EN 61010-2-101:2002

SLOVENSKI STANDARD
01-marec-2003
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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
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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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International Electrotechnical Commission
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 conjunction with IEC 61010-1. It was established on the
basis of the second edition (2001). Consideration may be given to future editions of, or
amendments to, IEC 61010-1.
61010-2-101  IEC:2002 – 7 –
This part 2 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 or figures which are additional to those in part 1 are numbered starting from
101; the additional annexes are lettered AA and BB.
Annexes AA and BB form integral parts of this standard.
The committee has decided that the contents of this publication remain valid until 2004-12. At
this date, in accordance with the committee’s decision, the publication will be:
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
61010-2-101  IEC:2002 – 9 –
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 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 second paragraph:
Products for general laboratory use are not IVD medical devices unless such products, in
view of their characteristics, are specifically intended by their manufacturer to be used for in
vitro diagnostic examination.
61010-2-101  IEC:2002 – 11 –
1.2 Object
1.2.1 Aspects included in scope
Replacement:
Replace the first sentence by the following:
The purpose of the requirements of this standard is to ensure that the design and the
methods of construction used provide a high degree of protection at a TOLERABLE RISK for
the OPERATOR and the surrounding area, using RISK management where appropriate (see
annex AA).
Addition:
Add two new items:
h) biohazards;
i) hazardous chemical substances.
1.2.2 Aspects excluded from scope
Addition:
Add a new item and the following note:
g) 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:
Additions:
ISO 14971:2000, Medical devices – Application of risk management to medical devices
3 Terms and definitions
This clause of part 1 is applicable except as follows:
3.1 Equipment and states of equipment
Additional definitions:
3.101
HARM
physical injury or damage to the health of people, or damage to property or the environment
[ISO/IEC Guide 51:1999, definition 3.3]

61010-2-101  IEC:2002 – 13 –
3.102
RISK
combination of the probability of occurrence of HARM and the severity of that HARM
[ISO/IEC Guide 51:1999, definition 3.2]
3.103
TOLERABLE RISK
RISK which is accepted in a given context based on the current values of society
[ISO/IEC Guide 51:1999, definition 3.7]
NOTE 1 TOLERABLE RISK is the result of a balance between the ideal of absolute safety, the demands to be met by
a product, process or service, and factors such as benefit to the user, suitability of purpose, cost effectiveness,
RISK evaluation, conventions of the society concerned, and the state of the art.
NOTE 2 The term “acceptable risk” is used in ISO 14971 in the same sense as TOLERABLE RISK.
3.104
REASONABLY FORESEEABLE MISUSE
use of a product, process or service in a way not intended by the supplier, but which may
result from readily predictable human behaviour
[ISO/IEC Guide 51:1999, definition 3.14]
3.105
PERMANENTLY AFFIXED
removable only with a TOOL or by appreciable force and able to withstand the effects of
temperature, rubbing, common solvents, reagents and vapours encountered during normal
use
3.106
MARKING
inscription, in writing or as a graphical symbol, PERMANENTLY AFFIXED to a product
4 Tests
This clause of part 1 is applicable except as follows:
4.4.1 General
Replacement:
Replace item a) of the first paragraph by:
a) Equipment and circuit diagrams shall be examined to determine the fault con-
ditions which could arise in NORMAL USE and REASONABLY FORESEEABLE MISUSE,
and which could cause a HAZARD.
Deletion:
Delete the first dash.
61010-2-101  IEC:2002 – 15 –
Addition:
Additional subclause:
4.4.2.101 Incorrect voltage selection
Multivoltage equipment that can be set by the OPERATOR to different supply voltages shall be
set to each voltage in turn and then connected to all other RATED supply voltages in turn.
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, except for
symbol 101 (see table 1). Graphic symbols shall be explained in the documentation.
Table 1 – Symbols
Addition:
Add the following new symbols:
Number Symbol Publication Description
Background colour
– yellow;
101 ISO 7000 – 0659 Biohazard
symbol and outline
– black.
102 EN 980, subclause 4 Batch code
LOT
5.1.2 Identification
Replacement:
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;
b) model number, name, or other means of identifying the equipment;
c) where this is required by regulation, the name and address of the authorized represen-
tative of the manufacturer;
NOTE For example, in the EU this is the natural or legal person as established within the EC.

61010-2-101  IEC:2002 – 17 –
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:
i) a clear indication that the equipment is IVD medical equipment;
ii) if applicable, a clear indication that the equipment is self-test IVD medical
equipment;
iii) if a potential RISK is posed, the identification of detachable components by
manufacturer and part identification, and where appropriate the batch code, etc.
iv) any expiry date of
...