Radionuclide imaging devices - Characteristics and test conditions - Part 1: Positron emission tomographs

IEC 61675-1:2022 specifies terminology and test methods for declaring the characteristics of POSITRON EMISSION TOMOGRAPHS. POSITRON EMISSION TOMOGRAPHS detect the ANNIHILATION RADIATION of positron emitting RADIONUCLIDES by COINCIDENCE DETECTION.

Bildgebende Systeme in der Nuklearmedizin - Merkmale und Prüfbedingungen - Teil 1: Positronen-Emissions-Tomographen

Dispositifs d'imagerie par radionucléides - Caractéristiques et conditions d'essai - Partie 1: Tomographes à émission de positrons

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

Status
Published
Publication Date
28-Apr-2022
Current Stage
6060 - Document made available - Publishing
Start Date
29-Apr-2022
Completion Date
29-Apr-2022

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SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

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
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
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
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

– 2 – IEC 61010-2-012:2019 © IEC 2019
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

IEC 61010-2-012:2019 © IEC 2019 – 3 –
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

– 4 – IEC 61010-2-012:2019 © IEC 2019
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
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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
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
...

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