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

Applies to equipment intended for in vitro diagnostic (IVD) medical purposes. This is used for the examination of specimens, including blood and tissue samples, derived from the human body. The standard also covers self-test IVD medical equipment for use by lay persons.

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: Prescriptions particulières pour les appareils médicaux de diagnostic in vitro (DIV)

S'applique sux apparels médicaux destinés aux applications de diagnostic in vitro (DIV). Les appareils sont destinés à l'examen in vitro de spécimens, y compris les prélèvements de sang et de tissus d'origine humaine. La norme s'applique aussi aux appareils utilisés par un non-initié dans un environnement domestique.

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

General Information

• Status: Withdrawn
• Publication Date: 14-Nov-2002
• Withdrawal Date: 31-Aug-2005
• 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
• Parallel Committee: IEC/TC 66 - IEC_TC_66
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 24-Feb-2020
• Completion Date: 24-Feb-2020
• 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/095 - In vitro diagnostic (prog.)
• Ref Project: SIST EN 61010-2-101:2003 - Safety requirements for electrical equipment for measurement, control, and laboratory use -- Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

Relations

• Replaced By: 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
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2003
9DUQRVWQH]DKWHYH]DHOHNWULþQRRSUHPR]DPHULWYHQDG]RURYDQMHLQODERUDWRULMVNR
XSRUDERGHO3RVHEQH]DKWHYH]DGLDJQRVWLþQRPHGLFLQVNRRSUHPRLQYLWUR
,9'
Safety requirements for electrical equipment for measurement, control, and laboratory
use -- Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
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: Prescriptions particulières pour les appareils médicaux de
diagnostic in vitro (DIV)
Ta slovenski standard je istoveten z: EN 61010-2-101:2002
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 November 2002

ICS 11.040.55 19.080
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 61010-2-101:2002, modified)

Règles de sécurité pour appareils Sicherheitsbestimmungen für elektrische
électriques de mesurage, de régulation Mess-, Steuer-, Regel- und Laborgeräte
et de laboratoire Teil 2-101: Besondere Anforderungen an
Partie 2-101: Prescriptions particulières In-Vitro-Diagnostik-(IVD)-Medizingeräte
pour les appareils médicaux (IEC 61010-2-101:2002, modifiziert)
de diagnostic in vitro (DIV)
(CEI 61010-2-101:2002, modifiée)

This European Standard was approved by CENELEC on 2002-09-01. 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 Central Secretariat 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 Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Czech Republic,
Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta,
Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels

© 2002 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.

Ref. No. EN 61010-2-101:2002 E

Foreword
The text of document 66/261/FDIS, future edition 1 of IEC 61010-2-101, prepared by IEC TC 66,
Safety of measuring, control, and laboratory equipment, together with common modifications prepared
by CLC/SR 66 following deliberations in CLC/BTTF 88-1, was submitted to the Unique Acceptance
Procedure and was approved by CENELEC as EN 61010-2-101 on 2002-09-01.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2003-09-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2005-09-01
This Part 2-101 is to be used in conjunction with EN 61010-1:2001, Safety requirements for electrical
equipment for measurement, control and laboratory use -- Part 1: General requirements.
Consideration may be given to future editions of, or amendments to, EN 61010-1.
This Part 2-101 supplements or modifies the corresponding clauses of EN 61010-1 so as to convert it
into the European Standard: Safety requirements for in vitro diagnostic (IVD) medical equipment.
Where a particular clause or subclause of Part 1 is not mentioned in this Part 2-101, that clause or
subclause applies as far as is reasonable. Where this Part 2-101 states "addition", "modification" or
"replacement", the relevant text of Part 1 is to 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 or figures which are additional to those in Part 1 are numbered starting from 101, the
additional annexes are lettered AA, BB, etc.
Annexes designated "normative" are part of the body of the standard.
Annexes designated "informative" are given for information only.
In this standard, annexes AA and ZA are normative and annex BB is informative.
Annex ZA has been added by CENELEC.
__________
- 3 - EN 61010-2-101:2002
Endorsement notice
The text of the International Standard IEC 61010-2-101:2002 was approved by CENELEC as a
European Standard with agreed common modifications as given below.
COMMON MODIFICATIONS
Contents
For annex BB, replace "(normative)" by "(informative)".
5.4.4 Equipment operation
Add the following new note:
NOTE 4 The requirements of this standard cover safety aspects only. For further requirements on instructions for use, see EN 591
for IVD medical equipment for professional use, EN 592 for self-test IVD medical equipment. Additional guidance on suitable
instructions for self-test IVD medical equipment is given in informative annex BB.
5.4.4.101 Self-test IVD medical equipment
Delete the text of this subclause and replace by "Void".
Annex BB
In the title, replace "(normative)" by "(informative)".
Bibliography
Add the following publications:
EN 591: In vitro diagnostic systems - Requirements for user manuals for in vitro diagnostic
instruments for professional use.
EN 592: In vitro diagnostic systems - Requirements for user manuals for in vitro diagnostic
instruments for home use.
Add the following note for IEC 60073:
NOTE Replaced by IEC 60073:2002, which is harmonized as EN 60073:2002.
____________
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
Addition to annex ZA of EN 61010-1:
Publication Year Title EN/HD Year
ISO 14971 2000 Medical devices – Application of risk management EN ISO 14971 2000
to medical devices + AC 2002
NORME CEI
INTERNATIONALE IEC
61010-2-101
INTERNATIONAL
Première édition
STANDARD
First edition
2002-01
PUBLICATION GROUPÉE DE SÉCURITÉ
GROUPED SAFETY PUBLICATION
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)
Safety requirements for electrical equipment
for measurement, control and laboratory use –
Part 2-101:
Particular requirements for in vitro diagnostic
(IVD) medical equipment
 IEC 2002 Droits de reproduction réservés  Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in
utilisée sous quelque forme que ce soit et par aucun procédé, any form or by any means, electronic or mechanical,
électronique ou mécanique, y compris la photocopie et les including photocopying and microfilm, without permission in
microfilms, sans l'accord écrit de l'éditeur. writing from the publisher.
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Telefax: [phone] e-mail: [e-mail] IEC web site http://www.iec.ch
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S
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Pour prix, voir catalogue en vigueur
For price, see current catalogue

61010-2-101  IEC:2002 – 3 –
CONTENTS
FOREWORD.5
1 Scope and object.9
2 Normative references .11
3 Terms and definitions .11
4 Tests .13
5MARKING and documentation.15
6 Protection against electric shock .23
7 Protection against mechanical HAZARDS.23
8 Mechanical resistance to shock and impact .23
9 Protection against the spread of fire .25
10 Equipment temperature limits and resistance to heat.25
11 Protection against HAZARDS from fluids .25
12 Protection against radiation, including laser sources, and against sonic and
ultrasonic pressure .25
13 Protection against liberated gases, explosion and implosion.27
14 Components .27
15 Protection by interlocks .27
16 Measuring circuits .27
Annex H Index of defined terms.29
Annex AA (normative) Risk management .31
Annex BB (normative) Instructions for use for self-test IVD medical equipment.35
Bibliography.43

61010-2-101  IEC:2002 – 5 –
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 IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of the 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, the IEC publishes International Standards. 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. The 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 the 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 National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical specifications, technical reports or guides and they are accepted by the National
Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. The 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.
This standard has been prepared in close collaboration with Working Group CENELEC
BTTF 88.1.
It has the status of a group safety function, as specified in IEC Guide 104.
The text of this standard is based on the following documents:
FDIS Report on voting
66/261/FDIS 66/271/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 3.
This part 2 is intended to be used in
...