IEC 61010-2-101:2015
(Main)Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
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.
This publication is to be read in conjunction with IEC 61010-1:2010.
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)
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.
Cette publication doit être lue conjointement avec la CEI 61010-1:2010.
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IEC 61010-2-101 ®
Edition 2.0 2015-01
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
GROUP SAFETY PUBLICATION
Safety requirements for electrical equipment for measurement, control and
laboratory use –
Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical
equipment
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
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About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
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and withdrawn publications. have been collected from earlier publications of IEC TC 37,
77, 86 and CISPR.
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IEC 61010-2-101 ®
Edition 2.0 2015-01
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
GROUP SAFETY PUBLICATION
Safety requirements for electrical equipment for measurement, control and
laboratory use –
Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical
equipment
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.55, 19.080 ISBN 978-2-8322-2242-3
– 2 – IEC 61010-2-101:2015 RLV © IEC 2015
CONTENTS
FOREWORD . 3
1 Scope and object . 6
2 Normative references . 7
3 Terms and definitions . 7
4 Tests . 9
5 Marking and documentation . 9
6 Protection against electric shock . 14
7 Protection against mechanical HAZARDS . 14
8 Mechanical resistance to shock and impact Resistance to mechanical stresses . 16
9 Protection against the spread of fire . 17
10 Equipment temperature limits and resistance to heat . 17
11 Protection against HAZARDS from fluids . 17
12 Protection against radiation, including laser sources, and against sonic and
ultrasonic pressure . 17
13 Protection against liberated gases and substances, explosion and implosion . 17
14 Components and subassemblies . 18
15 Protection by interlocks . 18
16 Measuring circuits HAZARDS resulting from application . 19
17 RISK assessment . 19
Annexes . 19
Annex H L (informative) Index of defined terms . 19
Annex AA (normative) Risk management .
Annex BB (normative) Instructions for use for self-test IVD medical equipment .
Bibliography . 26
Table 1 – Symbols . 9
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
This redline version of the official IEC Standard allows the user to identify the changes
made to the previous edition. A vertical bar appears in the margin wherever a change
has been made. Additions are in green text, deletions are in strikethrough red text.
– 4 – IEC 61010-2-101:2015 RLV © IEC 2015
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;
• 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:
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
...
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)
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.
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ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie
et les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des
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les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.
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Switzerland www.iec.ch
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.
IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
The stand-alone application for consulting the entire The world's leading online dictionary of electronic and
bibliographical information on IEC International Standards, electrical terms containing more than 30 000 terms and
Technical Specifications, Technical Reports and other definitions in English and French, with equivalent terms in 15
documents. Available for PC, Mac OS, Android Tablets and additional languages. Also known as the International
iPad. Electrotechnical Vocabulary (IEV) online.
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The advanced search enables to find IEC publications by a More than 60 000 electrotechnical terminology entries in
variety of criteria (reference number, text, technical English and French extracted from the Terms and Definitions
committee,…). It also gives information on projects, replaced clause of IEC publications issued since 2002. Some entries
and withdrawn publications. have been collected from earlier publications of IEC TC 37,
77, 86 and CISPR.
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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 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
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;
– 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
...
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