EN 61010-2-101:2017

SLOVENSKI STANDARD
01-julij-2017
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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)
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Règles de sécurité pour appareils électriques de mesurage, de régulation et de
laboratoire - Partie 2-101: Prescriptions particulières pour les appareils médicaux de
diagnostic in vitro (DIV) (IEC 61010-2-101:2015)
Ta slovenski standard je istoveten z: EN 61010-2-101:2017
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
19.080 (OHNWULþQRLQHOHNWURQVNR Electrical and electronic
SUHVNXãDQMH 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 61010-2-101

NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2017
ICS 11.040.55; 19.080 Supersedes EN 61010-2-101:2002
English Version
Safety requirements for electrical equipment for measurement,
control and laboratory use - Part 2-101: Particular requirements
for in vitro diagnostic (IVD) medical equipment
(IEC 61010-2-101:2015)
Règles de sécurité pour appareils électriques de mesurage, Sicherheitsbestimmungen für elektrische Mess-, Steuer-,
de régulation et de laboratoire - Partie 2-101: Exigences Regel- und Laborgeräte - Teil 2-101: Besondere
particulières pour les appareils médicaux de diagnostic in Anforderungen an In-vitro-Diagnostik (IVD)-Medizingeräte
vitro (DIV) (IEC 61010-2-101:2015)
(IEC 61010-2-101:2015)
This European Standard was approved by CENELEC on 2015-02-27. 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, 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: Avenue Marnix 17, B-1000 Brussels
© 2017 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 61010-2-101:2017 E

European foreword
The text of document 66/545/FDIS, future edition 2 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 61010-2-101:2017.
The following dates are fixed:
(dop) 2017-08-24
• latest date by which the document has to be implemented at
national level by publication of an identical national
standard or by endorsement
(dow) 2020-02-24
• latest date by which the national standards conflicting with
the document have to be withdrawn

This document supersedes EN 61010-2-101:2002.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive(s) see informative Annex ZZ, which is an integral part of this
document.
Endorsement notice
The text of the International Standard IEC 61010-2-101:2015 was approved by CENELEC as a
European Standard without any modification.
The Bibliography of EN 61010-1:2010 is applicable except as follows:
In the bibliography of EN 61010-1:2010, the following note has to be added for the standard indicated:
ISO 15223-1 NOTE Harmonized as EN ISO 15223-1.
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 When 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.

Annex ZA of EN 61010-1:2010 is applicable, except as follows:
Publication Year Title EN/HD Year
Addition:
ISO 13857 -  Safety of machinery - Safety distances EN ISO 13857 -
to prevent hazard zones being reached
by upper and lower limbs
ISO 14971 -  Medical devices - Application of risk EN ISO 14971 -
management to medical devices
ISO 18113-5 -  In vitro diagnostic medical devices - EN ISO 18113-5 -
Information supplied by the
manufacturer (labelling) - Part 5: In vitro
diagnostic instruments for self-testing

Annex ZZ
(informative)
Relationship between this European Standard and the essential requirements
of Directive 98/79/EC [OJ L 331] aimed to be covered
This European Standard has been prepared under a Commission’s standardisation request, M/252,
concerning the development of European Standards relating to in vitro diagnostic medical devices, to
provide one voluntary means of conforming to essential requirements of Directive 98/79/EC of the
European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
[OJ L 331].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative clauses of this standard given in Table ZZ.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding essential requirements
of that Directive, and associated EFTA regulations.
NOTE 1 This standard is intended to be applied in its entirety only. Selected clauses or subclauses may be not
applicable due to the specific type of equipment under consideration. It is necessary to understand and apply
Clauses 1 to 4. It is also recommended to understand and apply those clauses which contain general
requirements related to a specific subclause. Elements of the standard that are not cited in Table ZZ.1 may be
relevant for the appropriate fulfilment of certain essential requirements through indirect reference, and for safety
and performance aspects of the device, that are not addressed through essential requirements.
NOTE 2 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 98/79/EC. This means that risks have to be
reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’, according to
the wording of the corresponding essential requirement.
NOTE 3 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements Part A: 1, 2 and 5; Part B: 1.2, 2, 3, 5, 6 and 7 of the Directive.
NOTE 4 This Annex ZZ is based on normative references according to Annex ZA, replacing the references in
the core text.
NOTE 5 When an Essential Requirement does not appear in Table ZZ.1, it means that it is not addressed by
this European Standard.
Table ZZ.1 – Correspondence between this European Standard and
Annex I of Directive 98/79/EC [OJ L 331]
Essential Clause(s) / Remarks / Notes
Requirements of sub-clause(s)
Directive 98/79/EC of this EN
A GENERAL REQUIREMENTS
1 Clauses 6 to 13, Fully covered for the hazards identified in Clauses 6
Clause 17 to 13.
Clause 17 covers hazards and risks not addressed
by the clauses above. See especially Note 2 above.
2 Clauses 6 to 16, Covered.
Clause 17
Clause 17 by applying EN ISO 14971.
B DESIGN AND MANUFACTURING REQUIREMENTS
1.2 5.4.102, 8.101, Partially covered.
Clause 13
Special design considerations for transport and
storage are not addressed.
2.1 7.3.1, 7.3.3, Partially covered.
7.3.101,
This safety standard does not address the risks in
Clause 11, 13.101
device manufacturing processes.
and Clause 17
3.1 5.4.6, 6.6.1, 6.6.2 Partially covered with respect to the effects of the
device being assessed to the safety of a
combination. This safety standard does not address
performance of a device.
3.2 Clause 11, Covered.
Clause 13
3.3 indent one 7.4, 7.5, 11.7, 16.2 Covered.
3.3 indent two Clause 8, 10.5, Partially covered with respect to mechanical and
11.3, 11.6 temperature effects and penetration of substances.
3.4 Clause 9 and 13.2 Covered.
3.5 5.4.101 Covered.
3.6 16.2 Partially covered with respect to hazards.
5.1 Clause 12 Covered.
5.3 5.4.3 j) Partially covered with respect to protective
measures.
6.3 Clause 6 Covered.
6.4.1 Clause 7, Partially covered.
Clause 13 and
Third paragraph requirements are not specifically
Clause 15
addressed.
6.4.3 12.5 Covered.
6.4.4 5.1.5, 6.10, 6.11 Covered.
and 13.101
6.4.5 10.1 Covered.
8.1 Clause 5 Partially covered with respect to safe use of the
device.
Essential Clause(s) / Remarks / Notes
Requirements of sub-clause(s)
Directive 98/79/EC of this EN
8.2 5.1.1 Covered.
8.4 (a) 5.1.2 a) Partially covered.
This standard does not address the specifics of
imported devices (authorized representative).
8.4 (b) 5.1.2 b) Partially covered.
Limited to details related to the identification of the
device.
8.4 (d) 5.1.2 1) Covered.
8.4 (g) 5.1.2 2) i) Covered.
8.4 (h) 5.1.101 Partially covered.
Particular conditions for handling are not addressed.
8.4 (j) 5.2 Covered.
8.4 (k) 5.1.2 2) ii) Covered.
8.5 5.4.1 Partially covered.
Requirements for the label are not addressed.
8.6 5.1.2 1), Covered.
5.1.2 2) iii)
8.7 (a) Partially covered.
Referring to:
8.4 (a) 5.4.1 c) This standard does not address the specifics of
imported devices (authorized representative).

8.4 (h) 5.4.102, 5.4.4 i) Covered.
8.4 (i) 5.4.4 Covered.
8.4 (j) 5.4.3, 5.4.4 Covered.
8.7 (s) 5.4.101 and Covered
13.101
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the product(s) falling within the scope of
this standard.
IEC 61010-2-101 ®
Edition 2.0 2015-01
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
Règles de sécurité pour appareils électriques de mesurage, de régulation et de

laboratoire –
Partie 2-101: Exigences particulières pour les appareils médicaux de diagnostic

in vitro (DIV)
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.55, 19.080 ISBN 978-2-8322-2206-5

– 2 – IEC 61010-2-101:2015 © IEC 2015
CONTENTS
FOREWORD . 3
1 Scope and object . 6
2 Normative references. 7
3 Terms and definitions . 7
4 Tests . 7
5 Marking and documentation . 8
6 Protection against electric shock . 12
7 Protection against mechanical HAZAR
...