SIST EN 61010-2-101:2023

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)

This standard EN 61010-2-101:2017 Safety requirements for electrical equipment for measurement, control and laboratory use is classified in these ICS categories:
19.080 Electrical and electronic testing
71.040.10 Chemical laboratories. Laboratory equipment
11.040.55 Diagnostic equipment
IEC 61010-2-101:2015 is available as IEC 61010-2-101:2015 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC 61010-2-101:2015 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 function, as specified in IEC Guide 104. This standard has been prepared in close collaboration with Working Group CENELEC BTTF 88.1. This second edition cancels and replaces the first edition published in 2002. It constitutes a technical revision and includes the following significant changes from the first edition, as well as numerous other changes:
- excluded IEC 61010-2-081 (general laboratory equipment) from the scope. This separates IEC 61010-2-081 and IEC 61010-2-101 equipment;
- updated Biohazard and Lot symbols in Table 1 in Clause 5;
- added requirement for within expiration consumables and authorized representative details in Instructions for Use to Clause 5;
- added requirement for gas or liquid markings and ratings to Clause 5;
- added requirement to include OPERATOR instructions to deal with consumable or sample spills, jams or breakage inside equipment, disposal of hazardous waste, personal protection, RISK reduction procedures relating to flammable liquids, burns from surfaces, and loading and unloading of sample and reagents in Instructions for Use to Clause 5;
- added requirement for manufacturer to provide instructions on equipment transport, storage and removal from use to Clause 5;
- added normative reference ISO 18113-5 for instructions for use of self-test IVD medical equipment in Clause 5;
- added requirement for OPERATOR maintenance instructions to Clause 7;
- added requirements for sample zones and loading zones to Clause 7;
- excluded equipment whose size and weight make unintentional movement unlikely from drop test in Clause 8;
- added requirement for biohazard marking to Clause 13;
- added requirement for interlock systems containing electric/electronic or programmable components to Clause 15;
- added informative reference to Usability standard IEC 62366 to Clause 16;
- replaced Clause 17 with requirements of ISO 14971 for RISK assessment.
- Annex BB Instructions for use for self-testing IVD Medical Equipment deleted and a reference given to ISO 18113-5 in Clause 5.

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)

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

• Status: Published
• Public Enquiry End Date: 15-Feb-2018
• Publication Date: 12-Dec-2022
• ICS: 11.100.10 - In vitro diagnostic test systems
• ICS: 19.080 - Electrical and electronic testing
• ICS: 71.040.10 - Chemical laboratories. Laboratory equipment
• Technical Committee: MOV - Measuring equipment for electromagnetic quantities
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 16-Nov-2022
• Due Date: 21-Jan-2023
• Completion Date: 13-Dec-2022
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices
• Ref Project: EN IEC 61010-2-101:2022 - Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment

Relations

• Replaces: SIST EN 61010-2-101:2017 - Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for laboratory equipment for in vitro diagnostic (IVD) medical equipment (IEC 61010-2-101:2015)
• Effective Date: 15-Nov-2022
• Amended By: SIST EN 61010-2-101:2023/A11:2023 - Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment
• Effective Date: 27-Apr-2021

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 61010-2-101:2023
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
SIST EN 61010-2-101:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 61010-2-101:2023

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SIST EN 61010-2-101:2023


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

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SIST EN 61010-2-101:2023
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

2

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SIST EN 61010-2-101:2023



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




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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SIST EN 61010-2-101:2023
– 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

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SIST EN 61010-2-101:2023
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,
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 61010-2-101 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:

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SIST EN 61010-2-101:2023
– 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 requirements for in vitro diagnostic
(IVD) medical equipment.
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:
1) the following print types are used:
– requirements: in roman type;
– NOTES: in smaller roman type;
– conformity and test: 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 and additional list
items are lettered from aa).
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.

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SIST EN 61010-2-101:2023
IEC 61010-2-101:2018 © IEC 2018 – 5 –
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR
MEASUREMENT, CONTROL AND LABORATORY USE –

Part 2-101: Particular requirements for
in vitro diagnostic (IVD) medical 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 text, except the first paragraph, with the following new text:
This part of IEC 61010 applies to equipment intended for in vitro diagnostic (IVD) medical
purposes, including self-test IVD medical purposes.
IVD medical equipment, whether used alone or in combination, is intended by the
manufacturer to be used in vitro for the examination of specimens, including blood and tissue
samples, derived from the human body, solely or principally for the purpose of providing
information concerning one or more of the following:
• a physiological or pathological state; or
• a congenital abnormality;
• the determination of safety and compatibility with potential recipients;
• the monitoring of therapeutic measures.
Self-test IVD medical equipment is intended by the manufacturer for use by lay persons in a
home environment.
NOTE If all or part of the equipment falls within the scope of one or more other Part 2 standards of the IEC 61010
series as well as within the scope of this document, consideration is given to those other Part 2 standards.
1.1.2 Equipment excluded from scope
Addition:
Add the following new item:
aa) equipment within the scope of IEC 61010-2-081 unless it is specifically intended by the
manufacturer to be used for in vitro diagnostic examination.
1.2 Object
1.2.1 Aspects included in scope
Addition:
Add the following two new items:
aa) biohazards;
bb) hazardous chemical substances.

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SIST EN 61010-2-101:2023
– 6 – IEC 61010-2-101:2018 © IEC 2018
1.2.2 Aspects excluded from scope
Addition:
Add the following new item and note:
aa) the handling or manipulation outside the equipment of material under analysis.
NOTE Requirements covering these subjects are the responsibility of committees preparing the relevant
standards.
2 Normative references
This clause of Part 1 is applicable except as follows:
Addition:
Add the following new references to the list:
ISO 14971, Medical devices – Application of risk management to medical devices
ISO 18113-5, In vitro diagnostic medical devices – Information supplied by the manufacturer
(labelling) – Part 5: In vitro diagnostic instruments for self-testing
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:
3.1.101
SAMPLE ZONE
area where OPERATOR access is typically unintended
Note 1 to entry: The inside of this zone presents mechanical HAZARDS and a more likely probability of
biohazardous human skin puncture.
3.1.102
LOADING ZONE
area of automated equipment where an OPERATOR handles sample or reagent material
3.5.12 RESPONSIBLE BODY
Addition:
Add the following new note:
Note 1 to entry: This is not the European Union's responsible authority.
4 Tests
This clause of Part 1 is applicable.

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SIST EN 61010-2-101:2023
IEC 61010-2-101:2018 © IEC 2018 – 7 –
5 Marking and documentation
This clause of Part 1 is applicable except as follows:
5.1.1 General
Replacement:
Replace the third paragraph with the following new text:
Letter symbols for quantities and units shall be in accordance with IEC 60027 (all parts).
Internationally recognized symbols, including those of Table 1, shall be used as far as
possible. If other additional symbols
...

SLOVENSKI STANDARD
oSIST prEN 61010-2-101:2018
01-februar-2018
9DUQRVWQH]DKWHYH]DHOHNWULþQRRSUHPR]DPHULWYHQDG]RULQODERUDWRULMVNR
XSRUDERGHO3RVHEQH]DKWHYH]DGLDJQRVWLþQRLQYLWUR,9'PHGLFLQVNR
RSUHPR,(&;(49
Safety requirements for electrical equipment for measurement, control, and laboratory
use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment IEC
61010-2-101:201X (EQV)
Ta slovenski standard je istoveten z: prEN 61010-2-101:2017
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
19.080 (OHNWULþQRLQHOHNWURQVNR Electrical and electronic
SUHVNXãDQMH testing
oSIST prEN 61010-2-101:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 61010-2-101:2018

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oSIST prEN 61010-2-101:2018
66/644/CDV

COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 61010-2-101 ED3
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2017-12-01 2018-02-23
SUPERSEDES DOCUMENTS:
66/630A/RR

IEC TC 66 : SAFETY OF MEASURING, CONTROL AND LABORATORY EQUIPMENT
SECRETARIAT: SECRETARY:
United Kingdom Mr David Hyde
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:


Other TC/SCs are requested to indicate their interest, if
any, in this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY

SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft
for Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.

This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of
which they are aware and to provide supporting documentation.

TITLE:
Safety requirements for electrical equipment for measurement, control, and laboratory use – Part
2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment

NOTE FROM TC/SC OFFICERS:
This CDV is intended only to align IEC 61010-2-101:2015 with IEC 61010-1:2010 and its amendment
1:2016. A revision this soon is justified by the large number of significant changes introduced by this
amendment 1. With this revision IEC 61010-2-101 will be in line with the latest requirements of IEC
61010-1 + A1.
Copyright © 2017 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to
download this electronic file, to make a copy and to print out the content for the sole purpose of preparing National
Committee positions. You may not copy or "mirror" the file or printed version of the document, or any part of it, for
any other purpose without permission in writing from IEC.

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This document contains no technical changes to already accepted base documents (IEC 61010-1:2010
and its amendment 1:2016 and IEC 61010-2-101:2015) but one; Clause 6.8.3.1 is modified because
otherwise it would need a specific European deviation in order to be harmonised to the LVD
2014/35/EU (ref. NAC assessment of IEC 61010-1/A1). Further technical development is reserved for a
new amendment or edition to be initiated separately as necessary.
This alignment is realised as a new 3rd edition of IEC 61010-2-101 simply because of document
control; the previous edition 2.0 is based on the third edition of IEC 61010-1:2010 (without the
Amendment 1:2016) and amending it to incorporate the contents of IEC 61010-1 Amendment 1 would
need an unnecessary repeating of the requirements in that amendment 1 that are not particular for the
equipment in the scope of IEC 61010-2-101. Furthermore, technically, one would need to follow 4
documents in parallel to get the full text of this part 2 (61010-1:2010, 61010-1 A1:2016, 61010-2-
101:2015, and 61010-2-101 A1).With this approach, and when the consolidated version of IEC 61010-
1:2010/A1:2016 conveniently is published, only two documents are needed.

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1 CONTENTS
2 FOREWORD . 3
3 1 Scope and object . 5
4 2 Normative references. 6
5 3 Terms and definitions . 6
6 4 Tests . 7
7 5 Marking and documentation . 7
8 6 Protection against electric shock . 11
9 7 Protection against mechanical HAZARDS . 12
10 8 Resistance to mechanical stresses . 13
11 9 Protection against the spread of fire . 14
12 10 Equipment temperature limits and resistance to heat . 14
13 11 Protection against HAZARDS from fluids . 14
14 12 Protection against radiation, including laser sources, and against sonic and
15 ultrasonic pressure . 14
16 13 Protection against liberated gases and substances, explosion and implosion . 14
17 14 Components and subassemblies . 14
18 15 Protection by interlocks . 15
19 16 HAZARDS resulting from application. 15
20 17 RISK assessment . 15
21 Annexes . 15
22 Annex L (informative) Index of defined terms . 16
23 Bibliography . 17
24
25 Table 1 – Symbols . 7
26
27

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28 INTERNATIONAL ELECTROTECHNICAL COMMISSION
29 ____________
30
31 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT
32 FOR MEASUREMENT, CONTROL AND LABORATORY USE –
33
34 Part 2-101: Particular requirements for
35 in vitro diagnostic (IVD) medical equipment
36
37 FOREWORD
38 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
39 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
40 international co-operation on all questions concerning standardization in the electrical and electronic fields. To
41 this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
42 Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
43 Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
44 in the subject dealt with may participate in this preparatory work. International, governmental and non-
45 governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
46 with the International Organization for Standardization (ISO) in accordance with conditions determined by
47 agreement between the two organizations.
48 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
49 consensus of opinion on the relevant subjects since each technical committee has representation from all
50 interested IEC National Committees.
51 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
52 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
53 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
54 misinterpretation by any end user.
55 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
56 transparently to the maximum extent possible in their national and regional publications. Any divergence
57 between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
58 the latter.
59 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
60 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
61 services carried out by independent certification bodies.
62 6) All users should ensure that they have the latest edition of this publication.
63 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
64 members of its technical committees and IEC National Committees for any personal injury, property damage or
65 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
66 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
67 Publications.
68 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
69 indispensable for the correct application of this publication.
70 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
71 patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
72 International Standard IEC 61010-2-101 has been prepared by IEC technical committee 66:
73 Safety of measuring, control and laboratory equipment.
74 It has the status of a group safety publication, as specified in IEC Guide 104.
75 This standard has been prepared in close collaboration with Working Group CENELEC
76 BTTF 88.1.
77 This second third edition cancels and replaces the first second edition published in 201502. It
78 constitutes a technical revision and includes the following significant changes from the first
79 second edition, as well as numerous othera few editorial changes:
80 • adaptation of changes introduced by Amendment 1 of IEC 61010-1;

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81 • added tolerance for stability of a.c. voltage test equipment to Clause 6.
82 • .
83 The text of this standard is based on the following documents:
FDIS Report on voting
66/xxx/FDIS 66/xxx/RVD
84
85 Full information on the voting for the approval of this standard can be found in the report on
86 voting indicated in the above table.
87 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
88 A list of all parts of the IEC 61010 series, under the general title: Safety requirements for
89 electrical equipment for measurement, control, and laboratory use, may be found on the IEC
90 website.
91 This Part 2-101 is intended to be used in conjunction with IEC 61010-1. It was established on
92 the basis of the third edition (2010) and its Amendment 1 (2016). This Part 2-101 supplements
93 or modifies the corresponding clauses in IEC 61010-1 so as to convert that publication into
94 the IEC standard: Safety requirements for in vitro diagnostic (IVD) medical equipment.
95 Where a particular subclause of Part 1 is not mentioned in this Part 2, that subclause applies
96 as far as is reasonable. Where this part states “addition”, “modification”, “replacement”, or
97 “deletion” the relevant requirement, test specification or note in Part 1 should be adapted
98 accordingly.
99 In this standard:
100 1) the following print types are used:
101 – requirements: in roman type;
102 – NOTES: in smaller roman type;
103 – conformity and test: in italic type;
104 – terms used throughout this standard which have been defined in clause 3: SMALL
105 ROMAN CAPITALS;
106 2) subclauses, figures, tables and notes which are additional to those in part 1 are numbered
107 starting from 101. Additional annexes are lettered starting from AA.
108 The committee has decided that the contents of this publication will remain unchanged until
109 the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data
110 related to the specific publication. At this date, the publication will be
111 • reconfirmed,
112 • withdrawn,
113 • replaced by a revised edition, or
114 • amended.
115
116

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117 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT
118 FOR MEASUREMENT, CONTROL AND LABORATORY USE –
119
120 Part 2-101: Particular requirements for
121 in vitro diagnostic (IVD) medical equipment
122
123
124
125 1 Scope and object
126 This clause of Part 1 is applicable except as follows:
127 1.1.1 Equipment included in scope
128 Replacement:
129 Replace the text by the following:
130 This part of IEC 61010 applies to equipment intended for in vitro diagnostic (IVD) medical
131 purposes, including self-test IVD medical purposes.
132 IVD medical equipment, whether used alone or in combination, is intended by the
133 manufacturer to be used in vitro for the examination of specimens, including blood and tissue
134 samples, derived from the human body, solely or principally for the purpose of providing
135 information concerning one or more of the following:
136 • a physiological or pathological state; or
137 • a congenital abnormality;
138 • the determination of safety and compatibility with potential recipients;
139 • the monitoring of therapeutic measures.
140 Self-test IVD medical equipment is intended by the manufacturer for use by lay persons in a
141 home environment.
142 NOTE If all or part of the equipment falls within the scope of one or more other part 2 standards of IEC 61010 as
143 well as within the scope of this standard, considerations have to be given to those other part 2 standards.
144 1.1.2 Equipment excluded from scope
145 Addition:
146 Add the following item:
147 aa) Equipment in the scope of IEC 61010-2-081 unless they are specifically intended by
148 their manufacturer to be used for in vitro diagnostic examination.
149 1.2 Object
150 1.2.1 Aspects included in scope
151 Addition:
152 Add two items:
153 aa) biohazards;
154 bb) hazardous chemical substances.

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155 1.2.2 Aspects excluded from scope
156 Addition:
157 Add the following item and note:
158 aa) the handling or manipulation outside the equipment of material under analysis.
159 NOTE Requirements covering these subjects are the responsibility of committees preparing relevant standards.
160 2 Normative references
161 This clause of Part 1 is applicable except as follows:
162 Addition:
163 Add the following references:
164 IEC 62061, Safety of machinery – Functional safety of safety-related electrical, electronic and
165 programmable electronic control systems
166 ISO 14971, Medical devices – Application of risk management to medical devices
167 ISO 18113-5, In vitro diagnostic medical devices – Information supplied by the manufacturer
168 (labelling) – In vitro diagnostic instruments for selftesting
169 ISO 13849 (all parts), Safety of machinery – Safety-related parts of control systems
170 ISO 13857, Safety of machinery – Safety distances to prevent hazard zones being reached by
171 upper and lower limbs
172 3 Terms and definitions
173 This clause of Part 1 is applicable except as follows:
174 3.1 Equipment and states of equipment
175 Addition:
176 Add the following terms and definitions:
177 3.1.101
178 SAMPLE ZONE
179 area where OPERATOR access is typically unintended; the inside of this zone presents
180 mechanical HAZARDS and a more likely probability of biohazardous human skin puncture
181 3.1.102
182 LOADING ZONE
183 area of automated equipment where an OPERATOR handles sample or reagent material.
184 3.5.12 RESPONSIBLE BODY
185 Addition:
186 Add the following note:

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187 NOTE 1 This is not the European Community responsible authority.
188 4 Tests
189 This clause of Part 1 is applicable.:
190 5 Marking and documentation
191 This clause of Part 1 is applicable except as follows:
192 5.1.1 General
193 Replacement:
194 Replace the third paragraph by the following:
195 Letter symbols for quantities and units shall be in accordance with IEC 60027. Internationally
196 recognized symbols, including those of Table 1, shall be used as far as possible. If other
197 additional symbols are required, it shall not be possible to confuse them with the
198 internationally recognized symbols. There are no colour requirements for symbols. Graphic
199 symbols shall be explained in the documentation.
200 Table 1 – Symbols
201 Addition:
202 Add the following symbols to Table 1:
Number Symbol Publication Description
Background colour
– optional;
Symbol colour
101 ISO 7000- 0659 (2004-01) Biological RISKS
– optional;
Outline / outline colour
– optional;

102 ISO 7000- 2492 (2004-01) Batch code

203
204 5.1.2 Identification
205 Replacement:
206 Replace the text by the following:
207 Equipment shall, as a minimum, be marked with the following information:
208 a) manufacturer’s name or trade mark, and the address. The address shall include at least
209 the city and country;
210 NOTE 1 National regulation may require more details on the address than required in a).
211 b) model number, name, or other means of identifying the equipment;

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212 The following additional information shall be marked on the equipment or packaging or in the
213 instructions for use:
214 1) the serial number, for example SN XXXX or alternatively th
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