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

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

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

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

General Information

Status
Published
Publication Date
14-Feb-2019
Current Stage
PPUB - Publication issued
Completion Date
15-Feb-2019
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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
IEC 61010-2-091:2019-02(en-fr)
---------------------- Page: 1 ----------------------
THIS PUBLICATION IS COPYRIGHT PROTECTED
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---------------------- Page: 2 ----------------------
IEC 61010-2-091
Edition 2.0 2019-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Safety requirements for electrical equipment for measurement, control, and
laboratory use –
Part 2-091: Particular requirements for cabinet X-ray systems
Règles de sécurité pour appareils électriques de mesurage, de régulation et de
laboratoire –
Partie 2-091: Exigences particulières pour les équipements à rayons X montés
en armoire
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 19.080; 71.040.10 ISBN 978-2-8322-6518-5

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

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

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 3 ----------------------
– 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

---------------------- Page: 4 ----------------------
IEC 61010-2-091:2019  IEC 2019 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT
FOR MEASUREMENT, CONTROL, AND LABORATORY USE –
Part 2-091: Particular requirements for cabinet X-ray systems
FOREWORD

1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising

all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international

co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in

addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,

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preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with

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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 61010-2-091 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)
---------------------- Page: 5 ----------------------
– 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.
---------------------- Page: 6 ----------------------
IEC 61010-2-091:2019  IEC 2019 – 5 –

The committee has decided that the contents of this document will remain unchanged until the

stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to

the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
---------------------- Page: 7 ----------------------
– 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.
---------------------- Page: 8 ----------------------
IEC 61010-2-091:2019  IEC 2019 – 7 –
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT
FOR MEASUREMENT, CONTROL, AND LABORATORY USE –
Part 2-091: Particular requirements for cabinet X-ray systems
1 Scope and object
This clause of Part 1 is applicable, except as follows:
1.1 Scope
1.1.1 Equipment included in scope
Deletion:
Delete the first paragraph.
Replacement:
Replace the second paragraph (above items a) to c)) with the following new text:

This part of IEC 61010 specifies particular safety requirements for cabinet X-ray systems, which

fall under any of categories a), b) or c) below.
Addition:
Add the two following new paragraphs at the end of the subclause:
Equipment covered by this document can be both PROTECTED EQUIPMENT or PARTIALLY
PROTECTED EQUIPMENT, with X-ray generator voltage up to 500 kV.

A cabinet X-ray system is a system that contains an X-ray tube installed in a cabinet, which,

independently of existing architectural structures except the floor on which it may be placed, is

intended to contain at least that portion of a material being irradiated, provide radiation

attenuation and prevent operator access to the radiation beam, during generation of X-radiation.

These cabinet X-ray systems are used in industrial, commercial, and public environments, for

example, to inspect materials, to analyse materials, and to screen baggage.
1.1.2 Equipment excluded from scope
Addition:
Add the following new items to the list:
aa) Equipment intended to apply X-radiation to humans or animals;

bb) Equipment incorporating an X-ray tube but not incorporating complete shielding against

X-radiation HAZARDS, such as:

– equipment intended to be used within a shielded room which excludes personnel during

operation;
– equipment intended to be used with separate portable or temporary shielding;
– equipment intended to produce an emerging beam of X-radiation.
---------------------- Page: 9 ----------------------
– 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.
---------------------- Page: 10 ----------------------
IEC 61010-2-091:2019  IEC 2019 – 9 –
3.2.104
EXTERNAL SURFACE

outside surface of the cabinet X-ray system, including DOORS, ACCESS PANELS, latches, control

knobs and other permanently mounted hardware, the virtual surface across any APERTURE or

PORT, and the bottom of the cabinet
3.2.105
PORT

opening in the EXTERNAL SURFACE of the cabinet which is designed to remain open during

generation of X-rays, for the purpose of conveying objects into and out of the cabinet or for

partial insertion for irradiation of an object with dimensions that do not permit complete insertion

into the cabinet
3.2.106
PROTECTED EQUIPMENT

cabinet X-ray system without any APERTURE or PORT, which would allow access to any area with

X-radiation

Note 1 to entry: Access can be prevented through INTERLOCK protected DOORS, PORTS, APERTURES or ACCESS

PANELS.
3.2.107
PARTIALLY PROTECTED EQUIPMENT

cabinet X-ray system with APERTURE or PORT, allowing access to any area with X-radiation

Note 1 to entry: Access to the X-ray beam or scattered X-radiation could be prevented through a combination of

ENCLOSURE and flexible radiation absorbents, for example, one or several curtains containing lead or another radiation

absorbing material.
3.2.108
BEAM-LIMITING DEVICE

device to limit the radiation field, such as a collimator, a cone or an APERTURE, intended to

restrict the dimensions of X-ray field
3.2.109
INTERLOCK

arrangement of components or devices operating together, intended to prevent a HAZARD or

specific operation whenever safety is compromised by access to the interior of the system,

operational irregularity or equipment failure

[SOURCE: IEC 62463:2010, 3.11, modified – The term "safety interlocks" has been replaced

with "interlock" and the wording "interrupt the generation of X-radiation" has been replaced with

HAZARD or specific operation".]
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.

---------------------- Page: 11 ----------------------
– 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.

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IEC 61010-2-091:2019  IEC 2019 – 11 –
5.1.101.2 BEAM-LIMITING DEVICES

BEAM-LIMITING DEVICES detachable in NORMAL USE by an OPERATOR shall be provided with the

following markings:
– those required in IEC 61010-1:2010 and IEC 61010-1:2010/AMD1:2016, 5.1;
– serial designation or individual identification;
– total filtration in terms of quality equivalent filtration.
Conformity is checked by inspection.
5.1.101.3 X-ray tubes

When an X-ray tube is constructed as a component of the cabinet X-ray system, the following is

applicable. The markings on the X-ray tube shall remain readable when the X-ray tube is

dismantled from the X-ray tube housing. The markings shall enable individual products, series or

types to be correlated with their accompanying documents.
X-ray tubes shall be provided with the following markings:
– name or trademark of the manufacturer;
– model or type reference;
– individual identification.

The above markings may be given in the form of a combined designation explained in the

accompanying documents.
Conformity is checked by inspection.

The requirements for X-ray tube assemblies apply when the X-ray tube is part of a subassembly

and not a stand-alone component.
5.1.101.4 X-ray tube assemblies

When X-ray tube assemblies are constructed as components of the cabinet X-ray system, the

following is applicable:

– X-ray tube assemblies shall be provided with the following markings on the outside:

• name or trademark of the manufacturer;
• model or type reference;
• individual identification;
• nominal X-ray tube voltage for which the X-ray tube assembly is designed;
– and, as applicable, the following additional markings:
• indication of the polarity of the receptacles for high-voltage cables;
• permanent filtration.
Conformity is checked by inspection.
5.4 Documentation
5.4.1 General
Replacement:
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– 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

volta
...

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