IEC 61010-2-101:2015

IEC 61010-2-101 ®
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 2-101: Particular requirements for in vitro diagnostic (IVD) medical
equipment
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IEC 61010-2-101 ®
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 2-101: Particular requirements for in vitro diagnostic (IVD) medical

equipment
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.55, 19.080 ISBN 978-2-8322-2242-3

– 2 – IEC 61010-2-101:2015 RLV © IEC 2015

CONTENTS
FOREWORD . 3

1 Scope and object . 6

2 Normative references . 7

3 Terms and definitions . 7

4 Tests . 9

5 Marking and documentation . 9

6 Protection against electric shock . 14
7 Protection against mechanical HAZARDS . 14
8 Mechanical resistance to shock and impact Resistance to mechanical stresses . 16
9 Protection against the spread of fire . 17
10 Equipment temperature limits and resistance to heat . 17
11 Protection against HAZARDS from fluids . 17
12 Protection against radiation, including laser sources, and against sonic and
ultrasonic pressure . 17
13 Protection against liberated gases and substances, explosion and implosion . 17
14 Components and subassemblies . 18
15 Protection by interlocks . 18
16 Measuring circuits HAZARDS resulting from application . 19
17 RISK assessment . 19

Annexes . 19
Annex H L (informative) Index of defined terms . 19
Annex AA (normative) Risk management .
Annex BB (normative) Instructions for use for self-test IVD medical equipment .
Bibliography . 26

Table 1 – Symbols . 9

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 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
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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 61010-2-101:2015 RLV © IEC 2015

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 publication, as specified in IEC Guide 104.

This standard has been prepared in close collaboration with Working Group CENELEC
BTTF 88.1.
This second edition cancels and replaces the first edition published in 2002. It constitutes a
technical revision and includes the following significant changes from the first edition, as well
as numerous other changes:
• excluded IEC 61010-2-081 (general laboratory equipment) from the 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 and 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, burns from surfaces,
and loading and unloading of sample and reagents 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 normative reference ISO 18113-5 for instructions for use of self-test IVD medical
equipment in Clause 5;
• added requirement for OPERATOR maintenance instructions to Clause 7;
• added requirements for sample zones and loading zones 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;
• added informative reference to Usability standard IEC 62366 to Clause 16;
• replaced Clause 17 with requirements of ISO 14971 for RISK assessment.
• Annex BB Instructions for use for self-testing IVD Medical Equipment deleted and a

reference given to ISO 18113-5 in Clause 5.
The text of this standard is based on the following documents:
FDIS Report on voting
66/545/FDIS 66/560/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 2-101 is intended to be used in conjunction with IEC 61010-1. It was established on

the basis of the third edition (2010).

This Part 2-101 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.
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 61010-2-101:2015 RLV © IEC 2015

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:
Replace the text by the following:
This part of IEC 61010 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 considerations have to be
given to those other part 2 standards.
1.1.2 Equipment excluded from scope

Addition:
Add the following item:
aa) Products for general laboratory use are not IVD medical devices unless such products,
in view of their characteristics, Equipment 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

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 items:
h aa)  biohazards;
i bb)  hazardous chemical substances.
1.2.2 Aspects excluded from scope
Addition:
Add the following item and note:
g aa) 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:
Addition:
Add the following references:
ISO 14971:2000, Medical devices – Application of risk management to medical devices
ISO 18113-5, In vitro diagnostic medical devices – Information supplied by the manufacturer

(labelling) – In vitro diagnostic instruments for selftesting
ISO 13857, Safety of machinery – Safety distances to prevent hazard zones being reached by
upper and lower limbs
3 Terms and definitions
This clause of Part 1 is applicable except as follows:
3.1 Equipment and states of equipment
Addition:
Add the following terms and definitions:

– 8 – IEC 61010-2-101:2015 RLV © IEC 2015

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

[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
3.1.101
SAMPLE ZONE
area where OPERATOR access is typically unintended; the inside of this zone presents

mechanical HAZARDS and a more likely probability of biohazardous human skin puncture
3.1.102
LOADING ZONE
area of automated equipment where an OPERATOR handles sample or reagent material.
3.5.12 RESPONSIBLE BODY
Addition:
Add the following note:
NOTE 1 This is not the European Community responsible authority.

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.
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 symbols to Table 1:

– 10 – IEC 61010-2-101:2015 RLV © IEC 2015

Number Symbol Publication Description

Background colour
– yellow optional;
Biohazard
Symbol colour
101 ISO 7000- 0659 (2004-01)
Biological RISKS
– optional;
Outline / outline colour
– black optional;
EN 980, subclause 4
102 Batch code
ISO 7000- 2492 (2004-01)
5.1.2 Identification
Replacement:
Replace the text by the following:
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;
NOTE 1 National regulation may require more details on the address than required in a).
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.
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 consumable parts, expressed as the year, the month and (where
relevant) the day, in that order.
3) instructions for use shall require that the OPERATOR only use consumables that are
within their expiration date. Where this is required by regulation, the name and address
of the authorized representative of the manufacturer.
NOTE 2 For example, in the European Union this is the natural or legal person as established within
the European Community.
5.1.5 TERMINALS, connections and operating devices
Addition:
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).

Conformity is checked by inspection.
Addition:
Add the following subclause:
5.1.101 Transport and storage
Packaging of equipment shall be labelled to indicate any special conditions for transport or
storage (see 5.4.102).
Conformity is checked by inspection.
5.2 Warning markings
Replacement:
Replace the fifth first paragraph by the following four 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.
Containers or bags for 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), 5.1.5.2 d), 5.1.5.101, 6.1.2 b), 6.5.1.2 g),

6.6.2, 7.2 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 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 encountered in NORMAL USE, including cleaning and
decontaminating agents specified by the manufacturer.
Addition:
Add after the first second paragraph the following paragraph:

– 12 – IEC 61010-2-101:2015 RLV © IEC 2015

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 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 optional be used).
5.4.1 General
Deletion:
Delete the 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 subclause 5.4.3 by the following:
5.4.3 Equipment transportation, installation and assembly instructions
Documentation for the RESPONSIBLE BODY shall include the following if applicable:
a) instructions for transportation after delivery to the RESPONSIBLE BODY;
b) floor loading requirements;
NOTE Mass and dimensions are sufficient information for floor loading.
c) individual weights mass of principal heavy subassemblies units;
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) 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 switch or circuit-breaker (see 6.11.2.1) and external

overcurrent protection devices (see 9.6.1) and a recommendation that the switch or

circuit-breaker be near the equipment 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:
Replace the first paragraph text by the following:
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 consumable 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 to deal
with a HAZARD resulting from equipment spills, lock-ups, container breakage and similar
malfunctions;
g) instructions and recommendations for cleaning and decontamination, with materials
recommended (see 11.2);
h) instructions for the disposal of hazardous waste;
i) if NORMAL USE involves the handling of hazardous chemical substances, instructions on
correct use and any need for training or personal protection measures;
j) Appropriate instruction to use personal protective equipment (e.g. gloves, gowns) where
there could be contact with the skin when handling potentially infectious substances or
surfaces (such as human samples or reagents), the need to use protective gloves or other
protective means;
k) Appropriate instructions and requirements for protection of the mouth, nose or eyes shall

be given where the equipment could emit hazardous aerosol vapours in NORMAL USE;
l) Appropriate instructions and requirements for protective devices, such as protective
glasses shall be given where potentially hazardous visible or invisible radiation could be
emitted;
m) 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.
detailed instructions about RISK reduction procedures relating to flammable liquids (see
9.5 c));
n) details of methods of reducing the RISKS of burns from surfaces permitted to exceed the
temperature limits of 10.1.
o) Appropriate warnings to reduce RISK during loading and unloading of samples and
reagents (see 7.3.102)
p) Instructions for the RESPONSIBLE BODY to ensure that all retaining hardware (e.g screws,
fasteners) are in place on removable PROTECTIVE BARRIERS, and the removable PROTECTIVE
BARRIERS are in place on the instrument during normal operation.

– 14 – IEC 61010-2-101:2015 RLV © IEC 2015

q) A statement that, if a TOOL is required to remove a fixed PROTECTIVE BARRIER and/or

ENCLOSURE guarding a SAMPLE ZONE, access to that tool should be controlled by the

RESPONSIBLE BODY.
r) A statement listing the tools to be controlled by the RESPONSIBLE BODY.

NOTE 2 Information on decontaminants their use, dilution and potential application is contained in the Laboratory
Biosafety Manual, published by the World Health Organization and the Biosafety in Microbiological and Biomedical
Laboratories, published by Centers for Disease Control and Prevention and National Institutes of Health,

Washington. There are also national guidelines that cover these areas.

NOTE 3 Cleaning and decontamination may be necessary as a safeguard when equipment and their accessories
are maintained, repaired, or transferred. Preferably manufacturers should provide a format for the RESPONSIBLE

BODY 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.
Addition:
Add the following subclauses:
5.4.4.101 Instructions for use, self-test IVD medical equipment
Instructions for use of self-test IVD medical equipment are given in annex BB shall comply
with ISO 18113-5.
Conformity is checked by inspection of the documentation.
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, or appropriate contact information shall be provided
in the documentation.
NOTE Regional or international requirements can apply.
Conformity is checked by inspection of the documentation.
5.4.102 Transport and storage
The manufacturer shall specify the conditions for transport and storage of the equipment. The
documentation shall contain a specification of the permissible environmental conditions for
transport and storage which. Essential information shall be repeated on the outside of the
packaging of the equipment (see 5.1) package using appropriate symbols (see 5.1.101).

When the manufacturer assumes responsibility for delivery and installation the above is not
required in the documentation.
Compliance is checked by inspection.
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:

7.3.1 General
Replacement:
Replace the second sentence as follows:

The conditions specified in 7.3.4, 7.3.5, and 7.3.101 are considered to represent a tolerable

level.
Replace the conformity statement as follows:

Conformity is checked as specified in 7.3.2, 7.3.3, 7.3.4, 7.3.5, 7.3.101, and Clause 17 as
applicable.
7.3.2 Exceptions
Replacement:
Replace item b) 3) text 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 to to the list:
b) 4) There are OPERATOR maintenance instructions that specify safe maintenance
procedures.
7.3.3 RISK assessment for mechanical HAZARDS to body parts
Replacement:
Replace text by the following:
If equipment is specified by the manufacturer for continuous loading of sample and reagent
materials and associated HAZARDS in the SAMPLE ZONE are solely caused by the sample and/or
reagent probes 7.3.101 applies specifically for the SAMPLE ZONE. Subclause 7.3.101 does not

apply to self-testing and point of care equipment.
RISKS shall be reduced to a tolerable level by at least the applicable minimum protective
measure of Table 12, taking into account the severity, probability of exposure and possibility
of avoiding the HAZARD.
Conformity is checked by evaluation of the RISK assessment documentation to ensure that the
RISKS have been eliminated or that only TOLERABLE RISKS remain.
Table 12 – Protective measures against mechanical HAZARDS to body parts
Replacement:
Replace the text of item B by the following text:
Moderate measures; emergency switches, PROTECTIVE BARRIERS or covers removable only
with a TOOL, distances (see ISO 13857), or separations (see ISO 13854 or EN 349).

– 16 – IEC 61010-2-101:2015 RLV © IEC 2015

Addition:
Add the following subclause:
7.3.101 SAMPLE ZONE
Equipment with a SAMPLE ZONE shall comply with the requirements of one or more of the

following:
aa) PROTECTIVE BARRIER or
bb) all following measures apply:

1) The minimum maintained gap between LOADING ZONE and SAMPLE ZONE is 120 mm.
2) Unintentional contact between OPERATOR and sample/reagent pipettor is unlikely.
3) The area between LOADING ZONE and SAMPLE ZONE is marked with symbol 14 and
symbol 101 of table 1 (see 5.4.4 o)), or if not visible by the OPERATOR the marking shall
be located visible and close to the area.
8 Mechanical resistance to shock and impact Resistance to mechanical
stresses
This clause of part 1 is applicable except as follows:
Addition:
Additional subclause:
8.1 General
Replacement:
Replace the text of item 3) by the following:
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.
Addition:
Add the following subclause:
8.101 Transport and storage
When packed delivered in the manufacturer’s packaging, equipment shall not cause a HAZARD
during NORMAL USE after transport or storage in the conditions specified by the manufacturer
(see 5.1.101 and 5.4.101).
If the manufacturer assumes responsibility for delivery and installation, the above requirement
is met without inspection of test records.
Conformity is checked by inspection of records of transport tests performed by the
manufacturer.
NOTE Guidance on tests is given in ASTM D4169, and in the publications of the International Safe Transport
Association (ISTA).
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.
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:
– 18 – IEC 61010-2-101:2015 RLV © IEC 2015

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 used in the equipment, 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 infectious due to the samples or reagents used shall be
prominently marked with symbol 101 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.
Symbol 101 of Table 1 shall be marked on containers or bags for biohazardous waste material
which can be removed from the equipment during NORMAL USE, and near any biohazardous
drain connection.
Equipment that can be hazardous due to the use of hazardous substances shall be marked
with the appropriate international symbol, or (if none is available) symbol 14 of Table 1.
14 Components and subassemblies
This clause of Part 1 is applicable except as follows:
14.3 Over-temperature protection devices

Addition:
Add the following paragraph after the second paragraph:
Over-temperature protection devices in self-test IVD medical equipment shall not be self-
resetting.
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  Measuring circuits HAZARDS resulting from application

This clause of Part 1 is applicable except as follows:

16.2 Ergonomic aspects
Replacement:
Replace the note by the following note:
NOTE RISK assessment procedures for ergonomics can be found in IEC 62366, EN 894-2, EN 894-3, ISO 9241,
SEMI S8 and other documents. Not all of the requirements in these documents will be applicable to equipment
within the scope of this standard.
17 RISK assessment
This clause of Part 1 is replaced as follows:
Replacement:
RISK assessment shall be carried out and documented using the requirements of ISO 14971
for HAZARDS not addressed in this standard and Part 1.
Conformity is checked by evaluation of the RISK assessment documentation to assure that the
RISKS have been eliminated or that only TOLERABLE RISKS remain.
Annexes
The annexes of Part 1 are applicable except as follows:
Additions:
Annex H L
(informative)
Index of defined terms
Addition:
Add the following defined terms to the list:
HARM . 3.101
MARKING . 3.106
PERMANENTLY AFFIXED . 3.105
REASONABLY FORESEEABLE MISUSE . 3.104
RISK .
...