
Annex BB (informative) Dose limit recommendation for occupational radiation . 28
Bibliography . 29
Figure AA.1 – Phantom for measurement of PARTIALLY PROTECTED EQUIPMENT . 27
Table 101 – Durations of high voltage strength test . 15
Table BB.1 – Dose limits . 28
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
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This redline version of the official IEC Standard allows the user to identify the changes
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– 4 – IEC 61010-2-091:2019 RLV IEC 2019
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)
• 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.
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.
IMPORTANT – The “colour inside” logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct understanding
of its contents. Users should therefore print this publication using a colour printer.
– 6 – IEC 61010-2-091:2019 RLV IEC 2019
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.
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 exclude personnel from the interior 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;
– 8 – IEC 61010-2-091:2019 RLV IEC 2019
– equipment intended to produce an emerging beam of X-radiation.
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.
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 a dimensions that does 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
"a HAZARD or specific operation".]
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.
– 10 – IEC 61010-2-091:2019 RLV IEC 2019
5 Marking and documentation
This clause of Part 1 is applicable, except as follows:
5.1 Marking
Replacement:
Replace the title with:
5.1 Marking, indicators, and annunciators
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 subclauses:
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-ray generation 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 direct X-ray
beam interior of the cabinet, with the text:
"Caution: X-ray hazard. Do not insert 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 5.1.102 12.2.1.104 shall be marked "X-ray on", or equivalent text
or symbol;
NOTE 1 If a milliammeter milliamperemeter is used as one of the required indicators, it is marked as specified
in 5.1.102 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 5.1.102 12.2.1.104 c) and 5.1.102 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 2 National regulations may can require a nationally accepted language for safety instructions and symbols.
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.
– 12 – IEC 61010-2-091:2019 RLV IEC 2019
5.1.102 Indicators and annunciators for CABINET X-RAY SYSTEMS
The equipment shall include all of the following indicators and annunciators.
a) Two independent means to indicate when X-rays are being generated, located so that at
least one indicator is discernible from any location at which the initiation of X-ray
generation is possible. The indicators shall be activated only when X-rays are being
generated, except that if the X-ray generation period is less than 0,5 s, then the indicator
shall be activated for at least 0,5 s. No SINGLE FAULT CONDITION shall disable both
indicators. A combination of software, hardware and digital control may be used to
generate two redundant “X-ray on” signals.
One, but not both, of these indicators may be a milliammeter labeled to indicate X-ray
tube current.
b) Additional indicators shall be provided as needed to ensure that at least one indicator is
visible from each DOOR, ACCESS PANEL, and PORT.
c) For CABINET X-RAY SYSTEMS which are designed so that humans may enter the cabinet for
specified purposes, audible and visual warning signals within the cabinet shall be
provided. These signals shall be activated for at least 10 s immediately prior to the first
initiation of X-ray generation after closing a DOOR designed so that humans may enter
the cabinet. No SINGLE FAULT CONDITION shall disable the audible and the visual
indicators at the same time.
d) For CABINET X-RAY SYSTEMS which are designed so that humans may enter the cabinet for
specified purposes, a visible warning signal shall be provided within the cabinet. The
indicator shall be activated only when X-rays are being generated, except that, if the
X-ray generation period is less than 0,5 s, then the indicator shall be activated for at
least 0,5 s.
Conformity is checked by inspection.
5.4 Documentation
5.4.1 General
Replacement:
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 following new items:
aa) in the instructions for use, the loading factors shall be stated as described below. The
following combinations and data shall be stated:
– the corresponding nominal X-ray tube voltage together with the highest X-ray tube
current obtainable from the equipment when operated at that X-ray tube voltage;
– the corresponding highest X-ray tube current together with the highest X-ray tube voltage
obtainable from the equipment when operating at that X-ray tube current;
– the corresponding combination of X-ray tube voltage and X-ray tube current which results
in the highest electric power in the high-voltage circuit.
The nominal electric power shall be given together with the combination of X-ray tube
voltage and X-ray tube current and, if applicable, the loading time.
The range of acceptable X-ray tube current, X-ray tube voltage and load times may be given
as a table or a curve showing the dependences.
bb) the instructions for use shall state the maximum symmetrical radiation field of the integrated
X-ray source assembly;
cc) the instructions for use shall contain a description of the particular handling and
maintenance of any X-ray image receptor.
Replacement:
Replace the conformity statement with:
Compliance is checked by inspection of the instructions for use.
Addition:
Add the following new subclause:
5.4.101 Additional documentation for cabinet X-ray systems
Instructions for the RESPONSIBLE BODY shall include:
RATINGS of the X-ray generation equipment;
a) voltage, current, and, if applicable, duty cycle
b) instructions concerning radiological safety procedures and precautions which may be
necessary because of unique features of the equipment;
c) a schedule of maintenance necessary to keep the equipment in compliance with this
standard; and
d) a recommendation to consult national authorities to determine any local operational
requirements.
Instructions for service personnel shall include instructions for test after repair or modification to
assure that the equipment remains in compliance with this standard:
e) instructions for test after repair or maintenance.
Instructions for installation and commissioning shall also include instructions for assembly,
adjustment and tests to ensure that the equipment is safe after it is commissioned. See
also 12.101.2.
Conformity is checked by inspection.
6 Protection against electric shock
This clause of Part 1 is applicable, except as follows:
6.5.2 PROTECTIVE BONDING
Addition:
Add the following new subclause:
– 14 – IEC 61010-2-091:2019 RLV IEC 2019
6.5.2.101 X-ray tube assembly
There shall be electrical continuity between the screen of a fitted high-voltage cable and the
ACCESSIBLE metal parts of its receptacle on the X-ray tube assembly.
In addition, high voltage cables, carrying X-ray tube current, ACCESSIBLE by operator or service
personnel, shall incorporate a flexible conductive screen having a maximum resistance per unit
length of 1 Ω/m covered with a non-conductive material capable of protecting the screen against
mechanical damage in NORMAL USE.
Such screens shall be connected to the conductive ENCLOSURE of the high voltage generator and
to that of the x-ray tube assembly.
An exception to this requirement are high voltage cables carrying x-ray tube current within a fully
enclosed and fully integrated X-ray generator / X-ray tube assembly referred to as a monoblock.
Compliance is checked by visual inspection and by measurement.
Flexible conductive screens shall not be recognized as satisfying a requirement for a protective
earth connection between the devices connected by the cable.
6.7 Insulation requirements
6.7.1.5 Requirements for insulation according to type of circuit
Addition:
Add the following new paragraph at the end of the subclause:
Isolation between high voltage circuits in the generator, wiring or X-ray tube and the ACCESSIBLE
circuit is to be based on the actual WORKING VOLTAGE stressing the said isolation.
Isolation requirements for any stator and stator circuit used for the operation of any rotating
anode of the X-ray tube is to be referred to the voltage existing after reduction of the stator
supply voltage to its steady state operating value.
6.7.3 Insulation for secondary circuits derived from MAINS CIRCUITS of OVERVOLTAGE
CATEGORY II up to 300 V
6.7.3.1 General
Addition:
Add the following new paragraph at the end of the subclause:
In this document, high-voltage circuits are secondary circuits comprising components for
generation and measurement for power supply of an X-ray tube, such as transformers,
voltage-multipliers and voltage-dividers, each rated for working-voltages a.c. above 1 000 V or
for (working-voltages) d.c. (above) 1 500 V.
6.7.3.4 Solid insulation
6.7.3.4.1 General
Addition:
Add the following new paragraph at the end of the subclause:
In the case of high voltage circuits, the term "solid insulation" is used to describe many different
types of constructions, including monolithic blocks of insulating material, insulating subsystems
composed of multiple insulating materials, including insulating liquids and insulating castings,
organized in layers or otherwise.
Conformity is checked by the 6.8.101 compliance test for high-voltage circuits.
6.8 Procedure for voltage tests
6.8.3.1 The a.c. voltage test
Replacement:
Replace the first sentence by the following sentence:
The voltage tester shall be capable of maintaining the test voltage throughout the test within
±5 % of the specified value.
Addition:
Add the following new subclause:
6.8.101 Procedure for voltage tests of high voltage circuits of X-ray equipment
The high-voltage circuit of the equipment is tested by applying no more than half the test voltage,
and then the test voltage is gradually raised over a period of 10 s ± 2 s to the full value, which is
maintained in intermittent mode and in continuous mode per Table 101.
Table 101 – Durations of high voltage strength test
High-voltage circuits tested in: Duration
Intermittent mode 3 min
Continuous mode 15 min
The test for the high-voltage circuit shall be made with a test voltage of:
– for nominal X-ray voltage less than 200 kV, 1,1 times the nominal X-ray tube voltage of the
equipment; or
– for nominal X-ray tube voltage of the equipment equal to or exceeding 200 kV, the nominal
X-ray tube voltage plus 20 kV.
The above test can be conducted on the system as a whole or on the separate parts individually.
For high-voltage generators intended for operation in both intermittent mode and continuous
mode, and in which the nominal X-ray tube voltage for continuous mode does not exceed 80 %
of that for intermittent mode, the test voltage for the high-voltage circuit shall be that of the
intermittent mode, and the test shall be carried out in that mode only.
If during the dielectric strength test, there is a RISK of overheating a transformer under test, it is
permitted to carry out the test at a higher supply frequency.
During the dielectric strength test, the test voltage in the high-voltage circuit should be kept as
close as possible to 100 %, and is not to be outside the range of 100 % and 105 % of the value
required.
– 16 – IEC 61010-2-091:2019 RLV IEC 2019
During the dielectric strength test, slight corona discharges in the high-voltage circuit are to be
disregarded.
High-voltage generators or subassemblies thereof, which are integrated with an X-ray tube
assembly, are to be tested with an appropriately loaded X-ray tube. If such high-voltage
generators do not have separate adjustment of the X-ray tube current, the duration of the
dielectric strength test is to be reduced to such an extent that the allowable X-ray tube load at
the increased X-ray tube voltage will not be exceeded.
7 Protection against mechanical HAZARDS
This clause of Part 1 is applicable except as follows:
7.1 General
Addition:
Add a new paragraph and a new note 101 following the existing note:
Conveyors of cabinet X-ray systems shall comply with the applicable requirements of 7.2 to 7.7,
and if any HAZARD is not adequately addressed by those subclauses, a RISK assessment (see
Clause 17) shall be performed.
NOTE 101 In the United States of America, conveyor systems are required to meet the requirements of
ANSI/ASME B20.1.
NOTE National regulations for conveyor systems can additionally apply. EXAMPLE: ASME B20.1,
ANSI/ASME B20.1 for the United States of America.
Replacement:
Replace the existing conformity statement with following new text:
Conformity is checked as specified in accordance with the specifications of 7.2 to 7.7 and, if
applicable, of Clause 17.
8 Resistance to mechanical stresses
This clause of Part 1 is applicable.
9 Protection against the spread of fire
This clause of Part 1 is applicable.
10 Equipment temperature limits and resistance to heat
This clause of Part 1 is applicable, except as follows:
Addition:
Add the following new subclauses:
10.1.101 Protection against excessive temperatures of X-ray tube assemblies
Where easily ACCESSIBLE EXTERNAL SURFACES of X-ray tube assemblies attain temperatures
exceeding those in Table 19, protective means shall be provided to prevent the OPERATOR from
contact with such parts in NORMAL USE.
NOTE Protective means can be ENCLOSURE or other barriers preventing access.
Compliance is checked by test of integrity of such means and by inspection of instructions for
use.
10.1.102 Protection against excessive temperatures of BEAM LIMITING DEVICES
BEAM-LIMITING DEVICES incorporating a light field-indicator shall be provided with one of the
following means to reduce the possible temperature rise occurring if the lamp remains energized
while the BEAM-LIMITING DEVICES are covered with drapes or other material, reducing the normal
heat dissipation:
a) an overtemperature protection device preventing the lamp from being energized if the
allowable maximum temperature of any EXTERNAL SURFACES of the BEAM-LIMITING DEVICES
has exceeded the limits of Table 19;
b) a time-limiting device preventing the lamp from remaining energized for a period exceeding
2 min after the most recent action by the OPERATOR to energize it. The manufacturer's
instructions shall provide details of required externally connected time-limiting switch;
c) a statement in the manufacturer's instructions giving details of the time-limiting switch to be
externally connected to perform the function described in item b) above.
Compliance is checked by inspection
11 Protection against HAZARDS from fluids and solid foreign objects
This clause of Part 1 is applicable.
12 Protection against radiation, including laser sources, and against sonic and
ultrasonic pressure
This clause of Part 1 is applicable, except as follows:
Replace 12.2 of Part 1 with the text below.
Replacement:
12.2 Equipment producing ionizing radiation
12.2.1 Ionizing radiation
12.2.1.1 General
Replacement:
Replace the first paragraph and the conformity statement with the following:
CABINET X-RAY SYSTEMS shall meet the requirements of 12.101.
Equipment containing or generating ionizing radiation from radioactive sources, and equipment
that generates X-radiation other than in CABINET X-RAY SYSTEMS shall meet the following
requirements.
– 18 – IEC 61010-2-091:2019 RLV IEC 2019
Conformity is checked as specified in 12.101, by inspection of the IEC 60405 compliance
documentation, or as specified in 12.2.1.2 or 12.2.1.3, as applicable.
Equipment containing or generating ionizing radiation (from either radioactive sources or
X-radiation) shall not create a HAZARD in normal or SINGLE FAULT CONDITION.
NOTE 1 See IEC 62598 for further information on the requirements for equipment which utilizes ionizing radiation.
NOTE 2 For X-ray and gamma radiation: 1 μSv/h = 0,1 mR/h and 5 μSv/h = 0,5 mR/h.
NOTE 3 Equipment that emits ionizing radiation is regulated by health authorities in most countries. These
regulations often address both the emissions of radiation from the equipment and the cumulative dose of radiation
received by the workers and others in the vicinity of the equipment. See the Ionizing Radiation Directive
(2013/59/EURATOM) or USA 29 CFR 1910.1096 as examples of these regulations.
Conformity is checked by inspection as specified in 12.2.1.101 to 12.2.1.104.
Addition:
Add the following new subclauses:
12.101 Ionizing radiation from CABINET X-RAY SYSTEMS
12.101.1 Emitted X-radiation
Radiation emitted from a CABINET X-RAY SYSTEM shall not exceed 5 µSv/h at any point 50 mm
outside the EXTERNAL SURFACE or at the plane of any APERTURE or PORT.
Conformity is checked by measurements covering the entire outer surface of the cabinet,
averaged over cross-sectional areas of 1 000 mm , with no linear dimension greater than 50 mm,
with the CABINET X-RAY SYSTEM operated at those combinations of X-ray tube potential, current,
beam orientation, and conditions of scatter which produce the maximum X-ray exposure at each
EXTERNAL SURFACE, APERTURE, and PORT with the DOORS and ACCESS PANELS fully closed, and
again with the DOORS and ACCESS PANELS in any other positions that permit the generation of
X-rays.
12.2.1.101 Limits for emitted X-radiation of cabinet X-ray systems
12.2.1.101.1 General
The ambient dose equivalent rate H*(10) (IEC 60050-395:2014, 395-05-43) emitted from a
cabinet X-ray system shall not exceed 5 µSv/h at any point 50 mm outside the EXTERNAL
SURFACE or at the plane of any APERTURE or PORT.
The measurements shall be conducted at the maximum available voltage of any high-voltage
generator, or highest possible voltage in fault condition
Conformity is checked by the measurements of 12.2.1.101.2 or 12.2.1.101.3, as applicable.
NOTE Specifications for radiation measurement equipment can be found in IEC 60846-1.
12.2.1.101.2 Measurement of emitted X-radiation from PROTECTED EQUIPMENT
Radiation is measured covering the entire EXTERNAL SURFACE of the cabinet, averaged over
cross-sectional areas of 1 000 mm , with no linear dimension greater than 50 mm, with the
cabinet X-ray system operated at those combinations of X-ray tube potential, current, beam
orientation, and conditions of scatter which produce the maximum X-ray exposure at each
EXTERNAL SURFACE.
Measurement is conducted with the DOORS and ACCESS PANELS fully closed, and again with the
DOORS and ACCESS PANELS in any other positions that permit the generation of X-rays.
12.2.1.101.3 Measurement of emitted X-radiation from PARTIALLY PROTECTED EQUIPMENT
Radiation is measured covering the entire EXTERNAL SURFACE of the cabinet, averaged over
cross-sectional areas of 1 000 mm , with no linear dimension greater than 50 mm, with the
cabinet X-ray system operated at those combinations of X-ray tube potential, current, beam
orientation, and conditions of scatter which produce the maximum X-ray exposure at each
EXTERNAL SURFACE.
Measurement is conducted with the DOORS and ACCESS PANELS fully closed, and again with the
DOORS and ACCESS PANELS in any other positions that permit the generation of X-rays, except
any flexible radiation absorbents used to close any APERTURE or PORT, which shall remain in their
normal closed position.
For this measurement, a scatter body shall be used that represents the typical scanned obj
...
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
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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
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
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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
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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 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.
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.
– 6 – IEC 61010-2-091:2019 IEC 2019
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.
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.
– 8 – IEC 61010-2-091:2019 IEC 2019
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.
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.
– 10 – IEC 61010-2-091:2019 IEC 2019
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.
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:
– 12 – IEC 61010-2-091:2019 IEC 2019
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 following new items:
aa) in the instructions for use, the loading factors shall be stated as described below. The
following combinations and data shall be stated:
– the corresponding nominal X-ray tube voltage together with the highest X-ray tube
current obtainable from the equipment when operated at that X-ray tube voltage;
– the corresponding highest X-ray tube current together with the highest X-ray tube voltage
obtainable from the equipment when operating at that X-ray tube current;
– the corresponding combination of X-ray tube voltage and X-ray tube current which results
in the highest electric power in the high-voltage circuit.
The nominal electric power shall be given together with the combination of X-ray tube
voltage and X-ray tube current and, if applicable, the loading time.
The range of acceptable X-ray tube current, X-ray tube voltage and load times may be given
as a table or a curve showing the dependences.
bb) the instructions for use shall state the maximum symmetrical radiation field of the integrated
X-ray source assembly;
cc) the instructions for use shall contain a description of the particular handling and
maintenance of any X-ray image receptor.
Replacement:
Replace the conformity statement with:
Compliance is checked by inspection of the instructions for use.
Addition:
Add the following new subclause:
5.4.101 Additional documentation for cabinet X-ray systems
RESPONSIBLE BODY shall include:
Instructions for the
a) voltage, current, and, if applicable, duty cycle RATINGS of the X-ray equipment;
b) instructions concerning radiological safety procedures and precautions which may be
necessary because of unique features of the equipment;
c) a schedule of maintenance; and
d) a recommendation to consult national authorities to determine any local operational
requirements.
Instructions for service personnel shall include:
e) instructions for test after repair or maintenance.
Instructions for installation and commissioning shall also include instructions for assembly,
adjustment and tests to ensure that the equipment is safe after it is commissioned.
Conformity is checked by inspection.
6 Protection against electric shock
This clause of Part 1 is applicable, except as follows:
6.5.2 PROTECTIVE BONDING
Addition:
Add the following new subclause:
6.5.2.101 X-ray tube assembly
There shall be electrical continuity between the screen of a fitted high-voltage cable and the
ACCESSIBLE metal parts of its receptacle on the X-ray tube assembly.
ACCESSIBLE by operator or service
In addition, high voltage cables, carrying X-ray tube current,
personnel, shall incorporate a flexible conductive screen having a maximum resistance per unit
length of 1 Ω/m covered with a non-conductive material capable of protecting the screen against
mechanical damage in NORMAL USE.
Such screens shall be connected to the conductive ENCLOSURE of the high voltage generator and
to that of the x-ray tube assembly.
An exception to this requirement are high voltage cables carrying x-ray tube current within a fully
enclosed and fully integrated X-ray generator / X-ray tube assembly referred to as a monoblock.
Compliance is checked by visual inspection and by measurement.
Flexible conductive screens shall not be recognized as satisfying a requirement for a protective
earth connection between the devices connected by the cable.
6.7 Insulation requirements
6.7.1.5 Requirements for insulation according to type of circuit
Addition:
Add the following new paragraph at the end of the subclause:
Isolation between high voltage circuits in the generator, wiring or X-ray tube and the ACCESSIBLE
circuit is to be based on the actual WORKING VOLTAGE stressing the said isolation.
Isolation requirements for any stator and stator circuit used for the operation of any rotating
anode of the X-ray tube is to be referred to the voltage existing after reduction of the stator
supply voltage to its steady state operating value.
– 14 – IEC 61010-2-091:2019 IEC 2019
6.7.3 Insulation for secondary circuits derived from MAINS CIRCUITS of OVERVOLTAGE
CATEGORY II up to 300 V
6.7.3.1 General
Addition:
Add the following new paragraph at the end of the subclause:
In this document, high-voltage circuits are secondary circuits comprising components for
generation and measurement for power supply of an X-ray tube, such as transformers,
voltage-multipliers and voltage-dividers, each rated for working-voltages a.c. above 1 000 V or
for (working-voltages) d.c. (above) 1 500 V.
6.7.3.4 Solid insulation
6.7.3.4.1 General
Addition:
Add the following new paragraph at the end of the subclause:
In the case of high voltage circuits, the term "solid insulation" is used to describe many different
types of constructions, including monolithic blocks of insulating material, insulating subsystems
composed of multiple insulating materials, including insulating liquids and insulating castings,
organized in layers or otherwise.
Conformity is checked by the 6.8.101 compliance test for high-voltage circuits.
6.8 Procedure for voltage tests
6.8.3.1 The a.c. voltage test
Replacement:
Replace the first sentence by the following sentence:
The voltage tester shall be capable of maintaining the test voltage throughout the test within
±5 % of the specified value.
Addition:
Add the following new subclause:
6.8.101 Procedure for voltage tests of high voltage circuits of X-ray equipment
The high-voltage circuit of the equipment is tested by applying no more than half the test voltage,
and then the test voltage is gradually raised over a period of 10 s ± 2 s to the full value, which is
maintained in intermittent mode and in continuous mode per Table 101.
Table 101 – Durations of high voltage strength test
High-voltage circuits tested in: Duration
Intermittent mode 3 min
Continuous mode 15 min
The test for the high-voltage circuit shall be made with a test voltage of:
– for nominal X-ray voltage less than 200 kV, 1,1 times the nominal X-ray tube voltage of the
equipment; or
– for nominal X-ray tube voltage of the equipment equal to or exceeding 200 kV, the nominal
X-ray tube voltage plus 20 kV.
The above test can be conducted on the system as a whole or on the separate parts individually.
For high-voltage generators intended for operation in both intermittent mode and continuous
mode, and in which the nominal X-ray tube voltage for continuous mode does not exceed 80 %
of that for intermittent mode, the test voltage for the high-voltage circuit shall be that of the
intermittent mode, and the test shall be carried out in that mode only.
If during the dielectric strength test, there is a RISK of overheating a transformer under test, it is
permitted to carry out the test at a higher supply frequency.
During the dielectric strength test, the test voltage in the high-voltage circuit should be kept as
close as possible to 100 %, and is not to be outside the range of 100 % and 105 % of the value
required.
During the dielectric strength test, slight corona discharges in the high-voltage circuit are to be
disregarded.
High-voltage generators or subassemblies thereof, which are integrated with an X-ray tube
assembly, are to be tested with an appropriately loaded X-ray tube. If such high-voltage
generators do not have separate adjustment of the X-ray tube current, the duration of the
dielectric strength test is to be reduced to such an extent that the allowable X-ray tube load at
the increased X-ray tube voltage will not be exceeded.
7 Protection against mechanical HAZARDS
This clause of Part 1 is applicable except as follows:
7.1 General
Addition:
Add a new paragraph and a new note following the existing note:
Conveyors of cabinet X-ray systems shall comply with the applicable requirements of 7.2 to 7.7,
and if any HAZARD is not adequately addressed by those subclauses, a RISK assessment (see
Clause 17) shall be performed.
NOTE National regulations for conveyor systems can additionally apply. EXAMPLE: ASME B20.1,
ANSI/ASME B20.1 for the United States of America.
Replacement:
Replace the existing conformity statement with following new text:
Conformity is checked in accordance with the specifications of 7.2 to 7.7 and, if applicable, of
Clause 17.
– 16 – IEC 61010-2-091:2019 IEC 2019
8 Resistance to mechanical stresses
This clause of Part 1 is applicable.
9 Protection against the spread of fire
This clause of Part 1 is applicable.
10 Equipment temperature limits and resistance to heat
This clause of Part 1 is applicable, except as follows:
Addition:
Add the following new subclauses:
10.1.101 Protection against excessive temperatures of X-ray tube assemblies
Where easily ACCESSIBLE EXTERNAL SURFACES of X-ray tube assemblies attain temperatures
exceeding those in Table 19, protective means shall be provided to prevent the OPERATOR from
contact with such parts in NORMAL USE.
NOTE Protective means can be ENCLOSURE or other barriers preventing access.
Compliance is checked by test of integrity of such means and by inspection of instructions for
use.
10.1.102 Protection against excessive temperatures of BEAM LIMITING DEVICES
BEAM-LIMITING DEVICES incorporating a light field-indicator shall be provided with one of the
following means to reduce the possible temperature rise occurring if the lamp remains energized
while the BEAM-LIMITING DEVICES are covered with drapes or other material, reducing the normal
heat dissipation:
a) an overtemperature protection device preventing the lamp from being energized if the
allowable maximum temperature of any EXTERNAL SURFACES of the BEAM-LIMITING DEVICES
has exceeded the limits of Table 19;
b) a time-limiting device preventing the lamp from remaining energized for a period exceeding
2 min after the most recent action by the OPERATOR to energize it. The manufacturer's
instructions shall provide details of required externally connected time-limiting switch;
c) a statement in the manufacturer's instructions giving details of the time-limiting switch to be
externally connected to perform the function described in item b) above.
Compliance is checked by inspection
11 Protection against HAZARDS from fluids and solid foreign objects
This clause of Part 1 is applicable.
12 Protection against radiation, including laser sources, and against sonic and
ultrasonic pressure
This clause of Part 1 is applicable, except as follows:
Replace 12.2 of Part 1 with the text below.
Replacement:
12.2 Equipment producing ionizing radiation
12.2.1 Ionizing radiation
12.2.1.1 General
Equipment containing or generating ionizing radiation (from either radioactive sources or
HAZARD in normal or SINGLE FAULT CONDITION.
X-radiation) shall not create a
NOTE 1 See IEC 62598 for further information on the requirements for equipment which utilizes ionizing radiation.
NOTE 2 For X-ray and gamma radiation: 1 μSv/h = 0,1 mR/h and 5 μSv/h = 0,5 mR/h.
NOTE 3 Equipment that emits ionizing radiation is regulated by health authorities in most countries. These
regulations often address both the emissions of radiation from the equipment and the cumulative dose of radiation
received by the workers and others in the vicinity of the equipment. See the Ionizing Radiation Directive
(2013/59/EURATOM) or USA 29 CFR 1910.1096 as examples of these regulations.
Conformity is checked by inspection as specified in 12.2.1.101 to 12.2.1.104.
Addition:
Add the following new subclauses:
12.2.1.101 Limits for emitted X-radiation of cabinet X-ray systems
12.2.1.101.1 General
The ambient dose equivalent rate H*(10) (IEC 60050-395:2014, 395-05-43) emitted from a
cabinet X-ray system shall not exceed 5 µSv/h at any point 50 mm outside the EXTERNAL
SURFACE or at the plane of any APERTURE or PORT.
The measurements shall be conducted at the maximum available voltage of any high-voltage
generator, or highest possible voltage in fault condition
Conformity is checked by the measurements of 12.2.1.101.2 or 12.2.1.101.3, as applicable.
NOTE Specifications for radiation measurement equipment can be found in IEC 60846-1.
12.2.1.101.2 Measurement of emitted X-radiation from PROTECTED EQUIPMENT
Radiation is measured covering the entire EXTERNAL SURFACE of the cabinet, averaged over
cross-sectional areas of 1 000 mm , with no linear dimension greater than 50 mm, with the
cabinet X-ray system operated at those combinations of X-ray tube potential, current, beam
orientation, and conditions of scatter which produce the maximum X-ray exposure at each
EXTERNAL SURFACE.
Measurement is conducted with the DOORS and ACCESS PANELS fully closed, and again with the
DOORS and ACCESS PANELS in any other positions that permit the generation of X-rays.
12.2.1.101.3 Measurement of emitted X-radiation from PARTIALLY PROTECTED EQUIPMENT
Radiation is measured covering the entire EXTERNAL SURFACE of the cabinet, averaged over
cross-sectional areas of 1 000 mm , with no linear dimension greater than 50 mm, with the
cabinet X-ray system operated at those combinations of X-ray tube potential, current, beam
orientation, and conditions of scatter which produce the maximum X-ray exposure at each
EXTERNAL SURFACE.
– 18 – IEC 61010-2-091:2019 IEC 2019
Measurement is conducted with the DOORS and ACCESS PANELS fully closed, and again with the
DOORS and ACCESS PANELS in any other positions that permit the generation of X-rays, except
any flexible radiation absorbents used to close any APERTURE or PORT, which shall remain in their
normal closed position.
For this measurement, a scatter body shall be used that represents the typical scanned objects.
As in the case of baggage inspection systems, the scanned objects vary considerably in size,
content and material, a standardized polyoxymethylene (POM) scatter body shall be used (see
Figure AA.1 in Annex AA). The scatter body shall be positioned in the middle of the belt and in
the center of the beam.
For multiple beam systems, it shall be ensured that all beams hit a scatter body by using one
scatter body for each beam or positioning one scatter body in several beams where possible.
12.2.1.102 Construction
Cabinet X-ray systems may be provided with a cabinet bottom or may be designed to be
permanently mounted to a floor of a building, whereby the floor of the building becomes the
bottom of the system. If the cabinet X-ray system is designed to be permanently mounted to a
floor of a building then instructions shall state that radiation measurements must be performed
in any dwelling space located below the cabinet after it is installed, to ensure that the limit given
in 12.2.1.101.1 is not exceeded, and that additional shielding may be required.
Conformity is checked by inspection.
12.2.1.103 Controls
The cabinet X-ray system shall be equipped with the following controls, ACCESSIBLE to the
OPERATOR:
a) a key-actuated control to ensure that X-radiation is not possible with the key removed;
b) one or more controls to initiate and terminate X-radiation other than by the functioning of an
INTERLOCK or the MAINS switch;
c) if designed so that humans may enter the cabinet fo
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