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ENTWURF ÖVE/ÖNORM

EN 61010-2-101
Ausgabe: 2012-10-01

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 66/487/CDV)

Hinweis:
Aufgrund von Stellungnahmen kann die endgültige Fassung
dieser ÖVE/ÖNORM vom vorliegenden Entwurf abweichen.
Stellungnahmen (schriftlich) bis 2012-11-01 an den OVE.

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Alle Rechte vorbehalten! Nachdruck oder Ident (IDT) mit FprEN 61010-2-101:2012
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ENTWURF ÖVE/ÖNORM EN 61010-2-101:2012

Erläuterungen zum Entwurf

Die von IEC TC 66 ausgearbeitete Internationale Norm wurde als Entwurf zu einer Europäischen Norm
EN 61010-2-101:2012 den CENELEC-Mitgliedern zur Abstimmung vorgelegt. Im Falle eines positiven
Abstimmungsergebnisses im Sinne der CEN/CENELEC-Regeln wird dieser Entwurf zu einer EN führen.

Wie alle Mitgliedsorganisationen von CENELEC ist der OVE grundsätzlich verpflichtet, Europäische Normen
in das nationale Normenwerk zu übernehmen und entgegenstehende Normen zurückzuziehen.

Der OVE legt hiermit diesen Entwurf eines europäischen Normungsdokumentes der Öffentlichkeit zur
Information und Stellungnahme als ÖVE/ÖNORM-Entwurf vor.

Da eine Übersetzung in die deutsche Sprache zu diesem Zeitpunkt noch nicht vorhanden ist, wird – um die
von CENELEC vorgegebene Einspruchsfrist einzuhalten – die englischsprachige Fassung
des IEC 66/487/CDV zur Information und Stellungnahme vorgelegt.

Interessenten können das gegenständliche Dokument beim Österreichischen Verband für Elektrotechnik
beziehen bzw. in den Text Einsicht nehmen.
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2
ENTWURF ÖVE/ÖNORM

66/487/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
®
PROJET DE COMITÉ POUR VOTE (CDV)
Project number IEC 61010-2-101 Ed 2
Numéro de projet
IEC/TC or SC: 66 Secretariat / Secrétariat
CEI/CE ou SC: United Kingdom
Submitted for parallel voting in Date of circulation Closing date for voting (Voting
CENELEC Date de diffusion mandatory for P-members)
2012-08-03 Date de clôture du vote (Vote
Soumis au vote parallèle au obligatoire pour les membres (P))
CENELEC 2013-01-04
Also of interest to the following committees Supersedes document
Intéresse également les comités suivants Remplace le document
Issued with 66/486/RR
Proposed horizontal standard
Norme horizontale suggérée
Other TC/SCs are requested to indicate their interest, if any, in this CDV to the TC/SC secretary
Les autres CE/SC sont requis d’indiquer leur intérêt, si nécessaire, dans ce CDV à l’intention du secrétaire du CE/SC
Functions concerned
Fonctions concernées
Safety EMC Environment Quality assurance
Sécurité CEM Environnement Assurance qualité
CE DOCUMENT EST TOUJOURS À L'ÉTUDE ET SUSCEPTIBLE DE THIS DOCUMENT IS STILL UNDER STUDY AND SUBJECT TO CHANGE. IT
MODIFICATION. IL NE PEUT SERVIR DE RÉFÉRENCE. SHOULD NOT BE USED FOR REFERENCE PURPOSES.

LES RÉCIPIENDAIRES DU PRÉSENT DOCUMENT SONT INVITÉS À RECIPIENTS OF THIS DOCUMENT ARE INVITED TO SUBMIT, W ITH THEIR
PRÉSENTER, AVEC LEURS OBSERVATIONS, LA NOTIFICATION DES COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF
DROITS DE PROPRIÉTÉ DONT ILS AURAIENT ÉVENTUELLEMENT WHICH THEY ARE AW ARE AND TO PROVIDE SUPPORTING
CONNAISSANCE ET À FOURNIR UNE DOCUMENTATION EXPLICATIVE. DOCUMENTATION.

Titre: Title:
CEI 61010-2-101 Ed 2: Règles de sécurité pour IEC 61010-2-101 Ed 2: Safety requirements for
appareils électriques de mesurage, de régulation electrical equipment for measurement, control
et de laboratoire and laboratory use
Partie 2-101: Prescriptions particulières pour les Part 2-101: Particular requirements for
appareils médicaux de diagnostic in vitro (DIV) laboratory equipment for in vitro diagnostic (IVD)
medical equipment

Note d'introduction Introductory note


This CDV is circulated for a voting period of five
months as it was sent to the French NC for
translation before the implementation of three
months voting period.

ATTENTION ATTENTION
VOTE PARALLÈLE IEC – CENELEC
CEI – CENELEC PARALLEL VOTING
L’attention des Comités nationaux de la CEI, membres du The attention of IEC National Committees, members of
CENELEC, est attirée sur le fait que ce projet de comité CENELEC, is drawn to the fact that this Committee Draft for
pour vote (CDV) de Norme internationale est soumis au Vote (CDV) for an International Standard is submitted for
vote parallèle. parallel voting.
Les membres du CENELEC sont invités à voter via le The CENELEC members are invited to vote through the
système de vote en ligne du CENELEC. CENELEC online voting system.
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Copyright © 2012 International Electrotechnical Commission, IEC. All rights reserved. It is


permitted to download this electronic file, to make a copy and to print out the content for the sole
purpose of preparing National Committee positions. You may not copy or "mirror" the file or
printed version of the document, or any part of it, for any other purpose without permission in
writing from IEC.
ENTWURF ÖVE/ÖNORM

61010-2-101/Ed.2 © IEC(E) –2– 66/487/CDV

CONTENTS
1 Scope and object .............................................................................................................. 6
2 Normative references ....................................................................................................... 7
3 Terms and definitions ....................................................................................................... 7
4 Tests ................................................................................................................................ 7
5 M ARKING and documentation ............................................................................................. 7
6 Protection against electric shock .................................................................................... 12
7 Protection against mechanical HAZARDS .......................................................................... 12
8 Resistance to mechanical stresses ................................................................................. 12
9 Protection against the spread of fire ............................................................................... 13
10 Equipment temperature limits and resistance to heat ...................................................... 13
11 Protection against HAZARDS from fluids ........................................................................... 13
12 Protection against radiation, including laser sources, and against sonic and
ultrasonic pressure ......................................................................................................... 13
14 Components and subassemblies .................................................................................... 14
15 Protection by interlocks .................................................................................................. 14
16 H AZARDS resulting from application ................................................................................. 14
17 R ISK assessment ............................................................................................................ 14
Annex L (informative) Index of defined terms ...................................................................... 15
Annex BB (informative) Instructions for use for self-test IVD medical equipment ................. 16
Bibliography .......................................................................................................................... 21
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ENTWURF ÖVE/ÖNORM

61010-2-101/Ed.2 © IEC(E) –3– 66/487/CDV

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) 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 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 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 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.

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.
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This second edition cancels and replaces the first edition published in 2002. It constitutes a
technical revision.

This edition includes the following significant changes from the first edition, as well as
numerous other changes.
ENTWURF ÖVE/ÖNORM

61010-2-101/Ed.2 © IEC(E) –4– 66/487/CDV

• Excluded IEC 61010-2-081 (general laboratory equipment) from 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 & 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 and burns from
surfaces 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 requirement for OPERATOR maintenance instructions 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 informative reference to Usability standard IEC 62366 to Clause 16.

• Replaced Clause 17 with requirements of ISO 14971 for RISK assessment.

The text of this standard is based on the following documents:

FDIS Report on voting

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). Consideration may be given to future editions of, or
amendments to, IEC 61010-1.

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.
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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.
ENTWURF ÖVE/ÖNORM

61010-2-101/Ed.2 © IEC(E) –5– 66/487/CDV

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, 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 1 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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———————
1 The National Committees are requested to note that for this publication the stability date is 2017
ENTWURF ÖVE/ÖNORM

61010-2-101/Ed.2 © IEC(E) –6– 66/487/CDV

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:

This part 2 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, it will also need to meet the requirements of those other part 2 standards.

1.1.2 Equipment excluded from scope

Addition:

Add the following paragraph:

aa) Products for general laboratory use as defined 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:


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aa) biohazards;
bb) hazardous chemical substances.

1.2.2 Aspects excluded from scope

Addition: