EN 61010-2-040:2005

SLOVENSKI STANDARD
01-februar-2006
1DGRPHãþD
SIST EN 61010-2-041:1999
SIST EN 61010-2-042:1999
SIST EN 61010-2-043:1999
SIST EN 61010-2-045:2002
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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
Sicherheitsbestimmungen für elektrische Mess-, Steuer-, Regel- und Laborgeräte -- Teil
2-040: Besondere Anforderungen an Sterilisatoren und Reinigungs-Desinfektionsgeräte
für die Behandlung medizinischen Materials
Règles 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
Ta slovenski standard je istoveten z: EN 61010-2-040:2005
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
19.080 (OHNWULþQRLQHOHNWURQVNR Electrical and electronic
SUHVNXãDQMH testing
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 61010-2-040
NORME EUROPÉENNE
EUROPÄISCHE NORM July 2005
ICS 19.080; 71.040.10 Supersedes EN 61010-2-041:1996 & EN 61010-2-042:1997 &
EN 61010-2-043:1997 & EN 61010-2-045:2000

English version
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 61010-2-040:2005)
Règles de sécurité pour appareils Sicherheitsbestimmungen für elektrische
électriques de mesurage, de régulation Mess-, Steuer-, Regel- und Laborgeräte
et de laboratoire Teil 2-040: Besondere Anforderungen an
Partie 2-040: Exigences particulières Sterilisatoren und Reinigungs-
pour stérilisateurs et laveurs désinfecteurs Desinfektionsgeräte für die Behandlung
utilisés pour traiter le matériel médical medizinischen Materials
(CEI 61010-2-040:2005) (IEC 61010-2-040:2005)

This European Standard was approved by CENELEC on 2005-06-01. CENELEC members are bound to
comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and
notified to the Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden,
Switzerland and United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels

© 2005 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.

Ref. No. EN 61010-2-040:2005 E

Foreword
The text of document 66/353/FDIS, future edition 1 of IEC 61010-2-040, prepared by IEC TC 66,
Safety of measuring, control, and laboratory equipment, was submitted to the IEC-CENELEC parallel
vote and was approved by CENELEC as EN 61010-2-040 on 2005-06-01.
This European Standard supersedes EN 61010-2-041:1996 + corrigendum September 1996,
EN 61010-2-042:1997, EN 61010-2-043:1997 and EN 61010-2-045:2000.
This Part 2-040 is to be used in conjunction with EN 61010-1:2001, Safety requirements for electrical
equipment for measurement, control and laboratory use – Part 1: General requirements.
Consideration may be given to future editions of, or amendments to, EN 61010-1.
This Part 2-040 supplements or modifies the corresponding clauses of EN 61010-1:2001 so as to
convert it into the European Standard "Safety requirements for sterilizers and washer-disinfectors
used to treat medical materials".
Where a particular clause or subclause of Part 1 is not mentioned in this Part 2-040, that clause or
subclause applies as far as is reasonable. Where this part states "addition", "modification",
"replacement" or "deletion", the relevant text of Part 1 is to be adapted accordingly.
In this standard:
1) the following print types are used:
– requirements: in roman type;
– NOTES: in small roman type;
– conformity and tests: 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.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2006-03-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2008-06-01
Annex ZA has been added by CENELEC.
__________
- 3 - EN 61010-2-040:2005
Endorsement notice
The text of the International Standard IEC 61010-2-040:2005 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
IEC 60335-2-4 NOTE Harmonized as EN 60335-2-4:2002 (not modified).
IEC 60335-2-5 NOTE Harmonized as EN 60335-2-5:2003 (modified).
IEC 60335-2-7 NOTE Harmonized as EN 60335-2-7:2003 (modified).
IEC 60335-2-11 NOTE Harmonized as EN 60335-2-11:2003 (modified).
IEC 60335-2-58 NOTE Harmonized as EN 60335-2-58:2005 (modified).
IEC 60601-1 NOTE Harmonized as EN 60601-1:1990 (not modified).
IEC 61010-2-010 NOTE Harmonized as EN 61010-2-010:2003 (not modified).
IEC 61508 NOTE Harmonized in EN 61508 series (not modified).
ISO 10472 NOTE Harmonized in EN ISO 10472 series (not modified).
__________
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
NOTE Where an international publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
Publication Year Title EN/HD Year
IEC 60079 (mod) Series Electrical apparatus for explosive gas EN 60079 Series
atmospheres
1) 2)
IEC 61770 - Electric appliances connected to the EN 61770 1999
water mains - Avoidance of
backsiphonage and failure of hose-sets

1)
ISO 3585 - Borosilicate glass 3.3 - Properties - -

1)
ISO 6718 - Bursting discs and bursting disc devices - -

1)
Undated reference.
2)
Valid edition at date of issue.

NORME CEI
INTERNATIONALE
IEC
61010-2-040
INTERNATIONAL
Première édition
STANDARD
First edition
2005-04
PUBLICATION GROUPÉE DE SÉCURITÉ
GROUP SAFETY PUBLICATION
Règles 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
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 2005 Droits de reproduction réservés  Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in any
utilisée sous quelque forme que ce soit et par aucun procédé, form or by any means, electronic or mechanical, including
électronique ou mécanique, y compris la photocopie et les photocopying and microfilm, without permission in writing from
microfilms, sans l'accord écrit de l'éditeur. the publisher.
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Telephone: +41 22 919 02 11 Telefax: +41 22 919 03 00 E-mail: inmail@iec.ch Web: www.iec.ch
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Pour prix, voir catalogue en vigueur
For price, see current catalogue

61010-2-040  IEC:2005 – 3 –
CONTENTS
FOREWORD.5

1 Scope and object.9
2 Normative references .11
3 Terms and definitions .11
4 Tests .13
5 Marking and documentation.15
6 Protection against electric shock .25
7 Protection against mechanical HAZARDS.27
7 Protection against mechanical HAZARDS and against HAZARDS related to
mechanical functions .27
8 Mechanical resistance to shock and impact .35
9 Protection against the spread of fire .35
10 Equipment temperature limits and resistance to heat.35
11 Protection against HAZARDS from fluids .37
12 Protection against radiation, including laser sources, and against sonic and
ultrasonic pressure .43
13 Protection against liberated gases, explosion and implosion.43
14 Components .57
15 Protection by interlocks .59
16 Test and measurement equipment.59

Annexes .61
Annex G (informative) Leakage and rupture from fluids under pressure .61
Annex H (informative) Index of defined terms.61

Bibliography.63

61010-2-040  IEC:2005 – 5 –
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
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 provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
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.
It has the statute of a group safety publication in accordance with IEC Guide 104.
This document consolidates the requirements of four standards, IEC 61010-2-041, IEC 61010-
2-042, IEC 61010-2-043 and IEC 61010-2-045, which are withdrawn, and aligns them with
the second edition (2001) of IEC 61010-1:Safety requirements for electrical equipment for
measurement, control, and laboratory use – Part 1: General requirements.

61010-2-040  IEC:2005 – 7 –
The text of this standard is based on the following documents:
FDIS Report on voting
66/353/FDIS 66/358/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.
This Part 2-040 is intended to be used in conjunction with IEC 61010-1. It was established on
the basis of the second edition (2001) of that standard. Consideration may be given to future
editions of, or amendments to, IEC 61010-1.
This Part 2-040 supplements or modifies the corresponding clauses in IEC 61010-1 so as to
convert that publication into the IEC standard Safety 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, 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 small 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.
The committee has decided that the contents of this publication will remain unchanged until
the maintenance result 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.
61010-2-040  IEC:2005 – 9 –
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:
This International Standard 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 are:
a) STERILIZERS and disinfectors using steam;
b) STERILIZERS and disinfectors using toxic gas, toxic aerosol or toxic vapour;
c) STERILIZERS and disinfectors using hot air or hot inert gas, and
d) washer disinfectors.
1.1.2 Equipment excluded from scope
Add the following note to item g)
NOTE IEC 60601-1(definition 2.2.15 modified) defines medical electrical equipment as follows:
Electrical equipment, provided with not more than one connection to a particular supply MAINS and intended by its
manufacturer to be used in the diagnosis, treatment, or monitoring of a patient; and that makes physical or
electrical contact with the patient or transfers energy to or from the patient or detects such energy transfer to or
from the patient.
Add the following new second paragraph:
This standard also does not apply to the following types of equipment:
aa) equipment for use in hazardous gas atmospheres (see IEC 60079) except for an
atmosphere created inside equipment by the use of a flammable sterilizing agent (see
13.0);
bb) environmental cabinets (see IEC 61010-1);
cc) laboratory equipment for the heating of materials for other purposes than sterilization or
disinfection (see IEC 61010-2-010);
dd) laundry equipment (see IEC 60335, Parts 2-4, 2-7, and 2-11, and ISO 10472), unless
designed for disinfecting medical materials;
ee) dishwashers (see IEC 60335, Parts 2-5 and 2-58).

61010-2-040  IEC:2005 – 11 –
1.2.1 Aspects included in scope
Replacement:
Replace item g) and the note by the following new text and note:
g) liberated gases (including the non-intentional escape of toxic gas), pathogenic
substances, explosion and implosion (see Clause 13).
NOTE Attention is drawn to the existence of additional requirements which may be specified by national authorities
responsible for the health and safety of labour forces. In particular, national and other regulations or codes apply
for the safety of automatic loading and unloading systems.
1.2.2 Aspects excluded from scope
Add the following two new items:
aa) special requirements for protection against chemical and high-risk micro-biological
HAZARDS associated with the LOAD;
bb) general requirements for the design of calorifiers, shell boilers and PRESSURE VESSELS.
NOTE National and other regulations or codes apply for the safety of calorifiers, shell boilers and PRESSURE
VESSELS.
2 Normative references
This clause of Part 1 is applicable except as follows:
Additions:
IEC 60079 (all parts), Electrical apparatus for explosive gas atmospheres
IEC 61770, Electrical appliances connected to the water MAINS – Avoidance of back-
siphonage and failure of hose-sets
ISO 3585, Borosilicate glass 3.3 – Properties
ISO 6718, Bursting discs and bursting disc devices

3 Terms and definitions
This clause of Part 1 is applicable except as follows:
Addition:
3.2.101
CHAMBER
the part of the equipment which receives the LOAD
3.2.102
LOAD
equipment or materials put into a CHAMBER to be processed through an OPERATING CYCLE

61010-2-040  IEC:2005 – 13 –
3.2.103
STERILIZER
equipment designed to achieve sterilization and which can also be used to deliver a sub-lethal
process for the treatment of materials
3.2.104
PRESSURE VESSEL
assembly comprising the jacket (if fitted), doors, and all other components in permanent
open connection with the CHAMBER
NOTE 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
the complete set of stages of the process that is carried out, in a specified sequence
NOTE Loading and unloading are not part of the OPERATING CYCLE.
3.5.2
HAZARD
Add the following new note:
NOTE In the context of this standard, 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.
4 Tests
This clause of Part 1 is applicable except as follows:
Additions:
4.3.2.3 Covers and removable parts
Add the following new second paragraph:
Covers 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.
4.3.2.11 Duty cycle
Add the following new second paragraph:
Equipment which can be operated continuously shall also be tested without any interval
between consecutive OPERATING CYCLES.
Add the following new subclause
4.3.2.101 Non-electrical supplies and systems
These shall be set to the least favourable RATED values.

61010-2-040  IEC:2005 – 15 –
4.4.2.4 Motors
Add the following new second paragraph:
If it is impracticable to test a motor in place, a separate identical motor shall be tested.
4.4.2.10 Heating devices
Add the following new item:
aa) loss of feed-water shall be simulated.
4.4.2.12 Interlocks
Add the following new third paragraph:
If an interlock provides protection against accidental contact with a toxic substance, it is
tested using a non-toxic substance.
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 system continuously.
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 minute 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, 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:
Add the following new subclause:
5.1.101 Overpressure safety device
The device (see 11.7.4) shall be marked with the name of the manufacturer, 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.

61010-2-040  IEC:2005 – 17 –
5.2 Warning markings
Replace the fifth paragraph by the following new paragraph:
Warning markings are specified in 5.1.5.1 c), 5.4.3 r), 6.1.2 b), 6.5.1.2 g), 6.6.2, 7.2 c), 7.3,
7.102 b), 7.102c), 10.1, the third paragraph (the first new additional paragraph) of Clause 9,
13.2.2, and 14.103.
5.4.1 General
Add the following two new items to the first paragraph, after item g):
aa) if a PRESSURE VESSEL is an integral part of the equipment, a declaration that it complies
with the PRESSURE VESSEL regulations and codes applicable in the country of intended
use, as specified in 14.101;
bb) if NORMAL USE involves the handling of hazardous substances, documentation shall
include necessary information on its constituents.
5.4.2 Equipment ratings
Add the following new item to the first paragraph, after item e):
aa) for each non-electrical supply, the RATED ranges of pressure and flow-rate.
5.4.3 Equipment installation
Replacement:
Replace the text of the subclause by the following:
Instructions shall include details of the following, if applicable:
a) location and mounting instructions, including the space required for safe and efficient
maintenance;
b) individual weights of principal heavy subassemblies;
c) overall weight and floor loading requirements;
d) assembly instructions;
e) MAINS supply requirements and connections, including the temperature RATING of any
cable required to meet 5.1.8;
f) for PERMANENTLY CONNECTED EQUIPMENT, requirements for any external switch or circuit-
breaker (see 6.11.2.1) and external overcurrent protection devices (see 9.5.1) and a
recommendation that the switch or circuit-breaker be near the equipment;
g) ventilation and drainage requirements (see 11.101, 13.1.103.1 and Note 2 to 13.1.101.4);
h) instructions for protective earthing;
i) sound power data and requirements (see 12.5.1);
j) requirements for special services, for example air, cooling liquid;
k) requirements related to hazardous gas atmospheres (see 13.0);
l) instructions to position the equipment so that it is not difficult to operate the disconnecting
device;
61010-2-040  IEC:2005 – 19 –
m) instructions relating to the handling and containment of hazardous substances, including
any need for additional equipment that may be required to control emissions (see 11.101,
13.1.101.3. and the note to 13.1.104);
n) a warning if a HAZARD could be caused by hot items falling from the equipment (see the
third paragraph (the first new paragraph) of Clause 9);
o) requirements for material used in the installation of the STERILIZER which may come in
contact with sterilant (see 13.1.103.4 and 13.2.101).
Conformity is checked by inspection.
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);
NOTE Such a ventilation system should normally give a minimum of 10 air changes per hour, but for large
installations this may need to be increased.
b) for equipment using toxic sterilant, means to protect against HAZARDS arising from failure
of the room ventilation system (see 13.1.103.3);
c) a non-recirculating local exhaust system to remove fugitive emissions (see 13.1.101.4);
d) a drainage system (see 13.1.101.3);
e) a venting system for the drain (see 13.1.101.3);
f) a CHAMBER exhaust system (see13.1.101.2);
g) a system used to control escaping biological emissions (see 13.1.104);
h) any other supply, for example sterilant, steam, compressed air, hot or cold water
(including instructions on the prevention of back syphonage – see 11.104).
Conformity is checked by inspection.
5.4.4 Equipment operation
Replace the text by the following new text:
Instructions for use shall include, if applicable:
a) identification of operating controls and their use in all operating modes;
b) an instruction not to position the equipment so that it is difficult to operate the
disconnecting device ;
c) instructions for interconnection to accessories and other equipment, including details of
suitable accessories, detachable parts and any special materials;
d) specification of limits for intermittent operation;
e) an explanation of symbols required by Part 1 and used on the equipment;
f) instructions for cleaning (see 11.2);
g) instructions for making the equipment safe after an incomplete OPERATING CYCLE ;
h) instructions for the correct use of the lockable door closure prevention device
(see 7.102.b))
61010-2-040  IEC:2005 – 21 –
i) instructions to the RESPONSIBLE BODY for safe access to the LOAD in the CHAMBER in the
event of a fault (see 13.1.102);
j) instructions for action in case of a malfunction, including fault diagnosis;
NOTE 1 These instructions may include any special methods of interpreting data recorded or noted during the
OPERATING CYCLE, to detect failure or trends that may lead to failure, for example the use of a temperature
recorder.
k) loading procedure;
l) instructions for safe disposal of parts such as detergent containers, sterilant containers
and parts contaminated by pathogenic material;
NOTE 2 Additional requirements on methods of disposal may be specified by national or local authorities.
m) instructions for testing the function of critical safety devices in a safe manner, for example
overpressure safety devices (see 11.7.4);
n) if NORMAL USE involves the handling of substances, instructions on correct use and safety
provisions. In addition, instructions shall be given on methods of safe handling before
disposal, and recommendations on disposal (also see Note 2 above);
o) details of methods of reducing burn HAZARDS from surfaces permitted to exceed the
temperature limits of Table 15;
p) guidelines to be followed in cases of emergency in which eye or skin contact or inhalation
could occur, such as release of toxic material or pathogenic material, or leakage from a
sterilizing agent container or disinfectant container or enzymatic, alkaline or acidic
detergent container;
NOTE 3 These guidelines should also be prominently displayed on or near the equipment
q) instructions for safely replenishing containers of dosing chemicals (see 13.102);
r) if a HAZARD could result from the use of equipment with a type of LOAD other than those for
which it is intended, there shall be an appropriate warning in the instructions, and a
warning marking (see 5.2) shall state the types of LOAD which may be used. If small
equipment has insufficient space for this warning marking, symbol 14 of Table 1 shall be
marked;
s) instructions for inspection, replenishment, and storage of consumable materials which
could cause a HAZARD, including details of HAZARDS which could arise from the introduction
of incorrect quantities of recommended consumable materials, also procedures and details
of the protection needed to minimise such HAZARDS.
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 4 The instructions should be in accordance with any national regulations about language which apply in the
country of intended use.
Conformity is checked by inspection.
5.4.5 Equipment maintenance
Replace the text by the following new text:
The manufacturer’s instructions shall specify the nature and frequency of inspections, tests,
and other preventative maintenance necessary to protect against HAZARDS. They shall include
details of parts likely to need replacement from time to time.

61010-2-040  IEC:2005 – 23 –
The manufacturer shall specify any parts which are required to be examined or supplied only
by the manufacturer or his agent.
NOTE 1 Except for the tests of Annex F, all the tests specified in this standard are TYPE TESTS designed to check
the safety of the design. The manufacturer should warn against the repetition of these tests as they could damage
the equipment. In particular, voltage tests, even those of Annex F, could cause progressive deterioration of
insulation.
Instructions shall include:
a) details of maintenance required on parts subject to wear if failure could lead to a HAZARD;
b) instructions for the inspection and replacement, if necessary, of any hoses or other parts
containing liquids, if their failure could cause a HAZARD;
c) details of safety devices fitted together with their settings and replacement procedures;
d) instructions for making the equipment safe prior to maintenance;
e) maintenance schedules and repair procedures, including any special precautions
necessary to protect against HAZARDS during repair;
f) instructions on methods of safe handling of any parts contaminated by pathogenic
material, detergent containers, etc., and recommendations on disposal procedure;
NOTE 2 Additional requirements on methods of disposal may be specified by national or local authorities.
g) for equipment using replaceable batteries, the specific battery types;
h) the ratings and characteristics of replaceable fuses.
Conformity is checked by inspection.
Add the following new subclauses:
5.4.101 OPERATOR training
5.4.101.1 General
In order that OPERATORs are adequately trained in the safe use of the equipment the
manufacturer's instructions shall state that the RESPONSIBLE BODY should ensure:
a) that all personnel who operate or maintain the equipment are trained in its operation and
in its safe use;
b) that, if STEL or LTEL limits (see note to 13.1) could be exceeded during NORMAL USE,
personnel working with toxic chemicals, gases, and vapours are given comprehensive
instruction in the process. This instruction includes information on relevant health
HAZARDS, national regulations, methods for safe use, and methods to detect escape of the
agent;
c) that there is regular training of all personnel concerned with the operation and
maintenance of the equipment, including emergency procedures for any toxic, flammable,
explosive or pathogenic material released into the environment. Records of attendance at
training are maintained, and evidence of understanding demonstrated.
Also see 7.2 b).
Conformity is checked by inspection.

61010-2-040  IEC:2005 – 25 –
5.4.101.2 Procedures for potentially hazardous actions
The manufacturer shall specify safety procedures for any potentially hazardous actions
intended to be carried out by an OPERATOR, for example the replacement of parts or the
adjustment of internal controls. The instructions shall specify that the RESPONSIBLE BODY must
provide OPERATORs with training in these procedures.
Conformity is checked by inspection.
6 Protection against electric shock
This clause of Part 1 is applicable except as follows:
6.1.1 Requirements
Add the following new second paragraph:
Also see 13.0 concerning electrical requirements in cases where a hazardous gas atmosphere
can be created by a potentially flammable or explosive sterilant.
6.2.1 Examination
Add the following new second paragraph:
FIXED EQUIPMENT, and equipment with a weight exceeding 80 kg, shall not be tilted or moved
in order to check the bottom, but the test finger is inserted into any gaps between the floor
and the bottom of the equipment.
6.9.1 General
Add the following new note after the second paragraph:
NOTE Although ceramics can provide satisfactory electrical insulation at ambient temperature, their insulating
properties are reduced at high temperatures. This is not only because they are susceptible to progressive
mechanical deterioration, but also because they can become electrically conductive at high temperatures and in
NORMAL USE can be contaminated by conductive material.
6.10.2 Fitting of non-detachable MAINS supply cords
Add the following new item
aa) the means for cord anchorage shall not be used to attach any other components.
Add the following new subclause:
6.101 Failure, or partial failure, of the MAINS supply
Failure or partial failure of the MAINS supply shall not cause any electrical or non-electrical
safety system to be disabled if a HAZARD could result.
Conformity is checked as specified in 4.4.2.102 to confirm that no HAZARD arises.

61010-2-040  IEC:2005 – 27 –
7 Protection against mechanical HAZARDS
Replace the title by the following new title
7 Protection against mechanical HAZARDS and against HAZARDS related to
mechanical functions
This clause of Part 1 is applicable except as follows:
7.1 General
Replace the second paragraph by the following new paragraph:
Conformity is checked as specified in 7.2 to 7.107.
Add the following new subclause:
7.1.101 Emergency shut-down device
If a HAZARD could arise from the function of the equipment, or be caused by an OPERATOR
error or a single fault, there shall be an easily reached and prominently placed push-button or
other actuator at one or more appropriate locations to operate an emergency shutdown
device. The shutdown device need not disconnect auxiliary circuits (such as cooling) which
are necessary to protect against HAZARD.
If a mechanical HAZARD could occur, there shall be an actuator within 1 m of the hazardous
moving part.
If the power supply to any door or conveyor is interrupted during operation, the shutdown
device shall operate automatically if a HAZARD could arise.
While an emergency shutdown device is in operation:
a) residual movement of any powered part such as a door or conveyor shall not create a
HAZARD;
b) potentially hazardous parts of the equipment shall return to a state in which a HAZARD
cannot occur. In addition to mechanical devices, such parts include valves, seals and
other components which are used to control compressed air, steam, liquids and
contaminated materials.
Unless an interlock system prevents restoration of normal operation until the hazardous
conditions are eliminated, a key, code or other equivalent means shall be required to reset the
shut-down device.
NOTE In some cases, the MAINS switch may meet the requirements of a shutdown device.
Conformity is checked by failure analysis, by inspection, and by:
1) operating and resetting each shut-down actuator in turn;
2) interrupting the power supply to each door or conveyor in turn during an OPERATING CYCLE,
then restoring the supply, to confirm that no HAZARD arises.

61010-2-040  IEC:2005 – 29 –
7.2 Moving parts
Deletion:
Delete the second paragraph.
7.3 Stability
Add the following new item:
aa) For equipment with a door which when open is horizontal or nearly horizontal, and
which could be used to support the LOAD, a weight equal to 1,2 times the heaviest RATED
LOAD is applied to, or suspended from, the centre of an open door.
7.4 Provisions for lifting and carrying
Replace the first paragraph by the following new text:
If carrying handles or grips are fitted to, or supplied with, the equipment, for example for
loading baskets, they shall be capable of withstanding a force of four times the mass they are
intended to support.
Replace the conformity paragraphs by the following new text:
Conformity is checked by inspection and the following test:
A single handle or grip is subjected to a force corresponding to four times the mass it is to
support. The force is applied uniformly over a 70 mm width at the centre of the handle or grip
without clamping. The force is steadily increased so that the test value is attained after 10 s
and maintained for a period of 1 min. If more than one handle or grip is fitted, the force is
distributed between the handles or grips in the same proportion as in NORMAL USE. If the
equipment is fitted with more than one handle or grip, but is so designed that it may readily
be carried by only one handle or grip, each handle or grip shall be capable of sustaining the
total force.
The handles or grips shall not break loose from the equipment and there shall not be any
permanent distortion, cracking or other evidence of failure.
Handles or grips supplied separately shall be tested after fitting in accordance with the
manufacturer’s instructions.
Add the following new subclause:
7.4.101 Transfer of LOADS into and out of the CHAMBER
Means shall be provided to protect the OPERATOR against mechanical HAZARDS that could arise
during transfer of the LOAD into or out of the CHAMBER.
Means shall be provided to locate and retain the LOAD and its carrier (if any) in the correct
position for transfer of the LOAD into or out of the CHAMBER.
If a sliding shelf within the CHAMBER has to be pulled out to accept the LOAD or permit its
withdrawal, means shall be provided to prevent the shelf tilting or becoming unintentionally
disengaged when pulled out.
61010-2-040  IEC:2005 – 31 –
The force required by an OPERATOR to put the LOAD into the CHAMBER or remove it from the
CHAMBER shall not exceed 250 N.
Conformity is checked by inspection and test, using the least favourable LOAD specified by the
the manufacturer.
Add the following seven new subclauses:
7.101 Doors, conveyors, etc.
A HAZARD shall not be caused in NORMAL CONDITION or SINGLE FAULT CONDITION by:
a) a mechanism used to open, close, or retain a door;
b) wear on threaded parts;
NOTE Threads meeting the requirements of ISO 2901, ISO 2902, ISO 2903 and ISO 2904 may be suitable.
c) residual movement caused by any of the following:
i) operation of an emergency shut-down device (see 7.1.101);
ii) loss of power;
iii) component failure;
iv) removal of an obstruction;
d) a part which is powered or driven from stored energy.
Conformity with a) and b) is c
...