EN IEC 61010-2-101:2022
(Main)Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment
NEW!IEC 61010-2-101:2018 is available as IEC 61010-2-101:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 61010-2-101:2018 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. It has the status of a group safety publication, as specified in IEC Guide 104. This document has been prepared in close collaboration with Working Group CENELEC BTTF 88.1. This third edition cancels and replaces the second edition published in 2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: - adaptation of changes introduced by Amendment 1 of IEC 61010-1; - added tolerance for stability of AC voltage test equipment to Clause 6. This Part 2-101 is intended to be used in conjunction with IEC 61010-1. It was established on the basis of the third edition (2010) and its Amendment 1 (2016).
Sicherheitsbestimmungen für elektrische Mess-, Steuer-, Regel- und Laborgeräte - Teil 2-101: Besondere Anforderungen an In-vitro-Diagnostik (IVD) Medizingeräte
Exigences de sécurité pour appareils électriques de mesurage, de régulation et de laboratoire - Partie 2-101: Exigences particulières pour le matériel médical de diagnostic in vitro (DIV)
NEW!IEC 61010-2-101:2018 est disponible sous forme de IEC 61010-2-101:2018 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.L’IEC 61010-2-101:2018 s’applique aux appareils destinés aux applications médicales de diagnostic in vitro (DIV), y compris aux appareils médicaux d'autotest DIV. Elle a le statut d'une publication groupée de sécurité conformément au Guide IEC 104. Ce document a été élaboré en étroite collaboration avec le groupe de travail CENELEC BTTF 88.1. Cette troisième édition annule et remplace la deuxième édition parue en 2015. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente: - adaptation des modifications introduites par l’Amendement 1 de l’IEC 61010-1; - ajout à l’Article 6 de la tolérance pour la stabilité du matériel d’essai en tension alternative. Cette Partie 2-101 est destinée à être utilisée conjointement avec l’IEC 61010-1. Elle a été établie sur la base de la troisième édition (2010) et de son Amendement 1 (2016).
Varnostne zahteve za električno opremo za meritve, nadzor in laboratorijsko uporabo - 2-101. del: Posebne zahteve za diagnostično in vitro (IVD) medicinsko opremo (IEC 61010-2-101:2018)
Standard EN 61010-2-101:2017 – Varnostne zahteve za električno opremo za meritve, nadzor in laboratorijsko uporabo je razvrščen v naslednje kategorije ICS:
19.080 – Električno in elektronsko preskušanje
71.040.10 – Kemijski laboratoriji. Laboratorijska oprema
11.040.55 – Diagnostična oprema
Standard IEC 61010-2-101:2015 je na voljo kot IEC 61010-2-101:2015 RLV, ki vsebuje mednarodni standard in njegovo različico z revizijami, ki prikazujejo vse spremembe tehnične vsebine v primerjavi s prejšnjo izdajo.
Standard IEC 61010-2-101:2015 se uporablja za opremo, ki je namenjena diagnostični medicinski uporabi in vitro (IVD), vključno z medicinsko opremo IVD za samopreskušanje. Ima status funkcije skupinske varnosti, kot je navedeno v vodilu 104 Mednarodne elektrotehniške komisije. Ta standard je bil pripravljen v tesnem sodelovanju z delovno skupino CENELEC BTTF 88.1. Druga izdaja razveljavlja in nadomešča prvo izdajo, objavljeno leta 2002. V primerjavi s prejšnjo izdajo je tehnična revizija in vključuje naslednje pomembne spremembe iz prejšnje izdaje kot tudi številne druge spremembe:
– oprema iz standarda IEC 61010-2-081 (splošna laboratorijska oprema) je bila izključena s področja uporabe tega dokumenta, kar jo ločuje od opreme iz standarda IEC 61010-2-101;
– posodobitev simbolov za biološko nevarnost in serijo v preglednici 1 v točki 5;
– točki 5 je bila dodana zahteva glede potrošnega materiala znotraj roka uporabe in podatkov o pooblaščenem predstavniku iz navodil za uporabo;
– točki 5 je bila dodana zahteva glede oznak in vrednosti plinov oziroma tekočin;
– točki 5 je bila dodana zahteva za vključitev navodil za UPRAVLJAVCE v zvezi z uporabo potrošnega materiala oziroma ravnanjem v primeru razlitja vzorca, blokadami ali poškodbami znotraj opreme, odlaganjem nevarnih odpadkov, osebno zaščito, postopki za zmanjšanje TVEGANJA v povezavi z vnetljivimi tekočinami, opeklinami, do katerih pride ob stiku s površinami, ter polnjenjem in praznjenjem vzorca oziroma reagentov iz navodil za uporabo;
– točki 5 je bila dodana zahteva za proizvajalca, da zagotovi navodila v zvezi s prevozom, skladiščenjem in odstranitvijo opreme iz uporabe;
– točki 5 je bila dodana zveza s standardom ISO 18113-5 v zvezi z navodili za uporabo medicinske opreme IVD za samopreskušanje;
– točki 7 je bila dodana zahteva glede navodil za vzdrževanje za UPRAVLJAVCE;
– točki 7 so bile dodane zahteve glede območij vzorčenja in polnjenja;
– iz točke 8 je bila izključena oprema, pri kateri je zaradi njene velikosti in teže nenamerno premikanje pri preskusu padca malo verjetno;
– točki 13 je bila dodana zahteva glede označevanja biološke nevarnosti;
– točki 15 je bila dodana zahteva glede zapornih sistemov, ki vsebujejo električne/elektronske ali programirljive komponente;
– točki 16 je bila dodana zveza s standardom o uporabnosti IEC 62366;
– točko 17 so nadomestile zahteve iz standarda ISO 14971 glede ocene TVEGANJA;
– iz točke 5 so bila izbrisana navodila dodatka BB za uporabo medicinske opreme IVD za samopreskušanje in dodan je bil sklic na standard ISO 18113-5.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2023
Nadomešča:
SIST EN 61010-2-101:2017
Varnostne zahteve za električno opremo za meritve, nadzor in laboratorijsko
uporabo - 2-101. del: Posebne zahteve za diagnostično in vitro (IVD) medicinsko
opremo (IEC 61010-2-101:2018)
Safety requirements for electrical equipment for measurement, control, and laboratory
use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment
(IEC 61010-2-101:2018)
Sicherheitsbestimmungen für elektrische Mess-, Steuer-, Regel- und Laborgeräte - Teil 2
-101: Besondere Anforderungen an In-vitro-Diagnostik (IVD) Medizingeräte
(IEC 61010-2-101:2018)
Exigences de sécurité pour appareils électriques de mesurage, de régulation et de
laboratoire - Partie 2-101: Exigences particulières pour le matériel médical de diagnostic
in vitro (DIV) (IEC 61010-2-101:2018)
Ta slovenski standard je istoveten z: EN IEC 61010-2-101:2022
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
19.080 Električno in elektronsko Electrical and electronic
preskušanje testing
71.040.10 Kemijski laboratoriji. Chemical laboratories.
Laboratorijska oprema Laboratory equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN IEC 61010-2-101
NORME EUROPÉENNE
EUROPÄISCHE NORM November 2022
ICS 11.040.55; 19.080 Supersedes EN 61010-2-101:2017
English Version
Safety requirements for electrical equipment for measurement,
control, and laboratory use - Part 2-101: Safety requirements for
in vitro diagnostic (IVD) medical equipment
(IEC 61010-2-101:2018)
Exigences de sécurité pour appareils électriques de Sicherheitsbestimmungen für elektrische Mess-, Steuer-,
mesurage, de régulation et de laboratoire - Partie 2-101: Regel- und Laborgeräte - Teil 2-101: Besondere
Exigences particulières pour le matériel médical de Anforderungen an In-vitro-Diagnostik (IVD) Medizingeräte
diagnostic in vitro (DIV) (IEC 61010-2-101:2018)
(IEC 61010-2-101:2018)
This European Standard was approved by CENELEC on 2022-09-26. 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,
Türkiye 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 61010-2-101:2022 E
European foreword
The text of document 66/644/CDV, future edition 3 of IEC 61010-2-101, prepared by IEC/TC 66
"Safety of measuring, control and laboratory equipment" was submitted to the IEC-CENELEC parallel
vote and approved by CENELEC as EN IEC 61010-2-101:2022.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2023-09-26
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2025-09-26
document have to be withdrawn
This document supersedes EN 61010-2-101:2017 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.
This document has been prepared under a Standardization Request given to CENELEC by the
European Commission and the European Free Trade Association.
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 61010-2-101:2018 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 62061 NOTE Harmonized as EN IEC 62061
IEC 62366-1 NOTE Harmonized as EN 62366-1
ISO 15223-1 NOTE Harmonized as EN ISO 15223-1
IEC 61010-2-101 ®
Edition 3.0 2018-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
GROUP SAFETY PUBLICATION
PUBLICATION GROUPÉE DE SÉCURITÉ
Safety requirements for electrical equipment for measurement, control and
laboratory use –
Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical
equipment
Exigences de sécurité pour appareils électriques de mesurage, de régulation et
de laboratoire –
Partie 2-101: Exigences particulières pour le matériel médical de diagnostic in
vitro (DIV)
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.55; 19.080 ISBN 978-2-8322-6062-3
– 2 – IEC 61010-2-101:2018 © IEC 2018
CONTENTS
FOREWORD . 3
1 Scope and object . 5
2 Normative references. 6
3 Terms and definitions . 6
4 Tests . 6
5 Marking and documentation . 7
6 Protection against electric shock . 11
7 Protection against mechanical HAZARDS . 11
8 Resistance to mechanical stresses . 13
9 Protection against the spread of fire . 13
10 Equipment temperature limits and resistance to heat . 13
11 Protection against HAZARDS from fluids and solid foreign objects . 13
12 Protection against radiation, including laser sources, and against sonic and
ultrasonic pressure . 14
13 Protection against liberated gases and substances, explosion and implosion . 14
14 Components and subassemblies . 14
15 Protection by interlocks . 14
16 HAZARDS resulting from application. 15
17 RISK assessment . 15
Annexes . 15
Annex L (informative) Index of defined terms . 16
Bibliography . 17
Table 1 – Symbols . 8
IEC 61010-2-101:2018 © IEC 2018 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR
MEASUREMENT, CONTROL AND LABORATORY USE –
Part 2-101: Particular requirements for
in vitro diagnostic (IVD) medical 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,
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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
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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 61010-2-101 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.
This document has been prepared in close collaboration with Working Group
CENELEC BTTF 88.1.
This third edition cancels and replaces the second edition published in 2015. This edition
constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
– 4 – IEC 61010-2-101:2018 © IEC 2018
a) adaptation of changes introduced by Amendment 1 of IEC 61010-1;
b) added tolerance for stability of AC voltage test equipment to Clause 6.
The text of this International Standard is based on the following documents:
CDV Report on voting
66/644/CDV 66/669/RVC
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, under the general title: Safety requirements for
electrical equipment for measurement, control, and laboratory use, may be found on the IEC
website.
This Part 2-101 is intended to be used in conjunction with IEC 61010-1. It was established on
the basis of the third edition (2010) and its Amendment 1 (2016).
This Part 2-101 supplements or modifies the corresponding clauses in IEC 61010-1 so as to
convert that publication into the IEC standard: Particular requi
...
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