Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials

IEC 61010-2-040:2020 is available as IEC 61010-2-040:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC 61010-2-040:2020 specifies safety requirements for electrical equipment intended for sterilization, washing, and disinfection of medical materials in the medical, veterinary, pharmaceutical and laboratory fields, when used under the environmental conditions of 1.4. Examples of such equipment include the following:
- sterilizers and disinfectors using steam and/or hot water as the sterilant;
- sterilizers and disinfectors using toxic gas, toxic aerosol or toxic vapour as the sterilant;
- sterilizers and disinfectors using hot air or hot inert gas as the sterilant; and
- washer-disinfectors.
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:
- it is established on the basis of the third edition (2010) of IEC 61010‑1 and its Amendment 1 (2016);
- added tolerance for stability of a.c. voltage test equipment to 6.8.3.1;
- the status of a Group Safety Publication has been removed (this does not change the technical requirements in the document).

Exigences de sécurité pour appareils électriques de mesurage, de régulation et de laboratoire - Partie 2-040: Exigences particulières pour stérilisateurs et laveurs désinfecteurs utilisés pour traiter le matériel médical

IEC 61010-2-040:2020 est disponible sous forme de IEC 61010-2-040:2020 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.L'IEC 61010-2-040:2020 définit les exigences de sécurité pour les appareils électriques destinés à la stérilisation, au lavage et à la désinfection du matériel médical dans les domaines médicaux, vétérinaires, pharmaceutiques et de laboratoire, lorsqu'ils sont utilisés dans les conditions d'environnement de 1.4. Exemples de ce type d'appareils:
- les stérilisateurs et désinfecteurs utilisant la vapeur et/ou l'eau chaude comme agent stérilisant;
- les stérilisateurs et désinfecteurs utilisant le gaz toxique, l'aérosol toxique, ou la vapeur toxique comme agent stérilisant;
- les stérilisateurs et désinfecteurs utilisant de l'air chaud ou du gaz inerte chaud comme agent stérilisant; et
- les laveurs désinfecteurs.
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:
- elle est établie sur la base de la troisième édition (2010) de l'IEC 61010-1 et son Amendement 1 (2016);
- tolérance ajoutée pour la stabilité des matériels d'essai sous tension alternative spécifiés en 6.8.3.1;
- le statut de publication groupée de sécurité a été supprimé (ce qui ne modifie pas les exigences techniques du document).

General Information

Status
Published
Publication Date
13-May-2020
Current Stage
PPUB - Publication issued
Completion Date
14-May-2020
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IEC 61010-2-040
Edition 3.0 2020-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Safety requirements for electrical equipment for measurement, control, and
laboratory use –
Part 2-040: Particular requirements for sterilizers and washer-disinfectors used
to treat medical materials
Exigences de sécurité pour appareils électriques de mesurage, de régulation
et de laboratoire –

Partie 2-040: Exigences particulières pour sterilisateurs et laveurs desinfecteurs

utilisés pour traiter le matériel médical
IEC 61010-2-040:2020-05(en-fr)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
IEC 61010-2-040
Edition 3.0 2020-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Safety requirements for electrical equipment for measurement, control, and
laboratory use –
Part 2-040: Particular requirements for sterilizers and washer-disinfectors used
to treat medical materials
Exigences de sécurité pour appareils électriques de mesurage, de régulation
et de laboratoire –

Partie 2-040: Exigences particulières pour sterilisateurs et laveurs desinfecteurs

utilisés pour traiter le matériel médical
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 19.080; 71.040.10 ISBN 978-2-8322-8301-1

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 61010-2-040:2020 © IEC 2020
CONTENTS

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

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

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

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

4 Tests ............................................................................................................................... 7

5 Marking and documentation ............................................................................................. 9

6 Protection against electric shock ................................................................................... 14

7 Protection against mechanical HAZARDS and against HAZARDS related to

mechanical functions ..................................................................................................... 15

8 Resistance to mechanical stresses ................................................................................ 19

9 Protection against the spread of fire .............................................................................. 19

10 Equipment temperature limits and resistance to heat ..................................................... 20

11 Protection against HAZARDS from fluids and solid foreign objects ................................... 21

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

ultrasonic pressure ........................................................................................................ 24

13 Protection against liberated gases, substances, explosion and implosion ...................... 25

14 Components and subassemblies ................................................................................... 30

15 Protection by interlocks ................................................................................................. 32

16 HAZARDS resulting from application ................................................................................ 32

17 RISK assessment ........................................................................................................... 32

Annexes ............................................................................................................................... 33

Annex G (informative) Leakage and rupture from fluids under pressure ............................... 33

Annex L (informative) Index of defined terms ....................................................................... 34

Bibliography .......................................................................................................................... 35

---------------------- Page: 4 ----------------------
IEC 61010-2-040:2020 © IEC 2020 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR
MEASUREMENT, CONTROL, AND LABORATORY USE –
Part 2-040: Particular requirements for STERILIZERS and
WASHER-DISINFECTORS used to treat medical materials
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.

International Standard IEC 61010-2-040 has been prepared by IEC technical committee 66:

Safety of measuring, control and laboratory equipment.

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:

a) it is established on the basis of the third edition (2010) of IEC 61010‑1 and its

Amendment 1 (2016);
b) added tolerance for stability of a.c. voltage test equipment to 6.8.3.1;
---------------------- Page: 5 ----------------------
– 4 – IEC 61010-2-040:2020 © IEC 2020

c) the status of a Group Safety Publication has been removed (this does not change the

technical requirements in the document).
The text of this International Standard is based on the following documents:
CDV Report on voting
66/699/CDV 66/716/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.

The reader's attention is drawn to the fact that Annex G lists all of the "in-some-country"

clauses on differing practices of a less permanent nature relating to the subject of this

standard.

A list of all parts in 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 2-040 is to be used in conjunction with IEC 61010-1. It was established on the basis

of the third edition (2010) of IEC 61010-1 and its Amendment 1 (2016), hereinafter referred to

as Part 1.

This Part 2-040 supplements or modifies the corresponding clauses in Part 1 so as to convert

that publication into the IEC standard: Particular requirements for STERILIZERS and WASHER-

DISINFECTORS used to treat medical materials.

Where a particular subclause of Part 1 is not mentioned in this Part 2-040, that subclause

applies as far as is reasonable. Where this Part 2-040 states "addition", "modification",

"replacement", or "deletion", the relevant requirement, test specification or note in Part 1 shall

be adapted accordingly.
In this standard:
1) the following print types are used:
– requirements: in roman type;
– NOTES: in small roman type;
– conformity and tests: in italic type;
– terms used throughout this standard which have been defined in Clause 3: SMALL
ROMAN CAPITALS.

2) subclauses, figures, and tables 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 61010-2-040:2020 © IEC 2020 – 5 –
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR
MEASUREMENT, CONTROL, AND LABORATORY USE –
Part 2-040: Particular requirements for STERILIZERS and
WASHER-DISINFECTORS used to treat medical materials
1 Scope and object
This clause of Part 1 is applicable except as follows:
1.1.1 Equipment included in scope
Replacement:
Replace the existing text with the following:

This part of IEC 61010 specifies safety requirements for electrical equipment intended for

sterilization, washing, and disinfection of medical materials in the medical, veterinary,

pharmaceutical and laboratory fields, when used under the environmental conditions of 1.4.

Examples of such equipment include the following:
a) STERILIZERS and disinfectors using steam and/or hot water as the sterilant;

b) STERILIZERS and disinfectors using toxic gas, toxic aerosol or toxic vapour as the sterilant;

c) STERILIZERS and disinfectors using hot air or hot inert gas as the sterilant; and

d) WASHER-DISINFECTORS.
1.1.2 Equipment excluded from scope
Addition:
Add the following note to item f):

NOTE IEC 60601-1:2005, 3.63, defines "medical electrical equipment" as follows (notes to entry are omitted):

Electrical equipment, having an applied part or transferring energy to or from the patient or detecting such energy

transfer to or from the patient and which is:
a) provided with not more than one connection to a particular supply MAINS; and
b) intended by its manufacturer to be used:
1) in the diagnosis, treatment, or monitoring of a patient; or
2) for compensation or alleviation of disease, injury or disability.
Addition:
Add the following new second paragraph after the lettered list:
This document does not apply to the following types of equipment:

aa) equipment for use in hazardous atmospheres (see IEC 60079); however this document

does apply to an atmosphere created inside equipment by a flammable sterilizing
agent (see 13.2.101 and 13.2.102);

bb) laboratory equipment for the heating of materials for purposes other than sterilization

or disinfection (see IEC 61010-2-010);
---------------------- Page: 7 ----------------------
– 6 – IEC 61010-2-040:2020 © IEC 2020
cc) laundry equipment (see IEC 60335-2-4, IEC 60335-2-7, IEC 60335-2-11, and
ISO 10472 (all parts)), unless designed for disinfecting medical materials;
dd) dishwashers (see IEC 60335-2-5 and IEC 60335-2-58).
1.2.1 Aspects included in scope
Replacement:
Replace item g) with the following new text:

g) liberated gases (including the non-intentional escape of toxic gas), pathogenic

substances, explosion and implosion (see Clause 13).
1.2.2 Aspects excluded from scope
Addition:
Add the following two new items:

aa) special requirements for protection against chemical and high-risk micro-biological

HAZARDS associated with the LOAD;
PRESSURE VESSELS.
bb) general requirements for the design of calorifiers, shell boilers and

NOTE National and other regulations or codes apply for the safety of calorifiers, shell boilers and

PRESSURE VESSELS (see 14.101).
2 Normative references
This clause of Part 1 is applicable except as follows:
Addition:
Add the following new references:

IEC 61770, Electric appliances connected to the water mains – Avoidance of backsiphonage

and failure of hose-sets
ISO 3585, Borosilicate glass 3.3 – Properties

ISO 4126-1, Safety devices for protection against excessive pressure – Part 1: Safety valves

ISO 4126-2, Safety devices for protection against excessive pressure – Part 2: Bursting disc

safety devices
3 Terms and definitions
This clause of Part 1 is applicable except as follows:
3.2 Parts and accessories
Addition:
Add the following new terms and definitions:
3.2.101
CHAMBER
LOAD
part of the equipment which receives the
---------------------- Page: 8 ----------------------
IEC 61010-2-040:2020 © IEC 2020 – 7 –
3.2.102
LOAD

equipment or materials put into a CHAMBER to be processed through an OPERATING CYCLE

3.2.103
STERILIZER

equipment designed to achieve sterilization which comprises a series of actions or operations

needed to achieve the specified requirements for sterility
3.2.104
PRESSURE VESSEL

assembly comprising the CHAMBER, the jacket (if fitted), doors, and all other components in

permanent open connection with the CHAMBER

Note 1 to entry: The PRESSURE VESSEL does not include parts from which it can be isolated, such as steam

generators, pipework, and fittings.
3.2.105
OPERATING CYCLE

complete set of stages of the process that is carried out in a specified sequence

Note 1 to entry: Loading and unloading are not part of the OPERATING CYCLE.
3.2.106
WASHER-DISINFECTOR

equipment intended to clean and disinfect medical devices and other articles used in the

context for example of medical, dental, pharmaceutical and veterinary practice
3.5 Safety terms
3.5.2
HAZARD
Addition:
Add the following new Note 1 to entry:

Note 1 to entry: In the context of this document, the term HAZARD relates only to potential sources of harm to the

OPERATOR and surroundings (see 1.2.1), and does not include potential sources of harm related to the efficacy of

the process.
3.5.11
OPERATOR
Addition:
Add the following Note 1 to entry:

Note 1 to entry: An OPERATOR includes persons installing, operating, adjusting, maintaining, cleaning, repairing or

moving equipment.
4 Tests
This clause of Part 1 is applicable except as follows:
4.3.2.4 Covers and removable parts
Addition:
Add the following new second paragraph:
---------------------- Page: 9 ----------------------
– 8 – IEC 61010-2-040:2020 © IEC 2020

Covers including panels and control box ENCLOSURES which do not require the use of a TOOL

for removal need not be removed if they have interlocks which meet the requirements of

Clause 15, and which automatically de-activate all parts which would otherwise present a

HAZARD when the cover is opened.
4.3.2.12 Duty cycle
Addition:
Add the following new second paragraph:

Equipment which can be operated continuously shall also be tested without any interval

between consecutive OPERATING CYCLES.
Addition:
Add the following new subclause:
4.3.2.101 Non-electrical supplies and services

Non-electrical supplies and services shall be set to the least favourable RATED settings.

4.4.2.1 General
Replacement:
Replace the first sentence of the first paragraph with the following sentence:

Fault conditions shall include those specified in 4.4.2.2 to 4.4.2.14 and 4.4.2.101 to 4.4.2.103.

4.4.2.5 Motors
Addition:
Add the following new second paragraph:

If it is impracticable to test a motor when installed, a separate identical motor can be tested

but it shall be tested in the same conditions that exist inside the equipment.
4.4.2.13 Interlocks
Addition:
Add the following new second paragraph:

If an interlock provides protection against accidental contact with a hazardous substance, the

interlock is tested using a non-hazardous substance.
Addition:
Add the following three new subclauses:
4.4.2.101 Pressure controllers

Pressure controllers, except for overpressure safety devices meeting the requirements of

11.7.4, shall be overridden to supply the service continuously.
---------------------- Page: 10 ----------------------
IEC 61010-2-040:2020 © IEC 2020 – 9 –
4.4.2.102 Failure, or partial failure, of the MAINS supply

The equipment shall be operated at 90 % and 110 % of the RATED voltage for one cycle. The

voltage shall then be set to 90 % of the RATED voltage for 5 min. The voltage shall then be

reduced gradually at a rate of approximately 10 V per min until the equipment fails to operate

normally. The voltage shall then be reset to the RATED voltage with the equipment still

switched on.
4.4.2.103 Failure, or partial failure, of other supplies and services

In turn, each non-electrical supply and service shall be interrupted, or partially interrupted,

whichever is less favourable.

NOTE Examples include air, steam, feedwater, sterilant gas, detergent, disinfectant, and systems for drainage,

exhaust, and ventilation.
5 Marking and documentation
This clause of Part 1 is applicable except as follows:
5.1.2 Identification
Replacement:
Replace the existing text by the following:
The equipment shall as a minimum be marked with the following:
a) the name and address of the manufacturer;

b) any additional markings required by national and local regulations, including the name and

address of the manufacturer's authorized representative in the country of intended use;

c) a marking that uniquely identifies the individual unit of manufacture such as a serial

number;
d) year and place of manufacture, if different from manufacturer's address;
e) model identification;
f) designated purpose of the equipment.
Conformity is checked by inspection
Addition:
Add the following two new subclauses:
5.1.101 Overpressure protective device

The device (see 11.7.4) shall be marked with the name of the manufacturer of the device, the

model number, and the pressure to which it is set. If a bursting disc is located between the

CHAMBER and the overpressure safety device, the disc shall be marked with its specified

bursting pressure and associated temperature.
NOTE National, local regulations and other codes can apply.
5.1.102 PRESSURE VESSELS and shell boilers

Attention is drawn to the existence of national and local regulations that can require additional

markings.
---------------------- Page: 11 ----------------------
– 10 – IEC 61010-2-040:2020 © IEC 2020
5.2 Warning markings
Addition:
Add the following new second paragraph:
Warning and caution symbols shall be at least 10 mm high.
5.4.1 General
Replacement:

Replace the first paragraph (excluding lettered list) by the following new paragraph:

The following documentation necessary for safety purposes, as needed by the OPERATOR or

RESPONSIBLE BODY, shall be marked with its date of issue or revision status and be provided

with the equipment:
Add the following new paragraph after item h) of the lettered list:

If NORMAL USE involves the handling of a hazardous substance, documentation shall include

information on constituents, correct storage, use, and safe disposal.
Replace Note 2 by the following new Note 2:

NOTE 2 Attention is drawn to the existence of national and local regulations that can apply to the documentation.

Add a new paragraph directly before the conformity statement:
Marking, information, and language shall:
1) comply with regulations applying in the country of intended use;
NOTE 3 ISO 15223-2 offers guidance for equipment classified as a medical device.

2) include instructions for the disposal of the equipment, its accessories and its packaging;

3) give due consideration to the technical knowledge, education and training of different

OPERATOR categories;

4) not contradict information contained in documentation provided to describe the equipment.

5.4.2 Equipment RATINGS
Addition:
Add the following new item to the lettered list after item f):

aa) for each non-electrical service, if applicable, the RATED ranges of temperature,

pressure and flow-rate.
5.4.3 Equipment installation
Replacement:
Replace items a) to g) with the following:
a) location and mounting instructions;
b) space required for safe and efficient maintenance;
c) individual weights of principal heavy subassemblies;
---------------------- Page: 12 ----------------------
IEC 61010-2-040:2020 © IEC 2020 – 11 –
d) overall weight and floor loading requirements;
e) unpacking and assembly instructions (see also 7.108);

f) MAINS supply requirements and connections, including the temperature rating of any cable

required to meet the requirements in 5.1.8;
g) for PERMANENTLY CONNECTED EQUIPMENT:
1) supply wiring requirements;

2) requirements for any external switch or circuit-breaker (see 6.11.3.1) and external

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

circuit-breaker be near the equipment;
h) ventilation requirements (see 11.101, 13.1.103.1, and 13.1.101);
i) drainage requirements (see 11.101);
j) instructions for protective earthing;
k) instructions relating to sound level (see 12.5.1);

l) requirements for special services, for example air, feedwater, cooling liquid;

m) requirements related to hazardous gas atmospheres (see Clause 13);

n) instructions to position the equipment so that it is not difficult to operate the disconnecting

device;

o) instructions relating to the handling and containment of hazardous substances, including

any need for additional equipment that can be required to control emissions (see 13.1);

HAZARDS caused by liquids or hot items falling from the equipment
p) instructions relating to
(see 9.1);

q) requirements for material used in the installation of the equipment and which can come

into contact with sterilant (see 13.1.103.4 and 13.2.101);
r) instructions for ambient illumination (see also 11.102);
NOTE ISO 12100 and EN 1837 give guidance on lighting.
s) instructions relating to heat emission.
Addition:
Add the following new subclause:
5.4.3.101 Special systems

Installation instructions shall include details of the following special systems, if needed to

protect against possible HAZARDS:

a) non-recirculating ventilation system for the room in which the equipment is installed (also

see 13.1.103.3);

Such a ventilation system shall normally give a minimum of 10 air changes per hour, but

for large installations this may need to be increased.
...

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