SIST EN IEC 61675-1:2022
(Main)Radionuclide imaging devices - Characteristics and test conditions - Part 1: Positron emission tomographs (IEC 61675-1:2022)
Radionuclide imaging devices - Characteristics and test conditions - Part 1: Positron emission tomographs (IEC 61675-1:2022)
This part of IEC 61010 specifies safety requirements for electrical equipment and its
accessories within the categories a) through c), wherever it is intended to be used, whenever
that equipment incorporates one or more of the following characteristics:
– A REFRIGERATING SYSTEM that is acted on or impacted by an integral heating function such
that the combined heating and REFRIGERATING SYSTEM generates additional and/or more
severe HAZARDS than those for the two systems if treated separately.
– The materials being treated in the intended application introduce significant heat into the
REFRIGERATING SYSTEM, so that the REFRIGERATING SYSTEM in the application yields
additional and/or more severe HAZARDS than those for the REFRIGERATING SYSTEM if
operated at the maximum RATED ambient temperature alone.
– An irradiation function for the materials being treated presenting additional HAZARDS.
– A function to expose the materials being treated to excessive humidity, carbon dioxide,
salt mist, or other substances which can result in additional HAZARDS.
– A function of MECHANICAL MOVEMENT presenting additional HAZARDS.
– Provision for an OPERATOR to walk in to the operating area to load or unload the materials
being treated.
Bildgebende Systeme in der Nuklearmedizin - Merkmale und Prüfbedingungen - Teil 1: Positronen-Emissions-Tomographen (IEC 61675-1:2022)
Dispositifs d'imagerie par radionucléides - Caractéristiques et conditions d'essai - Partie 1: Tomographes à émission de positrons (IEC 61675-1:2022)
IEC 61675-1:2022 est disponible sous forme de IEC 61675-1:2022 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.
L'IEC 61675-1:2022 spécifie la terminologie et les méthodes d'essai relatives à la description des caractéristiques des TOMOGRAPHES A EMISSION DE POSITRONS. Les TOMOGRAPHES A EMISSION DE POSITRONS détectent le RAYONNEMENT D'ANNIHILATION des RADIONUCLEIDES qui émettent des positrons par la DETECTION EN COÏNCIDENCE. L'IEC 61675-1:2022 annule et remplace la deuxième édition parue en 2013. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente: des exigences ont été modifiées ou ajoutées quant aux aspects techniques de la RESOLUTION SPATIALE, du mesurage de la sensibilité, de la FRACTION DE DIFFUSION, de la performance du TAUX DE COMPTAGE, de la qualité d'image et de l’exactitude de la superposition d’images en TEP ou CT.
Naprave za slikanje z radionuklidi - Karakteristike in preskusni pogoji - 1. del: Pozitronska emisijska tomografija (IEC 61675-1:2022)
Ta del standarda IEC 61010 določa varnostne zahteve za električno opremo in njene dodatke v kategorijah a) do c), kjer koli je namenjena za uporabo in ima eno ali več spodaj navedenih lastnosti: – HLADILNI SISTEM, ki ga upravlja ali nanj vpliva vgrajena grelna funkcija tako, da skupni grelni in HLADILNI SISTEM ustvarjata dodatne in/ali večje NEVARNOSTI, kot če bi bila sistema neodvisna; – materiali, ki se obdelujejo pri namenski uporabi, vpeljejo znatno količino toplote v HLADILNI SISTEM, tako da HLADILNI SISTEM pri taki uporabi ustvarja dodatne in/ali večje NEVARNOSTI, kot če bi zgolj deloval pri največji NAZIVNI temperaturi okolja; – funkcija obsevanja obdelovanih materialov, ki predstavlja dodatne NEVARNOSTI; – funkcija za izpostavljanje materialov, ki se obdelujejo, prekomerni vlagi, ogljikovemu dioksidu, solni megli ali drugim snovem, ki lahko povzročijo dodatne NEVARNOSTI; – funkcija MEHANSKEGA GIBANJA, ki predstavlja dodatne NEVARNOSTI; – določba, ki UPRAVLJAVCU dovoljuje, da vstopi na območje delovanja, da naloži ali razloži obdelovane materiale.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN IEC 61675-1:2022
01-junij-2022
Nadomešča:
SIST EN 61675-1:2016
Naprave za slikanje z radionuklidi - Karakteristike in preskusni pogoji - 1. del:
Pozitronska emisijska tomografija (IEC 61675-1:2022)
Radionuclide imaging devices - Characteristics and test conditions - Part 1: Positron
emission tomographs (IEC 61675-1:2022)
Bildgebende Systeme in der Nuklearmedizin - Merkmale und Prüfbedingungen - Teil 1:
Positronen-Emissions-Tomographen (IEC 61675-1:2022)
Dispositifs d'imagerie par radionucléides - Caractéristiques et conditions d'essai - Partie
1: Tomographes à émission de positrons (IEC 61675-1:2022)
Ta slovenski standard je istoveten z: EN IEC 61675-1:2022
ICS:
11.040.50 Radiografska oprema Radiographic equipment
SIST EN IEC 61675-1:2022 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN IEC 61675-1:2022
EUROPEAN STANDARD EN IEC 61675-1
NORME EUROPÉENNE
EUROPÄISCHE NORM April 2022
ICS 11.040.50 Supersedes EN 61675-1:2014
English Version
Radionuclide imaging devices - Characteristics and test
conditions - Part 1: Positron emission tomographs
(IEC 61675-1:2022)
Dispositifs d'imagerie par radionucléides - Caractéristiques Bildgebende Systeme in der Nuklearmedizin - Merkmale
et conditions d'essai - Partie 1: Tomographes à émission de und Prüfbedingungen - Teil 1: Positronen-Emissions-
positrons Tomographen
(IEC 61675-1:2022) (IEC 61675-1:2022)
This European Standard was approved by CENELEC on 2022-04-22. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 61675-1:2022 E
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SIST EN IEC 61675-1:2022
EN IEC 61675-1:2022 (E)
European foreword
The text of document 62C/811/CDV, future edition 3 of IEC 61675-1, prepared by SC 62C "Equipment
for radiotherapy, nuclear medicine and radiation dosimetry" of IEC/TC 62 "Electrical equipment in
medical practice" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
EN IEC 61675-1:2022.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2023-01-22
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2025-04-22
document have to be withdrawn
This document supersedes EN 61675-1:2014 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 61675-1:2022 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following note has to be added for the standard indicated:
IEC 60601-1:2005 NOTE Harmonized as EN 60601-1:2006 (not modified) +A11:2011
2
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EN IEC 61675-1:2022 (E)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod), the
relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cenelec.eu.
Publication Year Title EN/HD Year
IEC TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
3
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SIST EN IEC 61675-1:2022
IEC 61010-2-012
®
Edition 2.0 2019-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
GROUP SAFETY PUBLICATION
PUBLICATION GROUPÉE DE SÉCURITÉ
Safety requirements for electrical equipment for measurement, control, and
laboratory use –
Part 2-012: Particular requirements for climatic and environmental testing and
other temperature conditioning equipment
Règles de sécurité pour appareils électriques de mesurage, de régulation et de
laboratoire –
Partie 2-012: Exigences particulières pour les appareils d'essais climatiques et
d'environnement, et autres appareils de conditionnement de température
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 19.080 ISBN 978-2-8322-6713-4
Warning! Make sure that you obtained this publication from an authorized distributor.
Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
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CONTENTS
FOREWORD . 4
INTRODUCTION . 7
1 Scope and object . 10
2 Normative references . 11
3 Terms and definitions . 11
4 Tests . 17
5 Marking and documentation . 23
6 Protection against electric shock . 32
7 Protection against mechanical HAZARDS . 34
8 Resistance to mechanical stresses . 36
9 Protection against the spread of fire . 37
10 Equipment temperature limits and resistance to heat . 38
11 Protection against HAZARDS from fluids and solid foreign objects . 42
12 Protection against radiation, including laser sources, and against sonic and
ultrasonic pressure . 57
13 Protection against liberated gases and substances, explosion and implosion . 58
14 Components and subassemblies . 60
15 Protection by interlocks . 62
16 HAZARDS resulting from application . 64
17 RISK assessment . 65
Annexes . 66
Annex K (normative) Insulation requirements not covered by 6.7 . 67
Annex L (informative) Index of defined terms . 68
Annex AA (informative) Useful symbols . 70
Annex BB (informative) Protection of people who are inside WALK-IN EQUIPMENT . 73
Annex CC (informative) Safety requirements for components and piping . 75
Annex DD (informative) Equipment containing FLAMMABLE REFRIGERANTS – Information
and marking requirements. 80
Annex EE (normative) Non-sparking "n" electrical device . 83
Bibliography . 84
Figure 101 – Schema of a REFRIGERATING SYSTEM incorporating a CONDENSER . 8
Figure 102 – Flow chart illustrating the selection process . 9
Figure 103 – Details of scratching TOOL tip . 52
Table 1 – Symbols . 24
Table 101 – Time-temperature conditions . 30
Table 102 – Maximum temperatures for MOTOR-COMPRESSORS . 40
Table 103 – Minimum temperature for the determination of SATURATED-VAPOUR
PRESSURE of the REFRIGERANT . 47
Table 104 – REFRIGERANT flammability parameters . 56
Table AA.1 – Useful symbols . 70
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Table CC.1 – Parameters of pressure vessels according to EN 14276-1 . 76
Table CC.2 – Parameters of piping according to EN 14276-2 . 77
Table CC.3 – Components and piping requirements . 78
Table CC.4 – Minimum wall thickness for copper and steel tubing . 79
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INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT
FOR MEASUREMENT, CONTROL, AND LABORATORY USE –
Part 2-012: Particular requirements for climatic and environmental
testing and other temperature conditioning equipment
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as "IEC
Publication(s)"). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 61010-2-012 has been prepared by IEC technical committee 66:
Safety of measuring, control and laboratory equipment.
It has the status of a group safety publication in accordance with IEC Guide 104.
This second edition cancels and replaces the first edition published in 2016. This edition
constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) alignment with changes introduced by Amendment 1 of IEC 61010-1:2010;
b) changes related to the use of small capitals for defined terms only;
c) clarifications for cooling tests in 4.4.2.10;
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d) requirements for overtemperature protection in 10.101, including deletion of the second
part of the sentence in item b), and the deletion of item c);
e) changes pertaining to the accurate employment of terms "temperature", "operating
temperature", "working temperature", "application temperature", "room temperature" and
"ambient temperature" in 3.5.104, 3.5.105, 4.3.1, 4.3.2, 5.4.2, 8.2.1, 8.2.2, 11.7.2.101.2,
11.7.2.101.3, 13.2.102, 14.102, 15.101, 15.102, 15.103, Introduction and many other
locations. For the purpose of clarification, the definition of 3.5.114, CONTROLLED
TEMPERATURE, is added.
The text of this International Standard is based on the following documents:
FDIS Report on voting
66/687/FDIS 66/688/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.
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.
IEC 61010-2-012 is to be used in conjunction with the latest edition of IEC 61010-1. It was
established on the basis of the third edition (2010) and its Amendment 1 (2016), hereinafter
referred to as Part 1.
This Part 2-012 supplements or modifies the corresponding clauses in IEC 61010-1 so as to
convert that publication into the IEC standard: Particular requirements for climatic and
environmental testing and other temperature conditioning equipment.
Where a particular subclause of Part 1 is not mentioned in this Part 2-012, that subclause
applies as far as is reasonable. Where this Part 2-012 states "addition", "modification",
"replacement", or "deletion", the relevant requirement, test specification, or note in Part 1
should be adapted accordingly.
In this standard:
1) the following print types are used:
– requirements and definitions: in roman type;
– NOTES: in smaller roman type;
– conformity and tests: in italic type;
– terms used throughout this standard which have been defined in Clause 3: SMALL
ROMAN CAPITALS.
2) subclauses, figures, tables and notes which are additional to those in Part 1 are numbered
starting from 101. Additional annexes are lettered starting from AA.
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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 standard using a
colour printer.
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INTRODUCTION
This Part 2-012, along with Part 2-010 and Part 2-011, taken together, address the specific
HAZARDS associated with the heating and cooling of materials by equipment and are organized
as follows:
Specifically addresses the HAZARDS associated with equipment incorporating heating
IEC 61010-2-010
systems.
Specifically addresses the HAZARDS associated with equipment incorporating REFRIGERATING
IEC 61010-2-011
SYSTEMS.
Specifically addresses the HAZARDS associated with equipment incorporating both heating
and REFRIGERATING SYSTEMS that interact with each other such that the combined heating
and REFRIGERATING SYSTEM yield additional or more severe HAZARDS for the two systems
IEC 61010-2-012
than if treated separately. It also addresses the HAZARDS associated with the treatment of
materials by other factors like irradiation, excessive humidity, CO and MECHANICAL
2
MOVEMENT, etc.
Guidance for the application of the appropriate Part 2 standard(s)
When the equipment includes only a material heating system, and no REFRIGERATING SYSTEM
or other environmental factors apply, then Part 2-010 applies without needing Part 2-011 or
REFRIGERATING SYSTEM, and no
Part 2-012. Similarly, when the equipment includes only a
material heating system or other environmental factors apply, then Part 2-011 applies without
needing Part 2-010 or Part 2-012. However, when the equipment incorporates both a material
heating system, and a REFRIGERATING SYSTEM or the materials being treated in the intended
application introduce significant heat into the REFRIGERATING SYSTEM, a determination should
be made as to whether the interaction between the two systems will generate additional or
HAZARDS than if the systems were evaluated separately (CONTROLLED
more severe
TEMPERATURE, see flow chart for selection process). If the interaction of the heating and
cooling functions yields no additional or more severe HAZARDS, then both Part 2-010 and
Part 2-011 apply for their respective functions. Conversely, if additional or more severe
HAZARDS result from the combining of the heating and cooling functions, or if the equipment
incorporates additional material treatment factors, then Part 2-012 applies, but not Part 2-010
or Part 2-011.
What HAZARDS are applicable for a REFRIGERATING SYSTEM?
The typical HAZARDS for a REFRIGERATING SYSTEM (see Figure 101) consisting of a MOTOR-
COMPRESSOR, a CONDENSER, an expansion device and an EVAPORATOR include but are not
limited to:
– The maximum temperature of LOW-PRESSURE SIDE (return temperature) to the MOTOR-
COMPRESSOR. A MOTOR-COMPRESSOR incorporates a REFRIGERANT cooled motor and it
should be established that the maximum temperatures of the LOW-PRESSURE SIDE under
RATINGS within the motor.
least favourable condition do not exceed the insulation
– The maximum pressure of LOW-PRESSURE SIDE at the inlet to the MOTOR-COMPRESSOR. The
housing of the MOTOR-COMPRESSOR is exposed to this pressure and so the design RATING
of the MOTOR-COMPRESSOR housing should accommodate the worst-case pressures whilst
providing the correct safety margin for a pressure vessel.
– The maximum temperature of HIGH-PRESSURE SIDE to the CONDENSER. The temperatures of
the HIGH-PRESSURE SIDE under most unfavourable conditions may present a temperature
HAZARD if the OPERATOR is exposed to them or if the electrical insulation is degraded.
– The maximum pressure of HIGH-PRESSURE SIDE at the outlet to the MOTOR-COMPRESSOR.
The REFRIGERANT components downstream of the MOTOR-COMPRESSOR up to the expansion
device are exposed to this pressure and so the design RATING of these components should
accommodate the worst-case pressures whilst providing the appropriate safety margin for
a pressure vessel.
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– The maximum CONTROLLED TEMPERATURES, namely, the SOAKED TEMPERATURE CONDITIONS,
from which the heat is being extracted, may impact the maximum temperature of LOW-
PRESSURE SIDE to the MOTOR-COMPRESSOR as well as present a temperature HAZARD if the
OPERATOR is exposed to them or if the electrical insulation is degraded. Whether this
CONTROLLED TEMPERATURE is derived from an integral heating function of the device or
from the heat dissipated from the material being cooled, the impact under worst case
conditions should be evaluated.
– The current draw of the equipment should be established when including the worst-case
running conditions of the REFRIGERATING SYSTEM including any defrost cycles that may
apply.
The worst-case conditions should be determined for the equipment and will include both the
NORMAL USE conditions as well as the most unfavourable testing results under
least favourable
SINGLE FAULT CONDITIONS.
Figure 101 – Schema of a REFRIGERATING SYSTEM incorporating a CONDENSER
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The selection process is illustrated in the following flow chart (see Figure 102).
Figure 102 – Flow chart illustrating the selection process
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SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT
FOR MEASUREMENT, CONTROL AND LABORATORY USE –
Part 2-012: Particular requirements for climatic and environmental
testing and other temperature conditioning equipment
1 Scope and object
This clause of Part 1 is applicable except as follows:
1.1.1 Equipment included in scope
Replacement:
Replace the second paragraph by the following:
This part of IEC 61010 specifies safety requirements for electrical equipment and its
accessories within the categories a) through c), wherever it is intended to be used, whenever
that equipment incorporates one or more of the following characteristics:
– A REFRIGERATING SYSTEM that is acted on or impacted by an integral heating function such
that the combined heating and REFRIGERATING SYSTEM generates additional and/or more
severe HAZARDS than those for the two systems if treated separately.
– The materials being treated in the intended application introduce significant heat into the
REFRIGERATING SYSTEM, so that the REFRIGERATING SYSTEM in the application yields
additional and/or more severe HAZARDS than those for the REFRIGERATING SYSTEM if
operated at the maximum RATED ambient temperature alone.
– An irradiation function for the materials being treated presenting additional HAZARDS.
– A function to expose the materials being treated to excessive humidity, carbon dioxide,
salt mist, or other substances which can result in additional HAZARDS.
– A function of MECHANICAL MOVEMENT presenting additional HAZARDS.
– Provision for an OPERATOR to walk in to the operating area to load or unload the materials
being treated.
Addition:
Add the following text after the last paragraph:
NOTE 101 Examples of such equipment include environmental testing and plant growth TEST CHAMBERS,
refrigerating CIRCULATORS which incorporate heating, and recirculating coolers for extracting heat.
It is possible that all or part of the equipment falls within the scope of one or more other
Part 2 standards of IEC 61010 as well as within the scope of this standard. In that case, the
requirements of those other Part 2 standards also apply. This document is intended for
application when one or more of the additional HAZARDS described in the above dashed listed
items are introduced. However, when the equipment incorporates only a REFRIGERATING
SYSTEM or only a heating function or a combination of the two without introducing the
additional HAZARDS described in the above list, then IEC 61010-2-011 or IEC 61010-2-010 or
both, as appropriate, apply instead of this Part 2-012.
See further information in the flow chart (Figure 102) for selection process and guidance in
the Introduction.
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NOTE 102 Subclause 3.1.107 and Annex BB provide the definition and requirements for the protection of people
who are inside WALK-IN EQUIPMENT.
1.1.2 Equipment excluded from scope
Addition:
Add the following items after item j):
aa) equipment for the heating, cooling, and ventilation of laboratories;
bb) sterilizing equipment.
1.2 Object
1.2.1 Aspects included in scope
Addition:
Add the following items after item g):
aa) biohazards (see 13.101);
bb) hazardous chemical substances (see 13.102).
2 Normative references
This clause of Part 1 is applicable, except as follows:
Addition:
IEC 60079-15:2010, Explosive atmospheres – Part 15: Equipment protection by type of
protection "n"
IEC 60079-20-1, Explosive atmospheres – Part 20-1: Material characteristics for gas and
vapour classification – Test methods and data
IEC 60335-2-34:2012, Household and similar electrical appliances – Safety – Part 2-34:
Particular requirements for motor-compressors
IEC 60335-2-34:2012/AMD1:2015
IEC 60335-2-34:2012/AMD2:2016
IEC 60950-1:2005, Information technology equipment – Safety – Part 1: General requirements
ISO 7010, Graphical symbols – Safety colours and safety signs – Registered safety signs
(available at https://www.iso.org/obp)
3 Terms and definitions
This clause of Part 1 is applicable except as follows:
3.1 Equipment and states of equipment
Addition:
Add the following new terms and definitions:
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SIST EN IEC 61675-1:2022
– 12 – IEC 61010-2-012:2019 © IEC 2019
3.1.101
BATH
complete device intended for application of CONTROLLED TEMPERATURES to SPECIMENS by
immersion in a temperature
...
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