Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-081: Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes

IEC 61010-2-081:2019 is available as IEC 61010-2-081:2019 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC 61010-2-081:2019 applies to automatic and semi-automatic laboratory equipment for analysis and other purposes. Automatic and semi-automatic laboratory equipment consists of instruments or systems for measuring or modifying one or more characteristics or parameters of samples, performing the complete process or parts of the process without manual intervention. Equipment forming part of such a system is within the scope of this document. This third edition cancels and replaces the second edition published in 2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
- adaptation of changes introduced by Amendment 1 of IEC 61010-1:2010;
- added tolerance for stability of AC voltage test equipment to Clause 6.
It has the status of a group safety publication in accordance with IEC Guide 104.

Exigences de sécurité pour appareils électriques de mesurage, de régulation et de laboratoire - Partie 2-081: Exigences particulières pour les appareils de laboratoire, automatiques et semi-automatiques, destinés à l'analyse et à d'autres usages

IEC 61010-2-081:2019 est disponible sous forme de IEC 61010-2-081:2019 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.
L'IEC 61010-2-081:2019 s'applique aux appareils de laboratoire, automatiques et semi-automatiques, destinés à l'analyse et à d'autres usages. Les appareils de laboratoire automatiques et semi-automatiques comprennent les instruments ou systèmes utilisés pour mesurer ou modifier un ou plusieurs paramètres ou caractéristiques d'échantillons, réalisant tout ou partie du processus sans intervention manuelle. Les appareils faisant partie d'un tel système sont couverts par le domaine d'application du présent document. Cette troisième édition annule et remplace la deuxième édition parue en 2015. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente:
- adaptation des modifications introduites par l'Amendement 1 de l'IEC 61010-1:2010;
- ajout de la tolérance de stabilité pour les appareils d'essai de tension en courant alternatif à l'Article 6.
Elle a le statut d'une publication groupée de sécurité conformément au Guide IEC 104.

General Information

Status
Published
Publication Date
11-Feb-2019
Current Stage
PPUB - Publication issued
Completion Date
12-Feb-2019
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IEC 61010-2-081
Edition 3.0 2019-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
GROUP SAFETY PUBLICATION
PUBLICATION GROUPÉE DE SÉCURITÉ
Safety requirements for electrical equipment for
measurement, control, and laboratory use –
Part 2-081: Particular requirements for automatic and semi-automatic
laboratory equipment for analysis and other purposes
Exigences de sécurité pour appareils électriques de mesurage, de régulation et
de laboratoire –
Partie 2-081: Exigences particulières pour les appareils de laboratoire,
automatiques et semi-automatiques, destinés à l'analyse et à d'autres usages
IEC 61010-2-081:2019-02(en-fr)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
IEC 61010-2-081
Edition 3.0 2019-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
GROUP SAFETY PUBLICATION
PUBLICATION GROUPÉE DE SÉCURITÉ
Safety requirements for electrical equipment for
measurement, control, and laboratory use –
Part 2-081: Particular requirements for automatic and semi-automatic
laboratory equipment for analysis and other purposes
Exigences de sécurité pour appareils électriques de mesurage, de régulation et
de laboratoire –
Partie 2-081: Exigences particulières pour les appareils de laboratoire,
automatiques et semi-automatiques, destinés à l'analyse et à d'autres usages
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 19.080; 71.040.10 ISBN 978-2-8322-6501-7

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: 3 ----------------------
– 2 – IEC 61010-2-081:2019 © IEC 2019
CONTENTS

FOREWORD ........................................................................................................................... 3

1 Scope and object ............................................................................................................. 5

2 Normative references ...................................................................................................... 6

3 Terms and definitions ...................................................................................................... 6

4 Tests ............................................................................................................................... 6

5 Marking and documentation ............................................................................................. 6

6 Protection against electric shock ..................................................................................... 8

7 Protection against mechanical HAZARDS ........................................................................... 8

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

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

10 Equipment temperature limits and resistance to heat ....................................................... 9

11 Protection against HAZARDS from fluids and solid foreign objects ..................................... 9

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

ultrasonic pressure .......................................................................................................... 9

13 Protection against liberated gases and substances, explosion and implosion .................. 9

14 Components and subassemblies ..................................................................................... 9

15 Protection by interlocks ................................................................................................... 9

16 HAZARDS resulting from application ................................................................................ 10

17 RISK assessment ........................................................................................................... 10

Annexes ............................................................................................................................... 10

Bibliography .......................................................................................................................... 11

Table 1 – Symbols .................................................................................................................. 6

---------------------- Page: 4 ----------------------
IEC 61010-2-081:2019 © IEC 2019 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR
MEASUREMENT, CONTROL, AND LABORATORY USE –
Part 2-081: Particular requirements for automatic and semi-automatic
laboratory equipment for analysis and other purposes
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,

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Publication(s)"). Their preparation is entrusted to technical committees; any IEC National Committee interested

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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

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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 61010-2-081 has been prepared by IEC technical committee 66:

Safety of measuring, control and laboratory equipment.

It has the status of a group safety publication in accordance with IEC Guide 104.

This third edition cancels and replaces the second edition published in 2015. This edition

constitutes a technical revision.

This edition includes the following significant technical changes with respect to the previous

edition:
• adaptation of changes introduced by Amendment 1 of IEC 61010-1:2010;
• added tolerance for stability of AC voltage test equipment to Clause 6.
---------------------- Page: 5 ----------------------
– 4 – IEC 61010-2-081:2019 © IEC 2019
The text of this International Standard is based on the following documents:
CDV Report on voting
66/652/CDV 66/671A/RVC

Full information on the voting for the approval of this International Standard can be found in

the report on voting indicated in the above table.

This document has been drafted in accordance with the ISO/IEC Directives, Part 2.

A list of all parts of the IEC 61010 series, published under the general title Safety

requirements for electrical equipment for measurement, control, and laboratory use, can be

found on the IEC website.

This Part 2-081 is to be used in conjunction with IEC 61010-1. It was established on the basis

of the third edition (2010) and its Amendment 1 (2016), hereinafter referred to as Part 1.

This Part 2-081 supplements or modifies the corresponding clauses in IEC 61010-1 so as to

convert that publication into the IEC standard: Particular requirements for automatic and

semi-automatic laboratory equipment for analysis and other purposes.

Where a particular subclause of Part 1 is not mentioned in this Part 2-081, that subclause

applies as far as is reasonable. Where this Part 2-081 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, figures, tables and notes which are additional to those in Part 1 are numbered

starting from 101. Additional annexes are lettered starting from AA and additional list

items are lettered from aa).

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

stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to

the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
---------------------- Page: 6 ----------------------
IEC 61010-2-081:2019 © IEC 2019 – 5 –
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR
MEASUREMENT, CONTROL, AND LABORATORY USE –
Part 2-081: Particular requirements for automatic and semi-automatic
laboratory equipment for analysis and other purposes
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, except the first paragraph, by the following new text:

This part of IEC 61010 applies to automatic and semi-automatic laboratory equipment for

analysis and other purposes.

Automatic and semi-automatic laboratory equipment consists of instruments or systems for

measuring or modifying one or more characteristics or parameters of samples, performing the

complete process or parts of the process without manual intervention. Equipment forming part

of such a system is within the scope of this document.
Examples of equipment within the scope of this document include:
• analytical equipment;
• automatic sampler (pipettor, aliquoter);
• equipment for sample replication and amplification.

NOTE 1 In the case of analytical equipment, the complete process usually includes the following steps:

• taking a specific quantity of the sample;
• preparing the sample by chemical, thermal, mechanical or other means;
• measurement;
• display, transmission or printing of the results of measurement.

NOTE 2 If all or part of the equipment falls within the scope of one or more other Part 2 documents of IEC 61010

as well as within the scope of this document, consideration is given to those other Part 2 documents.

1.1.2 Equipment excluded from scope
Addition:
Add the following new item:
aa) IEC 61010-2-101 (in vitro diagnostic (IVD) equipment).
---------------------- Page: 7 ----------------------
– 6 – IEC 61010-2-081:2019 © IEC 2019
1.2 Object
1.2.1 Aspects included in scope
Addition:
Add the following new items:
aa) biohazards;
bb) hazardous chemical substances.
1.2.2 Aspects excluded from scope
Addition:
Add the following new item and note:
aa) handling or manipulation of material outside the equipment.

NOTE Requirements covering these subjects are the responsibility of committees preparing the relevant

standards.
2 Normative references
This clause of Part 1 is applicable.
3 Terms and definitions
This clause of Part 1 is applicable.
4 Tests
This clause of Part 1 is applicable.
5 Marking and documentation
This clause of Part 1 is applicable except as follows:
Table 1 – Symbols
Addition:
Add the following new symbol to Table 1:
Number Symbol Reference Description
Background colour
– optional
Symbol colour
101 ISO 7000-0659 (2004-01) Biological risks
– optional
Outline / outline colour
– optional
---------------------- Page: 8 ----------------------
IEC 61010-2-081:2019 © IEC 2019 – 7 –
Add the following new subclause:
5.1.5.101 Gas and liquid connections

If necessary for safety, the equipment shall be clearly marked near the connector on the

equipment with:

a) a means of identifying the gas or liquid to be used. Where no internationally recognized

symbol (including chemical formulae) exists, the equipment shall be marked with
symbol 14 of Table 1;

b) the maximum permitted pressure, or alternatively symbol 14 of Table 1 (see 5.4.3);

c) flow direction of the gas and liquid, if applicable.
Conformity is checked by inspection.
5.3 Durability of markings
Replacement:
Replace the first paragraph with the following new text:

Markings required by 5.1.2 to 5.2 shall be removable only with a TOOL or by appreciable force

and shall remain clear and legible under conditions of NORMAL USE, and resist the effects of

NORMAL USE,
temperature and rubbing, and of solvent and reagents likely to be encountered in
including cleaning and decontaminating agents specified by the manufacturer.
Addition:
Add the following new paragraph after the second paragraph:

If a solvent or reagent specified for use with the equipment could affect the durability of a

particular marking, that marking is also rubbed for 30 s with the most frequently used and/or

NORMAL USE. A
aggressive solvent or reagent to which the equipment is likely to be exposed in

representative sample of groups of solvents or reagents likely to have a similar effect can

optionally be used.
5.4.1 General
Deletion:
Delete Note 2.
5.4.4 Equipment operation
Addition:
Add the following note to item h):

NOTE Manufacturers can find valuable details in the internationally recognized Laboratory Biosafety Manual,

published by the World Health Organization. This gives information on decontaminants, their use, dilutions and

potential applications. There are also national guidelines that cover these areas.

Addition:
Add the following new subclause:
---------------------- Page: 9 ----------------------
– 8 – IEC 61010-2-081:2019 © IEC 2019
5.4.101 Removal of equipment from use for repair or disposal

Instructions shall be provided to the RESPONSIBLE BODY for eliminating or reducing HAZARDS

involved in removal from use, transportation or disposal, or appropriate contact information

shall be provided in the instructions.
NOTE Regional or international requirements can apply.
Conformity is checked by inspection of the documentation.
6 Protection against electric shock
This clause of Part 1 is applicable except as follows:
6.8.3.1 The AC voltage test
Replacement:
Replace the first sentence by the following new sentence:

The voltage tester shall be capable of maintaining the test voltage throughout the test within

±5 % of the specified value.
7 Protection against mechanical HAZARDS
This clause of Part 1 is applicable except as follows:
7.3.2 Exceptions
Replacement:
Replace the text in item b) 3) by the following new text:

there are warning markings prohibiting access by untrained OPERATORS. Markings shall be

placed within the area requiring maintenance where they can alert the OPERATOR to the

HAZARD. As an alternative, symbol 14 of Table 1 can be used, with the warnings included in

the documentation.
Addition:
Add the following new item:
b) 4) there are OPERATOR maintenance instructions that specify safe maintenance
procedures.
8 Resistance to mechanical stresses
This clause of Part 1 is applicable except as follows:
8.1 General
Replacement:
Replace the text of item 3) by the following new text:
---------------------- Page: 10 ----------------------
IEC 61010-2-081:2019 © IEC 2019 – 9 –

3) except for FIXED EQUIPMENT, for equipment with a mass over 100 kg, or for equipment

whose size and weight make unintentional movement unlikely and which is not moved in

NORMAL USE, the appropriate test of 8.3. The equipment is not operated during the tests.

9 Protection against the spread of fire
This clause of Part 1 is applicable.
10 Equipment temperature limits and resistance to heat
This clause of Part 1 is applicable.
11 Protection against HAZARDS from fluids and solid foreign objects
This clause of Part 1 is applicable.
12 Protection against radiation, including laser sources, and against sonic and
ultrasonic pressure
This clause of Part 1 is applicable.
13 Protection against liberated gases and substances, explosion and implosion
This clause of Part 1 is applicable except as follows:
Addition:
Add the following new subclause:
13.101 Biohazardous substances

Equipment that can be potentially biohazardous due to the use of biohazardous substances

shall be prominently marked with symbol 101 of Table 1, or the appropriate international

symbol, or (if none is available) symbol 14 of Table 1.

At minimum, a biohazard symbol shall be located near the sampling area and be visible in

NORMAL USE.

Biohazard symbols shall be located near biohazardous areas accessed during OPERATOR

maintenance and visible only during this maintenance.

Any part of the equipment that contains biohazardous waste material which can be removed

from the equipment during NORMAL USE or a biohazardous drain connection shall be marked

with an appropriate biohazard symbol.
14 Components and subassemblies
This clause of Part 1 is applicable.
15 Protection by interlocks
This clause of Part 1 is applicable except as follows.
---------------------- Page: 11 ----------------------
– 10 – IEC 61010-2-081:2019 © IEC 2019
15.1 General
Addition:
Add the following new text after the first sentence:

As an alternative method, for interlock systems containing electric/electronic or programmable

components (E/E/P components) the reliability and design requirements can be determined by

applying, for example IEC 62061 (SIL) or ISO 13849 (PL) (all parts) or other solutions

providing equivalent functional safety.
16 HAZARDS resulting from application
This clause of Part 1 is applicable.
17 RISK assessment
This clause of Part 1 is applicable.
Annexes
The annexes of Part 1 are applicable.
---------------------- Page: 12 ----------------------
IEC 61010-2-081:2019 © IEC 2019 – 11 –
Bibliography
Addition:
Add the following new references:

IEC 61010-2-101, Safety requirements for electrical equipment for measurement, control, and

laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical

equipment

IEC 62061, Safety of machinery – Functional safety of safety-related electrical, electronic and

programmable electronic control systems

ISO 13849 (all parts), Safety of machinery – Safety-related parts of control systems

World Health Organization, Laboratory biosafety manual
_____________
---------------------- Page: 13 ----------------------
– 12 – IEC 61010-2-081:2019 © IEC 2019
SOMMAIRE

AVANT-PROPOS .................................................................................................................. 13

1 Domaine d'application et objet ....................................................................................... 15

2 Références normatives .................................................................................................. 16

3 Termes et définitions ..................................................................................................... 16

4 Essais ........................................................................................................................... 16

5 Marquage et documentation .......................................................................................... 16

6 Protection contre les chocs électriques .......................................................................... 18

7 Protection contre les DANGERS mécaniques ................................................................... 18

8 Résistance aux contraintes mécaniques ........................................................................ 18

9 Protection contre la propagation du feu ......................................................................... 19

10 Limites de température de l'appareil et résistance à la chaleur ...................................... 19

11 Protection contre les DANGERS des fluides et des corps solides étrangers ...................... 19

12 Protection contre les radiations, y compris les sources laser, et contre la pression

acoustique et ultrasonique ............................................................................................. 19

13 Protection contre les émissions de gaz et substances, les explosions et les

implosions ..................................................................................................................... 19

14 Composants et sous-ensembles .................................................................................... 19

15 Protection par systèmes de verrouillage ........................................................................ 20

16 DANGERS résultant de l'application ................................................................................. 20

17 Appréciation du RISQUE .................................................................................................. 20

Annexes ............................................................................................................................... 20

Bibliographie ......................................................................................................................... 21

Tableau 1 – Symboles .......................................................................................................... 16

---------------------- Page: 14 ----------------------
IEC 61010-2-081:2019 © IEC 2019 – 13 –
COMMISSION ÉLECTROTECHNIQUE INTERNATIONALE
____________
EXIGENCES DE SÉCURITÉ POUR APPAREILS ÉLECTRIQUES DE
MESURAGE, DE RÉGULATION ET DE LABORATOIRE –
Partie 2-081: Exigences particulières pour les appareils de laboratoire,
automatiques et semi-automatiques, destinés à l'analyse et à d'autres
usages
AVANT-PROPOS

1) La Commission Electrotechnique Internationale (IEC) est une organisation mondiale de normalisation

composée de l'ensemble des comités électrotechniques nationaux (Comités nationaux de l'IEC). L'IEC a pour

objet de favoriser la coopération internationale pour toutes les questions de normalisation dans les domaines

de l'électricité et de l'électronique. A cet effet, l'IEC – entre autres activités – publie des Normes

internationales, des Spécifications techniques, des Rapports techniques, des Spécifications accessibles au

public (PAS) et des Guides (ci-après dénommés "Publication(s) de l'IEC"). Leur élaboration est confiée à des

comités d'études, aux travaux desquels tout Comité national intéressé par le sujet traité peut participer. Les

organisations internationales, gouvernementales et non gouvernementales, en liaison avec l'IEC, participent

également aux travaux. L'IEC collabore étroitement avec l'Organisation Internationale de N

...

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