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
Current Stage
6060 - Document made available
Due Date
24-Feb-2017
Completion Date
24-Feb-2017

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SLOVENSKI STANDARD
SIST EN 61010-2-101:2017
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
SIST EN 61010-2-101:2017 en

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

---------------------- Page: 1 ----------------------
SIST EN 61010-2-101:2017
---------------------- Page: 2 ----------------------
SIST EN 61010-2-101:2017
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
---------------------- Page: 3 ----------------------
SIST EN 61010-2-101:2017
EN 61010-2-101:2017
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.
---------------------- Page: 4 ----------------------
SIST EN 61010-2-101:2017
EN 61010-2-101:2017
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
---------------------- Page: 5 ----------------------
SIST EN 61010-2-101:2017
EN 61010-2-101:2017
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.
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SIST EN 61010-2-101:2017
EN 61010-2-101:2017
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.
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SIST EN 61010-2-101:2017
EN 61010-2-101:2017
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.
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SIST EN 61010-2-101:2017
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

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
---------------------- Page: 9 ----------------------
SIST EN 61010-2-101:2017
– 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 HAZARDS ........................................................................ 12

8 Resistance to mechanical stresses ............................................................................... 14

9 Protection against the spread of fire ............................................................................. 14

10 Equipment temperature limits and resistance to heat .................................................... 14

11 Protection against HAZARDS from fluids ......................................................................... 14

12 Protection against radiation, including laser sources, and against sonic and

ultrasonic pressure ...................................................................................................... 14

13 Protection against liberated gases and substances, explosion and implosion ................ 15

14 Components and subassemblies .................................................................................. 15

15 Protection by interlocks ................................................................................................ 15

16 HAZARDS resulting from application............................................................................... 15

17 RISK assessment ......................................................................................................... 16

Annexes ............................................................................................................................. 16

Annex L (informative) Index of defined terms ...................................................................... 17

Bibliography ....................................................................................................................... 18

Table 1 – Symbols ................................................................................................................ 8

---------------------- Page: 10 ----------------------
SIST EN 61010-2-101:2017
IEC 61010-2-101:2015 © IEC 2015 – 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 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;
---------------------- Page: 11 ----------------------
SIST EN 61010-2-101:2017
– 4 – IEC 61010-2-101:2015 © IEC 2015
• 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.
The text of this standard is based on the following documents:
FDIS Report on voting
66/545/FDIS 66/560/RVD

Full information on the voting for the approval of this standard can be found in the report on

voting indicated in the above table.

This publication 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).

This Part 2-101 supplements or modifies the corresponding clauses in IEC 61010-1 so as to

convert that publication into the IEC standard: Safety 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:
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SIST EN 61010-2-101:2017
IEC 61010-2-101:2015 © IEC 2015 – 5 –
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.

The committee has decided that the contents of this publication will remain unchanged until

the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data

related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
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SIST EN 61010-2-101:2017
– 6 – IEC 61010-2-101:2015 © IEC 2015
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 by the following:

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 IEC 61010 as

well as within the scope of this standard, considerations have to be given to those other part 2 standards.

1.1.2 Equipment excluded from scope
Addition:
Add the following item:

aa) Equipment in the scope of IEC 61010-2-081 unless they are specifically intended by

their manufacturer to be used for in vitro diagnostic examination.
1.2 Object
1.2.1 Aspects included in scope
Addition:
Add two items:
aa) biohazards;
bb) hazardous chemical substances.
---------------------- Page: 14 ----------------------
SIST EN 61010-2-101:2017
IEC 61010-2-101:2015 © IEC 2015 – 7 –
1.2.2 Aspects excluded from scope
Addition:
Add the following 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 relevant standards.

2 Normative references
This clause of Part 1 is applicable except as follows:
Addition:
Add the following references:
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) – In vitro diagnostic instruments for selftesting

ISO 13857, Safety of machinery – Safety distances to prevent hazard zones being reached by

upper and lower limbs
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 terms and definitions:
3.1.101
SAMPLE ZONE

area where OPERATOR access is typically unintended; 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 note:
NOTE 1 This is not the European Community responsible authority.
4 Tests
This clause of Part 1 is applicable:
---------------------- Page: 15 ----------------------
SIST EN 61010-2-101:2017
– 8 – IEC 61010-2-101:2015 © IEC 2015
5 Marking and documentation
This clause of Part 1 is applicable except as follows:
5.1.1 General
Replacement:
Replace the third paragraph by the following:

Letter symbols for quantities and units shall be in accordance with IEC 60027. Internationally

recognized symbols, including those of Table 1, shall be used as far as possible. If other

additional symbols are required, it shall not be possible to confuse them with the

internationally recognized symbols. There are no colour requirements for symbols. Graphic

symbols shall be explained in the documentation.
Table 1 – Symbols
Addition:
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
5.1.2 Identification
Replacement:
Replace the text by the following:
Equipment shall, as a minimum, be marked with the following information:

a) manufacturer’s name or trade mark, and the address. The address shall include at least

the city and country;

NOTE 1 National regulation may require more details on the address than required in a).

b) model number, name, or other means of identifying the equipment;

The following additional information shall be marked on the equipment or packaging or in the

instructions for use:

1) the serial number, for example SN XXXX or alternatively the batch code, preceded by

‘LOT’, using symbol 102 of Table 1;
2) the following information:
---------------------- Page: 16 -----------------
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