EN 61010-2-101:2017

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 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

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)

L'IEC 61010-2-101:2015 s'applique aux appareils destinés aux applications médicales de diagnostic in vitro (DIV), y compris aux appareils médicaux d'autodiagnostic DIV. Cette norme a le statut de publication groupée de sécurité, conformément au Guide 104 de l'IEC. La préparation de cette norme a été réalisée en étroite collaboration avec le groupe de travail CENELEC BTTF 88.1. Cette deuxième édition annule et remplace la première édition parue en 2002. Cette édition constitue une révision technique et inclut les modifications techniques majeures suivantes par rapport à la première édition, ainsi que de nombreuses autres modifications: - exclusion de l'IEC 61010-2-081 (appareils d'usage général de laboratoire) du domaine d'application, ce qui distingue les appareils de l'IEC 61010-2-081 et ceux de l'IEC 61010-2-101; - mise à jour des symboles Danger biologique et Lot dans le Tableau 1 à l'Article 5; - ajout d'une exigence relative aux consommables possédant une date d'expiration et aux informations concernant le représentant autorisé dans les Instructions d'utilisation à l'Article 5; - ajout d'une exigence relative aux marquages et caractéristiques assignées des gaz et liquides à l'Article 5; - ajout d'une exigence incluant des instructions à l'OPÉRATEUR permettant de couvrir les déversements, bourrages ou bris de consommables ou de prélèvements à l'intérieur des appareils, l'élimination des déchets dangereux, la protection individuelle, les procédures de réduction de RISQUE applicables aux liquides inflammables, brûlures causées par des surfaces, ainsi que le chargement et le déchargement de prélèvements et de réactifs dans les Instructions d'utilisation à l'Article 5; - ajout d'une exigence imposant au fabricant de fournir des instructions relatives au transport, au stockage et au retrait d'utilisation des appareils à l'Article 5; - ajout de la référence normative ISO 18113-5 relative aux instructions d'utilisation des appareils médicaux d'autodiagnostic DIV à l'Article 5; - ajout d'exigences relatives aux instructions d'entretien par l'OPÉRATEUR à l'Article 7; - ajout d'exigences relatives aux zones de prélèvement et aux zones de chargement à l'Article 7; - exclusion des appareils dont la taille et le poids rendent improbable un mouvement involontaire de l'essai de chute à l'Article 8; - ajout d'une exigence relative au marquage des dangers biologiques à l'Article 13; - ajout d'une exigence relative aux systèmes de verrouillage incluant des composants électriques/électroniques ou programmables à l'Article 15; - ajout d'une référence informative à la Norme d'aptitude à l'utilisation IEC 62366 à l'Article 16; - remplacement de l'Article 17 par les exigences de l'ISO 14971 concernant l'évaluation du RISQUE. - suppression des instructions d'utilisation de l'Annexe BB relatives aux appareils médicaux d'autodiagnostic DIV et ajout d'une référence à l'ISO 18113-5 à l'Article 5.

Varnostne zahteve za električno opremo za meritve, nadzor in laboratorijsko uporabo - 2-101. del: Posebne zahteve za diagnostično medicinsko opremo in vitro (IVD) (IEC 61010-2-101:2015)

Ta standard se uporablja za opremo, ki je namenjena diagnostični medicinski uporabi in vitro (IVD), vključno z medicinsko opremo IVD za samopreskušanje. Medicinska oprema IVD, ki jo je proizvajalec predvidel za uporabo, samostojno ali v kombinaciji, in vitro za preiskavo vzorcev, vključno z vzorci krvi in tkiv, iz človeškega telesa izključno ali zlasti z namenom pridobiti podatke, ki se nanašajo na eno ali več naslednjih stvari: – psihološko ali patološko stanje; ali – prirojeno anomalijo; – ugotavljanje varnosti in združljivosti z morebitnimi prejemniki; – spremljanje terapevtskih ukrepov. Medicinsko opremo IVD za samopreskušanje je proizvajalec predvidel za uporabo s strani nestrokovnih oseb v domačem okolju.

General Information

• Status: Published
• Publication Date: 23-Feb-2017
• ICS: 11.040.55 - Diagnostic equipment
• ICS: 19.080 - Electrical and electronic testing
• Technical Committee: CLC/TC 66X - Safety of measuring, control, and laboratory equipment
• Drafting Committee: IEC/TC 66 - IEC_TC_66
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 24-Feb-2017
• Completion Date: 24-Feb-2017
• 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: 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)

Relations

• Replaces: EN 61010-2-101:2002 - Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
• Effective Date: 28-Jan-2023
• Replaced By: 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
• Effective Date: 23-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2017
9DUQRVWQH]DKWHYH]DHOHNWULþQRRSUHPR]DPHULWYHQDG]RULQODERUDWRULMVNR
XSRUDERGHO3RVHEQH]DKWHYH]DGLDJQRVWLþQRPHGLFLQVNRRSUHPRLQYLWUR
,9',(&
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)
6LFKHUKHLWVEHVWLPPXQJHQIUHOHNWULVFKH0HVV6WHXHU5HJHOXQG/DERUJHUlWH7HLO
%HVRQGHUH$QIRUGHUXQJHQDQ,QYLWUR'LDJQRVWLN,9'0HGL]LQJHUlWH
,(&
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
...