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

IEC 61010-2-091:2012 specifies particular safety requirements for CABINET X-RAY SYSTEMS. 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 during generation of X-radiation. These CABINET X-RAY SYSTEMS are used in industrial, commercial, and public environments, for example, to inspect materials, to analyze materials, and to screen baggage.
This publication is to be read in conjunction with IEC 61010-1:2010.

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

La CEI 61010-2-091:2012 définit les exigences de sécurité particulières pour les EQUIPEMENTS A RAYONS X MONTES EN ARMOIRE. Un EQUIPEMENT A RAYONS X MONTE EN ARMOIRE est un équipement doté d'un tube radiogène installé dans une armoire qui, indépendamment des structures architecturales existantes à l'exception du sol sur lequel il peut être placé, est destiné à contenir au moins une partie d'un matériau en cours d'irradiation, à fournir une atténuation du rayonnement et à maintenir le personnel à l'extérieur de son enceinte durant la production de rayons X. Ces EQUIPEMENTS A RAYONS X MONTES EN ARMOIRE sont utilisés dans des environnements industriel, commercial et public pour l'inspection et l'analyse des matériaux, et pour l'examen des bagages.
Cette publication doit être lue conjointement avec la CEI 61010-1:2010.

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IEC 61010-2-091


®


Edition 1.0 2012-06



INTERNATIONAL



STANDARD



NORME
INTERNATIONALE
GROUP SAFETY PUBLICATION
PUBLICATION GROUPÉE DE SÉCURITÉ
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



IEC 61010-2-091:2012

---------------------- Page: 1 ----------------------
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IEC 61010-2-091



®



Edition 1.0 2012-06







INTERNATIONAL





STANDARD







NORME



INTERNATIONALE




GROUP SAFETY PUBLICATION

PUBLICATION GROUPÉE DE SÉCURITÉ




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

PRICE CODE
INTERNATIONALE

CODE PRIX N


ICS 19.080; 71.040.10 ISBN 978-2-83220-145-9



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

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

---------------------- Page: 3 ----------------------
– 2 – 61010-2-091 © IEC:2012



CONTENTS

FOREWORD . 3


1 Scope and object . 5

2 Normative references . 6

3 Terms and definitions . 6


4 Tests . 7

5 Marking and documentation . 7

6 Protection against electric shock . 8

7 Protection against mechanical HAZARDS . 8
8 Resistance to mechanical stresses . 9
9 Protection against the spread of fire . 9
10 Equipment temperature limits and resistance to heat . 9
11 Protection against HAZARDS from fluids . 9
12 Protection against radiation, including laser sources, and against sonic and
ultrasonic pressure . 9
13 Protection against liberated gases and substances, explosion and implosion . 10
14 Components and subassemblies . 11
15 Protection by interlocks . 11
16 HAZARDS resulting from application . 11
17 RISK assessment . 12
Annex L (informative) Index of defined terms . 13
Bibliography . 14

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61010-2-091 © IEC:2012 – 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,
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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
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between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
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services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
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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 61010-2-91 has been prepared by IEC technical committee 66:
Safety of measuring, control and laboratory equipment.
It has the status of a group safety publication as specified in IEC Guide 104.
The text of this standard is based on the following documents:
FDIS Report on voting
66/462/FDIS 66/470/RVD

Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.

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– 4 – 61010-2-091 © IEC:2012


This Part 2-091 is intended to be used in conjunction with IEC 61010-1. It was established on

the basis of the third edition (2010). Consideration may be given to future editions of, or

amendments to, IEC 61010-1.


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.


Where a particular subclause of Part 1 is not mentioned in this part 2, that subclause applies

as far as is reasonable. Where this part states “addition”, “modification”, “replacement”, or

“deletion”, the relevant requirement, test specification or note in Part 1 should be adapted

accordingly.
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).
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
The following differing practices exist in the countries indicated below:
– 7.1: Conveyor systems are required to meet the requirements of
ANSI/ASME B20.1 (USA).
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 publication will remain unchanged until
the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be

• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

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61010-2-091 © IEC:2012 – 5 –


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:
1.1.1 Equipment included in scope
Replacement:
Replace the text with the following:
This part of IEC 61010 specifies particular safety requirements for CABINET X-RAY SYSTEMS.
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 during generation of X-radiation.
These CABINET X-RAY SYSTEMS are used in industrial, commercial, and public environments,
for example, to inspect materials, to analyze 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:
1) equipment intended to be used within a shielded room which excludes personnel
during operation;

2) equipment intended to be used with separate portable or temporary shielding;
3) equipment intended to produce an emerging beam of X-radiation.
1.2.1 Aspects included in scope
Addition:
Add the following text at 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.

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– 6 – 61010-2-091 © IEC:2012


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 definitions:
3.2.101
ACCESS PANEL
barrier or panel which is designed to be removed or opened 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
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.

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 dimension that does not permit complete
insertion into the cabinet

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61010-2-091 © IEC:2012 – 7 –


4 Tests


This clause of Part 1 is applicable.



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
Addition:
Add the following new subclauses:
5.1.101 Markings for CABINET X-RAY SYSTEMS
The equipment shall be marked at the location of each control which may be used to initiate
X-ray generation, with the text, “Caution: X-rays generated when activated”, or substantially
similar text.
Equipment shall be marked adjacent to each PORT which is sufficiently large to admit human
body parts to the direct X-ray beam, with the text, “Caution: X-ray hazard. Do not insert any
part of the body when system is activated”, or substantially similar text.
The indicators required by 5.1.102 shall be marked “X-ray on”, or equivalent.
NOTE 1 If a milliammeter is used as one of the required indicators, it is marked as specified in 5.1.102, and is not
marked “X-ray on”.
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 c) and 5.1.102 d).
NOTE 2 National regulations may require a nationally-accepted language for safety instructions and markings.

Conformity is checked by inspection.
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.

---------------------- Page: 9 ----------------------
– 8 – 61010-2-091 © IEC:2012


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.
5.4.1 General
Replacement:
Replace item d) with the following item:
d) the information specified in 5.4.2 to 5.4.6 and 5.4.101;
Addition:
Add the following new subclause:
5.4.101 Documentation for cabinet X-ray systems
Instructions for the RESPONSIBLE BODY shall include:
a) voltage, current, and, if applicable, duty cycle RATINGS of the X-ray generation
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 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.

Instructions for installation and commissioning shall also include instructions for assembly,
adjustment, and test 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.
7 Protection against mechanical HAZARDS
This clause of Part 1 is applicable, except as follows:

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61010-2-091 © IEC:2012 – 9 –


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.
Replacement:
Replace the conformity statement with:
Conformity is checked as specified in 7.2 to 7.7, and if applicable, 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.
11 Protection against HAZARDS from fluids
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:
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.
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.

---------------------- Page: 11 ----------------------
– 10 – 61010-2-091 © IEC:2012


Addition:


Add the following new subclause:


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,
2
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-
EXTERNAL SURFACE, APERTURE, and PORT with the DOORS and ACCESS
ray exposure at each
PANELS fully closed, and again with the DOORS and ACCESS PANELS in any other positions that
permit the generation of X-rays.
12.101.2 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 below the cabinet after it is installed, to ensure that the limit
of 12.101.1 is not exceeded, and that additional shielding may be required.
Conformity is checked by inspection.
12.101.3 Controls
The CABINET X-RAY SYSTEM shall be equipped with the following controls:
a) a key-actuated control to ensure that X-ray generation is not possible with the key
removed;
b) one or more controls to initiate and terminate X-ray generation other than by
functioning of an interlock or the MAINS switch;
c) if designed so that humans may enter the cabinet for specified purposes, a control
within the cabinet for preventing and terminating X-ray generation, which cannot be
reset, overridden, or bypassed from the outside of the cabinet,
d) if the system may be located where the public has access, a control to ensure
operator presence at the control area before X-ray generation can be initiated or
maintained;
e) if the system may be located where the public has access, a control to terminate the
X-ray exposure or the preset succession of exposures at any time.
CABINET X-RAY SYSTEMS designed so that humans may enter the cabinet for specified
purposes shall not have any means of initiating X-ray generation from within the cabinet.
Conformity is checked by inspection.
13 Protection against liberated gases and substances, explosion and implosion
This clause of Part 1 is applicable.

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61010-2-091 © IEC:2012 – 11 –


14 Components and subassemblies


This clause of Part 1 is applicable.



15 Protection by interlocks


This clause of Part 1 is applicable, except as follows:


15.1 General


Replacement:
Replace the text and conformity statement with the following text:
Interlocks used to protect OPERATORS from HAZARDS other than X-radiation shall prevent the
OPERATOR from being exposed to the HAZARD before the HAZARD is removed and shall meet
the requirements of 15.2 and 15.3.
Interlocks used only to protect OPERATORS and bystanders against X-radiation HAZARDS shall
meet the requirements of 15.101.
Interlocks used to protect both against X-radiation HAZARDS and other HAZARDS shall meet the
requirements of 15.2, 15.3, and 15.101.
Conformity is checked by inspection and as specified in 15.2, 15.3, and 15.101, as applicable.
Addition:
Add the following new subclause:
15.101 Interlocks for CABINET X-RAY SYSTEMS
Interlocks for protection against X-radiation shall meet the requirements of 15.3, or either
ISO 13849-1 or IEC 62061.
Each DOOR of a CABINET X-RAY SYSTEM shall have a minimum of two independent interlocks.
Each of the required interlocks on each DOOR shall be designed to disconnect the power
supply circuit to the high-voltage generator, and this operation shall not be dependent on any
action other than opening the DOOR.

Each ACCESS PANEL of a CABINET X-RAY SYSTEM shall have at least one interlock or shall
require a TOOL to open. The equipment shall be designed so that, following interruption of X-
ray generation by the functioning of any interlock, the OPERATOR is obliged to take positive
action to resume X-ray generation.
A SINGLE FAULT CONDITION shall not disable more than one required interlock.
Conformity is checked by inspection accordin
...

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