IEC 61010-2-081:2015

IEC 61010-2-081 ®
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 2-081: Particular requirements for automatic and semi-automatic laboratory
equipment for analysis and other purposes

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IEC 61010-2-081 ®
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 2-081: Particular requirements for automatic and semi-automatic laboratory

equipment for analysis and other purposes

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 19.080, 71.040.10 ISBN 978-2-8322-2241-6

– 2 – IEC 61010-2-081:2015 RLV © 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 . 7

6 Protection against electric shock . 9
7 Protection against mechanical HAZARDS . 9
8 Mechanical resistance to shock and impact Resistance to mechanical stresses . 9
9 Protection against the spread of fire . 9
10 Equipment temperature limits and resistance to heat . 10
11 Protection against hazards from fluids . 10
12 Protection against radiation, including laser sources, and against sonic and
ultrasonic pressure . 10
13 Protection against liberated gases and substances, explosion and implosion . 10
14 Components and subassemblies . 10
15 Protection by interlocks . 10
16 Test and measurement equipment HAZARDS resulting from application . 11
17 RISK assessment . 11
Annexes . 11
Annex H Index of defined terms .
Annex AA (normative) Risk management .
Annex BB (normative) Impact spring hammer (see 8.2) .

Bibliography . 11

Table 1 – Symbols . 7

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,
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 61010-2-081:2015 RLV © IEC 2015

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 second edition cancels and replaces the first edition published in 2001 and its

Amendment 1 (2003). It constitutes a technical revision and includes the following significant

changes from the first edition, as well as numerous other changes:

• excluded IEC 61010-2-101 (IVD Equipment) from scope. This separates IEC 61010-2-081

and IEC 61010-2-101 equipment;

• added biological risks symbol to Table 1 in Clause 5;
• added requirement for statement on hazardous substances and gases in Instructions for
Use to Clause 5;
• Added marking requirement for flow direction 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 requirement for interlock systems containing electric/electronic or programmable
components to Clause 15.
The text of this standard is based on the following documents:
FDIS Report on voting
66/544/FDIS 66/559/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 2-081 is intended to be used in conjunction with IEC 61010-1. It was established on
the basis of the third edition (2010).

This Part 2-081 supplements or modifies the corresponding clauses in IEC 61010-1 so as to
convert that publication into the IEC standard: Safety 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, 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, 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 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.
IMPORTANT – The “colour inside” logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct understanding
of its contents. Users should therefore print this publication using a colour printer.

– 6 – IEC 61010-2-081:2015 RLV © IEC 2015

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 by the following:
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 standard.
Examples of equipment within the scope of this standard 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 standards of IEC 61010
as well as within the scope of this standard, it will also need to meet the requirements of considerations have to be
given to those other part 2 standards.
1.1.2 Equipment excluded from scope
Addition:
Add the following item:
aa) IEC 61010-2-101 (IVD Equipment)

1.2 Object
1.2.1 Aspects included in scope

Replacement:
Replace the first sentence by the following:

The purpose of this standard is to ensure that the design and 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 specified (see 7.2.101 and annex AA).

Addition:
Add the following items:
aa) biohazards;
bb) hazardous chemical substances.
1.2.2 Aspects excluded from scope
Addition:
Add the following item and note:
g 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 except as follows.
Addition:
IEC 60068-2-75:1997, Environmental testing – Part 2-75: Test – Test Eh: Hammer tests
3 Terms and definitions
This clause of Part 1 is applicable except as follows.

3.1 Equipment and states of equipment
Additions:
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]
3.102
RISK
combination of the probability of occurrence of HARM and the severity of that HARM

– 8 – IEC 61010-2-081:2015 RLV © IEC 2015

[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 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.

4 Tests
This clause of Part 1 is applicable except as follows.
4.4.2 Application of fault conditions
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 international
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
Additions:
Add the following symbol to Table 1:
Number Symbol Publication Description
Background colour
– yellow optional;
Symbol colour Biohazard
101 ISO 7000-0659 (2004-01)
– optional; Biological risks
Outline / outline colour
– black optional;
5.1.5 TERMINALS, connections and operating devices

Additions:
Add the following new note 3:
NOTE 3 All connectors, controls and indicators necessary for use by the OPERATOR should be marked.

Add the following subclause:
5.1.5.101 Gas and liquid connections

If necessary for safety, the equipment shall be clearly marked near to 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.
5.2 Warning markings
Replacement:
Replace the fifth first paragraph by the following five paragraphs:
Equipment that can be potentially infectious due to the samples or reagents used shall be
prominently marked with symbol 101 of Table 1.
Equipment that can be hazardous due to the use of chemical substances shall be marked with
the appropriate symbol, or (if none is available) symbol 14 of Table 1.
Protective covers shall be marked to warn the OPERATOR not to open or remove them except
as permitted by 7.2.101 or 7.2.102.
Any part of the equipment that contains biohazardous waste material which can be removed
from the equipment during NORMAL USE shall be marked with symbol 101 of Table 1.

Warning markings specified in 5.1.5.1, 5.1.5.2 c), 5.1.5.101, 6.1.2 b), 6.5.1.2 g), 6.6.2, 7.2 c),
7.2.101 f), 7.2.102 c), 7.3.2 b) 3), 7.4, 10.1, 13.2.2 and 13.101 shall meet the following
requirements.
5.3 Durability of markings
Replacement:
Replace the first paragraph by the following paragraph:
Markings required by 5.1.2 to 5.2 shall be permanently affixed 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 temperature and rubbing, and of solvent and reagents likely to be
NORMAL USE, including cleaning and decontaminating agents specified by the
encountered in
manufacturer.
Addition:
– 10 – IEC 61010-2-081:2015 RLV © IEC 2015

Add after the first second paragraph the following paragraph:

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

particular marking, that marking is also rubbed for 30 s with each the most frequently used

and/or aggressive solvent or reagent to which the equipment is likely to be exposed in NORMAL

USE. (or with A 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 in the second paragraph.
Addition:
Add a new third paragraph as follows:
Information shall be given about any RISKS not reduced to a TOLERABLE RISK level by the
protective measures specified in this standard. If there is a need for training or for the use of
additional protective devices or personal protective equipment to reduce RISKS to a TOLERABLE
RISK level, these shall be specified.
5.4.3 Equipment installation
Replacement:
Replace the title and text by the following:

5.4.3 Equipment transportation, installation and assembly instructions
Documentation for the RESPONSIBLE BODY shall include the following as applicable:
a) instructions for transportation after delivery to the RESPONSIBLE BODY;
b) floor loading requirements;
c) individual weights of principal heavy sub-assemblies;
d) location and mounting instructions, including the space required for ventilation, and for
safe and efficient OPERATOR maintenance;
e) assembly instructions;
f) instructions for protective earthing;
g) the sound data required by 12.5.1;
h) instructions relating to the handling, containment and exhaust of hazardous substances,
including any requirements for preventing back-syphonage;
i) any drainage systems required where a HAZARD could occur from the discharge of
biological and chemical substances and hot fluids;
j) details of protective measures relating to hazardous radiation (see clause 12);
k) instructions for connections to the supply;
l) for PERMANENTLY CONNECTED EQUIPMENT only:
1) mains supply requirements and details of connections, including the RATED
temperature of the cable required at maximum RATED ambient temperature;
2) requirements for any external switches, circuit-breakers (see 6.11.2.1) or overcurrent
protection devices (see 9.5). A recommendation that a switch or circuit breaker be
near the equipment shall also be included if this is necessary for safety;

m) requirements for special services (for example air, cooling liquid) including pressure limits.

Conformity is checked by inspection of the documentation.

5.4.4 Equipment operation
Replacement:
Instructions for use shall include if applicable:

a) details of operating controls and their use in all operating modes with any sequence of

operation;
NOTE 1 IEC 60073 gives guidance on colours and symbols of operating controls.
b) an instruction not to position the equipment so that it is difficult to operate the
disconnecting device (see 6.11);
c) instructions for interconnections to accessories and other equipment, including details of
suitable accessories, detachable parts and any special materials;
d) limits for intermittent operation;
e) an explanation of symbols used on the equipment and, where HAZARDS are involved, the
reason for using a symbol in each particular case;
f) instructions for any actions to be taken by an OPERATOR in case of a malfunction;
g) instructions and recommendations for cleaning and decontamination, with materials
recommended (see 11.2);
h) instructions for the disposal of waste;
i) if NORMAL USE involves the handling of hazardous substances, instructions on correct use
and any need for training or personal protection measures;
j) if there could be contact with the skin when handling potentially infectious substances
(such as human samples or reagents), the need to use protective gloves;
k) if the equipment could emit hazardous aerosol vapours in NORMAL USE, instructions for
protection of the mouth, nose or eyes;
l) if potentially hazardous visible or invisible radiation could be emitted, instructions and
requirements for protective devices, such as protective glasses;
m) instructions relating to access to moving parts (see 7.2.101 and 7.2.102).
There shall be a statement in the instructions that, if the equipment is used in a manner not
specified by the manufacturer, the protection provided by the equipment may be impaired.
NOTE 2 Manufacturers should be aware of 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.
NOTE 3 Cleaning and decontamination may be necessary as a safeguard when equipment and its accessories
are maintained, repaired, or transferred. Manufacturers should provide a format for RESPONSIBLE BODIES to certify
to those maintaining, repairing or transferring equipment that such a treatment has been carried out.
Conformity is checked by inspection of the documentation.
Replace the text in item h) by the following item h) and note:
h) a statement listing any potentially poisonous or injurious gases or substances that can be
liberated from the equipment, and possible quantities;
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:
– 12 – IEC 61010-2-081:2015 RLV © IEC 2015

Add the following subclauses:
5.4.101 Removal of equipment from use for repair or disposal

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

involved in removal from use, transportation or disposal. These instructions shall include

requirements for minimizing biohazards, if any, 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.
7 Protection against mechanical HAZARDS
This clause of Part 1 is applicable except as follows:
7.2 Moving parts
Deletion
Delete paragraphs two and three.
Addition:
Additional subclauses:
7.2.101 Accessibility during NORMAL USE
As an exception, if moving parts are unavoidably exposed in NORMAL USE, RISK management
(see annex AA) shall be carried out to establish whether the moving parts could cause injury
to the OPERATOR. Any RISKS shall be minimized as far as practible by protective measures, in
the following order of priority:
a) protective devices (interlock systems or other means, removable only with a TOOL);
b) protective covers;
c) mechanical BARRIERS;
d) sufficient distance between safe areas and moving parts;
e) warning signals (audible or visible);
f) warning markings (see 5.2).
Measures b) to d) shall be combined with warnings regarding hazardous areas (see 5.4.1).
If moving parts are unavoidably exposed during NORMAL USE, the instructions shall specify that
procedures which could result in injury are carried out only by OPERATORS who have been
warned of the potential HAZARDS and have received adequate training in carrying out the
procedures in the safest possible manner.
Conformity is checked by inspection and as specified in annex AA.

7.2.102 Accessibility outside NORMAL USE

If an OPERATOR carrying out routine maintenance outside NORMAL USE has, for unavoidable

technical reasons, to perform a procedure, such as adjustment which requires access to

hazardous moving parts, access is permitted provided that all of the following precautions

have been taken:
a) access to moving parts protected by devices specified in 7.2.101 a) is not possible without

the use of a TOOL;
b) the instructions for the RESPONSIBLE BODY include a statement that OPERATORS must be

trained before being allowed to perform the hazardous procedure;

c) there are warning markings (see 5.2) on any covers or parts which have to be removed to
obtain access and the warning prohibits access by untrained OPERATORS. As an alternative,
symbol 14 of Table 1 shall be placed on the covers or parts and the warnings included in the
documentation.
Conformity is checked by inspection and as specified in annex AA.
7.3.2 Exceptions
Replacement:
Replace the text in item b) 3) by the following:
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 item:
b) 4) There are OPERATOR maintenance instructions that specify safe maintenance
procedures.
8 Mechanical Resistance to shock and impact Resistance to mechanical
stresses
This clause of Part 1 is applicable except as follows:
8.1.2 Dynamic test
Replacement:
• Impact hammer test
Bases, covers, etc., intended to be removed and replaced by the OPERATOR have their fixing
screws tightened with the torque applied in NORMAL USE. The equipment is then held firmly
against a rigid support and tested with the impact spring hammer specified in Annex BB. The
hammer nose is pressed perpendicularly against the surface of all external parts which are
accessible in NORMAL USE and which would be likely to cause a hazard if broken.
Three blows with an energy of 0,5 J are applied to each part.

– 14 – IEC 61010-2-081:2015 RLV © IEC 2015

NOTE A revised impact test is under consideration.

8.2.1 Equipment other than HAND-HELD EQUIPMENT and direct plug-in equipment

8.1 General
Replacement:
Replace the text of c item 3) by the following:

c3) no test is required 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
This clause of Part 1 is applicable except as follows:
11.3 Spillage
Replacement:
If in NORMAL USE, liquid is likely to be spilled into the equipment, the equipment shall be
designed so that no HAZARD will occur, as a result of the wetting of insulation or of internal
uninsulated parts which are HAZARDOUS LIVE, or as a result of the contact of potentially
aggressive substances (such as corrosive, toxic or flammable liquids) with parts of the
equipment.
Conformity is checked by inspection. In case of doubt, 0,2 l of water is poured steadily from a
height of 0,1 m over a period of 15 s onto each point in turn at the area where the OPERATOR
has to pour in or handle liquids, and where the liquid might gain access to electrical parts.

In areas where an automatic dosing process is performed, the above test is also carried out
using a volume of water equal to 5 times the maximum amount of liquid which is likely to be
spilled during NORMAL USE by the equipment itself.
Immediately after this treatment, the equipment shall pass the voltage tests of 6.8 (without
humidity preconditioning) and ACCESSIBLE parts shall not exceed the limits of 6.3.1.
Where appropriate, conformity is also checked by an examination of the compatibility of
potentially aggressive substances with contacted parts of the equipment.
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:

Modification:
Modify the title of the clause as follows:

13 Protection against liberated gases and substances, explosion and implosion

13.1 Poisonous and injurious gases
Modification:
Modify the title as follows:
13.1 Poisonous and injurious gases and substances
Replacement:
Replace the first paragraph by the following two new paragraphs:
Equipment shall not liberate dangerous amounts of poisonous or injurious gases or
substances in NORMAL CONDITION or in SINGLE FAULT CONDITION.
If potentially hazardous substances are liberated, the OPERATOR shall not be wetted nor be
able to inhale quantities likely to be hazardous. The areas of the equipment containing such
substances shall be equipped with protective covers or similar means of protection.
Addition:
Add the following 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 near the sampling area and visible in NORMAL USE.

Biohazard symbols shall be near biohazardous areas accessed during OPERATOR maintenance
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.

– 16 – IEC 61010-2-081:2015 RLV © IEC 2015

15 Protection by interlocks
This clause of Part 1 is applicable except as follows.

15.1 General
Addition:
Add the following 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 e.g. IEC 62061 (SIL) or ISO 13849 (PL) or other solutions providing equivalent
functional safety.
16 Test and measurement equipment 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 except as follows.
Additions:
Annex H
Index of defined terms
Additional defined terms:
HARM . 3.101
RISK . 3.102
TOLERABLE RISK . 3.103

Add the following two new annexes AA and BB as follows:

Annex AA
(normative)
Risk management
To meet the requirements of 7.2.101, a satisfactory level of safety shall be achieved by RISK

reduction to achieve at least a TOLERABLE RISK. RISK management shall be carried out, and
documented, to achieve at least a TOLERABLE RISK by an iterative process covering the
following.
a) RISK analysis
RISK analysis is the process to identify hazards and to estimate the RISKS based on the
use of available information.
b) RISK evaluation
Each RISK analysis requires a plan to work out the estimated severity and probability of a
RISK level, and to judge the acceptability of the resulting RISK level. Acceptability of RISK
levels is judged as follows (see Figure AA.1):
1) Broadly acceptable region
In some cases, the RISK is so low, that it is negligible in comparison with other RISKS
and in view of the benefit of using the equipment. In such cases the RISK is acceptable
and RISK control need not be actively pursued. This level fulfils the requirement for
TOLERABLE RISK.
2) RISK as low as reasonably practicable region (ALARP)
This level does not automatically fulfil the requirement for TOLERABLE RISK. ALARP as a
result in a RISK analysis always needs a justification of why the RISK cannot be reduced
further in a practicable way.
3) Intolerable region
This level contains RISKS that are not TOLERABLE RISKS.
c) RISK reduction
If the initial RISK is not acceptable, counter measures shall be identified and put into force.
The process of RISK analysis and RISK evaluation shall then be repeated, including
checking that counter measures have not introduced new RISKS.

NOTE 1 For IVD medical equipment within the scope of IEC 61010-2-101, the RISK management process
specified in that standard applies.For other equipment, guidance on RISK management is given in the following
standards: ISO 14971 and ISO 14121.
NOTE 2 Where ISO 14121 requires conformity with a recommendation of ISO/TR 12100-2, that recommendation
is replaced by the relevant requirement of IEC 61010.

– 18 – IEC 61010-2-081:2015 RLV © IEC 2015

Intolerable
region
ALARP
region
Broadly acceptable
region
Increasing SEVERITY of HARM
IEC  2428/01
Figure AA.1 – RISK acceptability

Increasing probability of occurrence

Annex BB
(normative)
Impact spring hammer (see 8.2)

IEC 60068-2-75 describes the construction, the application and the calibration of the spring

hammer Ehb. The following brief description is not intended to give full details of how to make

or calibrate the apparatus.
The test apparatus (see figure below) consists of three main parts: the body, the striking
element and the spring-loaded release cone.
The body comprises the housing, the striking element guide, the release mechanism and all
parts rigidly fixed thereto.
The striking element comprises the hammer head, the hammer shaft and the cocking knob.
The hammer head has a hemispherical face of polyamide having a Rockwell hardness of
HR 100, with a radius of 10 mm; it is so fixed to the hammer shaft that the distance from its tip
to the plane of the front of the cone when the striking element is on the point of release is
20 mm.
The cone has a mass of 60 g and the cone spring is such that it exerts a force of 20 N when
the release jaws are on the point of releasing the striking element.
The apparatus is cocked by pulling the cocking knob until the release jaws engage in the
hammer shaft.
For an impact energy of 0,5 J + 0,05 J, the hammer spring is adjusted so that the product of
the compression, in millimetres, and the force exerted, in newtons, equals 1 000, the com-
pression being approximately 20 mm.
For other energy levels, adjust as described in IEC 60068-2-75 or according to the
instructions supplied with the apparatus.

Figure BB.1 – Impact spring hammer

– 20 – IEC 61010-2-081:2015 RLV © IEC 2015

Bibliography
Addition:
Add the following reference:
IEC 60073:1996, Basic and safety principles for man-machine interface, marking and

identification – Coding principles for induction devices and actuators

ISO/IEC Guide 51:1999, Safety aspects – Guidelines for their inclusions in standards

ISO 7000:1989, Graphical symbols for use on equipment – Index and synopsis
ISO/TR 12100-2:1992, Safety of machines – Basic concepts, general principles for design –
Part 2: Technical principles and specifications
ISO 14121:1999, Safety of machinery – Principles of risk assessment
ISO 14971:2000, Medical devices – Application of risk management to medical devices
World Health Organization, Laboratory biosafety manual, 1984

___________
IEC 61010-2-081 ®
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 2-081: Particular requirements for automatic and semi-automatic laboratory
equipment for analysis and other purposes

Règles 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 autres usages

– 2 – IEC 61010-2-081:2015 © 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 . 7

6 Protection against electric shock . 9

7 Protection against mechanical HAZARDS .
...