SIST IEC 61010-3-043:2002

SLOVENSKI STANDARD
01-maj-2002
Safety requirements for electrical equipment for measurement, control and
laboratory use - Part 3-043: Conformity verification report for IEC 61010-2-043:1997
- Particular requirements for dry heat sterilizers using either hot air or hot inert gas
for treatment of medical materials and for laboratory processes
Safety requirements for electrical equipment for measurement, control and laboratory
use - Part 3-043: Conformity verification report for IEC 61010-2-043:1997 - Particular
requirements for dry heat sterilizers using either hot air or hot inert gas for treatment of
medical materials and for laboratory processes
Ta slovenski standard je istoveten z: IEC/TR 61010-3-043
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
19.080 (OHNWULþQRLQHOHNWURQVNR Electrical and electronic
SUHVNXãDQMH testing
71.040.10 Kemijski laboratoriji. Chemical laboratories.
Laboratorijska oprema Laboratory equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

TECHNICAL IEC
REPORT
TR 61010-3-043
First edition
2001-07
Safety requirements for electrical equipment
for measurement, control, and laboratory use –
Part 3-043:
Conformity verification report for
IEC 61010-2-043:1997 –
Particular requirements for dry heat sterilizers
using either hot air or hot inert gas for treatment
of medical materials and for
laboratory processes
Règles de sécurité pour appareils électriques de mesurage,
de régulation et de laboratoire –
Partie 3-043:
Rapport de vérificatoin de la conformité de
la CEI 61010-2-043:1997 –
Prescriptions particulières pour les stérilisateurs à chaleur
utilisant de l'air chaud ou un gaz inerte chaud pour
le traitement des matériels à usage médical et durant
les procédés de traitement de laboratoire
 IEC 2001  Copyright - all rights reserved
No part of this publication may be reproduced or utilized in any form or by any means, electronic or
mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: +41 22 919 0300 e-mail: inmail@iec.ch IEC web site http://www.iec.ch
Commission Electrotechnique Internationale
PRICE CODE
XA
International Electrotechnical Commission
For price, see current catalogue

– 2 – TR 61010-3-043  IEC:2001(E)
CONTENTS
FOREWORD . 3
Conformity verification report IEC 61010-2-043. 5
5 Marking and documentation .10
6 Protection against electric shock .14
7 Protection against mechanical hazards.21
8 Mechanical resistance to shock and impact .23
9 Equipment temperature limits and protection against the spread of fire .23
10 Resistance to heat .24
11 Protection against hazards from fluids .25
12 Protection against radiation, including laser sources, and against sonic
and ultrasonic pressure.26
13 Protection against liberated gases, explosion and implosion .26
14 Components .27
15 Protection by interlocks .29
16 Measuring circuits .29
Annex K…………. .30
Table 1 – Documents attached to this report . 7
Table 2 – Test equipment list. 8
Table 3 – List of components relied on for safety . 9
Form A.1 to Form A.29 .30 to 59

TR 61010-3-043  IEC:2001(E) – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT
FOR MEASUREMENT, CONTROL, AND LABORATORY USE –
Part 3-043: Conformity verification report for IEC 61010-2-043:1997–
Particular requirements for dry heat sterilizers using either hot air
or hot inert gas for treatment of medical materials
and for laboratory processes
FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of the 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, the IEC publishes International Standards. 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. The 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 the 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 National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical specifications, technical reports or guides and they are accepted by the National
Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
The main task of IEC technical committees is to prepare International Standards. However, a
technical committee may propose the publication of a technical report when it has collected
data of a different kind from that which is normally published as an International Standard, for
example “state of the art”.
Technical reports do not necessarily have to be reviewed until the data they provide are
considered to be no longer valid or useful.
IEC 61010-3-043, which is a technical report, has been prepared by IEC technical com-
mittee 66: Safety of measuring, control, and laboratory equipment.
The text of this technical report is based on the following documents:
Committee draft Report on voting
66/223/CDV 66/230/RVC
Full information on the voting for the approval of this technical report can be found in the report
on voting indicated in the above table.

– 4 – TR 61010-3-043  IEC:2001(E)
This publication has been drafted in accordance with the ISO/IEC Directives, Part 3.
This report is a Technical Report and is of a purely informative nature and is therefore by itself
not to be regarded as an International Standard. It is for use by test houses and other users to
assist them with determining and recording verification of conformity of the equipment under
test with the requirements of:
IEC 61010-2-043: 1997
and
IEC 61010-1:1990 + amendment 1:1992 + amendment 2:1995
The protocol for completion of this report is contained in publication IEC 61010-3:1997.
The IEC sells read-only PDF files as a general rule. In the present instance, and quite
exceptionally, to enable the user to fill in the forms, a revisable file is included in a pocket
affixed to the back cover of this publication.
This file can also be downloaded from the Web as a PDF file. There is, however, at the end of
the document, a revisable file containing the forms. Please use the zip/unzip function.
A bilingual version will not be issued.
A French version may be issued.
The committee has decided that the contents of this publication will remain unchanged
until 2004. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
TR 61010-3-043  IEC:2001(E) – 5 –
Conformity Verification Report
IEC 61010-2-043
Safety requirements for electrical equipment for measurement, control, and laboratory use –
Part 2-043: Particular requirements for dry heat sterilizers
using either hot air or hot inert gas for treatment of
medical materials, and for laboratory processes
Report reference No.:
Compiled by (+ signature).:
Approved by (+ signature).:
Date of issue.:
Testing organization.:
Address.:
Testing location .:
Applicant.:
Address.:
Standard.: IEC 61010-2-043:1997
and
IEC 61010-1:1990 + amendment 1:1992 + amendment 2:1995
Copyright blank test report.: This report has been prepared by IEC/TC 66, which retains
responsibility for any changes or corrections required.
Test procedure.:
Procedure deviation.:
Non-standard test method.:
Type of item tested.:     Laboratory
Trademark. .:
Model/type reference.:
Manufacturer.:
Rating.:
Copy of rating plate:
– 6 – TR 61010-3-043  IEC:2001(E)
Description of equipment function.:
INSTALLATION/OVERVOLTAGE CATEGORY:
OLLUTION DEGREE
P :
Environmental rating:  Standard  Other (specify):
Equipment mobility: Portable Hand-held  Floorstanding  Fixed
 Built in Benchmounted Other (specify):
Connection to mains supply:  Permanent Detachable   Non-detachable  None
Operating conditions: Continuous Short-time  Intermittent
Overall size of the equipment (Length x Width x Height):
Mass of the equipment (kg):
Marked degree of protection to IEC 60529:  IP___  ___
Accessories and detachable parts included in the evaluation:
Options:
NOTE  "(see form A.X)" refers to a form appended to the report.

TR 61010-3-043  IEC:2001(E) – 7 –
Table 1 – Documents attached to this report
Document No Document description Number of pages

– 8 – TR 61010-3-043  IEC:2001(E)
Table 2 – Test equipment list
Item Type Equipment Calibration date Comments
1)
No. Last Due
1)
or interval between calibrations.

TR 61010-3-043  IEC:2001(E)             – 9 –
Table 3 – List of components relied on for safety
Unique component Application/Function Manufacturer and part number RATING Licence number,
reference or location file number or other
(note 1) (note 2)
(including drawing documentary evidence
reference if required) of acceptance
NOTE 1  List all manufacturers concerned.
NOTE 2  Electrical, mechanical, flammability, etc.

– 10 – TR 61010-3-043  IEC:2001(E)
Clause Requirement Result Comments
Subclause
5 Marking and documentation
5.1.1 General
Required equipment markings are:
a) visible:
– from the exterior
or
– after removing a cover
or
– opening a door
or
– after removal from a rack or panel
b) not put on parts which can be removed
by an OPERATOR
c) Letter symbols (IEC 60027) used
d) Graphic symbols
(IEC 61010-1, Table 1) used
5.1.2 Identification
Equipment is identified by:
– manufacturer's name or registered
trade mark
– model number, name or other means
5.1.3 Mains supply
Equipment is marked as follows:
a) nature of supply:
–a.c. RATED mains frequency or range of
frequencies
– d.c. with symbol 1
b) RATED supply voltage(s) or range
c) – maximum RATED power (W or VA)
or input current
If more than one voltage range:
– separate values marked
or
– values differ by less than
20 % (see Form A.3)
F
d) OPERATOR – set for different RATED
supply voltages:
– indicates the equipment set voltage
– PORTABLE EQUIPMENT indication is
visible from the exterior
– changing the setting changes the
indication
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-043  IEC:2001(E) – 11 –
Clause Requirement Result Comments
Subclause
e) Accessory mains socket-outlets
accepting standard mains plugs are
marked:
– with the voltage, if it is different from
the mains supply voltage
– for use only with specific equipment
If not marked for specific equipment, it is
marked with:
– the maximum RATED current or power,
and maximum permitted leakage current
or
– symbol 14 with full details in the
documentation
F The measured value not more than
110 % (see Form A.3)
5.1.4 Fuses
OPERATOR replaceable fuse marking (see
also 5.4.5)
5.1.5 Measuring circuit TERMINALS Not applicable
5.1.6 TERMINALS and operating devices
Where necessary for safety, indication of
purpose of TERMINALS, connectors, controls
and indicators
Mains supply TERMINALS identified
Power supply switch on or off position
marked if used as disconnecting device
TERMINAL marking:
a) FUNCTIONAL EARTH TERMINALS
b) PROTECTIVE CONDUCTOR TERMINALS:
– symbol 6 is placed close to or on the
TERMINAL
or
– part of appliance inlet
c) TERMINALS of measuring and control
circuits
d) TERMINALS supplied from the interior
e) ACCESSIBLE FUNCTIONAL EARTH
TERMINALS
NORMAL USE
aa) setting a control could
cause a hazard, an indicating device is
provided
5.1.7 Equipment protected by DOUBLE
INSULATION or REINFORCED INSULATION
Protected throughout (symbol 11 used)
Only partially protected (symbol 11 not
used)
Result: P = Pass  F = Fail  NA = Not Applicable

– 12 – TR 61010-3-043  IEC:2001(E)
Clause Requirement Result Comments
Subclause
5.1.8 Battery charging
Equipment with means to charge re-
chargeable batteries is marked:
– to warn against the charging of non-
rechargeable batteries
– to indicate the type of rechargeable
battery used
5.2 Warning markings
– visible when ready for NORMAL USE
– if necessary, marked with symbol 14
– are near or on applicable parts
– statement to isolate or disconnect
– advice how to avoid contact with
ACCESSIBLE HAZARDOUS LIVE
parts
– easily touched high temperature parts
(symbol 13)
– if lockable door, to lock and retain key
– load type
5.2.101 Equipment with high ACCESSIBLE current
If equipment must be permanently
connected to protect against high
ACCESSIBLE current, a warning marking is
provided
5.2.102 Hot items falling out of equipment
If hot items can fall onto the equipment
support surface, a warning marking is
provided
5.3 Durability of markings
The required markings remain clear and
F legible in NORMAL USE (see Form A.4)
5.4 Documentation
5.4.1 General
Equipment is accompanied by
documentation which includes:
– technical specification
– instructions for use
– name and address of manufacturer or
supplier
Definition of INSTALLATION CATEGORY
Warning statements and a clear
explanation of warning symbols:
– provided in the documentation
or
– information is marked on the equipment
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-043  IEC:2001(E) – 13 –
Clause Requirement Result Comments
Subclause
– instructions on warning signs for
country of use
5.4.2 Equipment RATINGS
Documentation includes:
– supply voltage or voltage range
– frequency or frequency range
RATING
– power or current
– a description of all input and output
connections
– RATING of insulation of external circuits,
when such circuits are nowhere ACCESSIBLE
– statement of the range of
environmental conditions
5.4.3 Equipment Installation
Instructions include:
– location and mounting instructions
including space for maintenance
– individual weights of principle heavy
subassemblies
– assembly instructions
– main supply requirements and
connections
– ventilation
– protective earthing
– sound power data requirements
– requirements for special services
5.4.3.101 Drying-out
After transport or storage in humid
conditions, equipment could fail to meet
the requirements in the standard;
instructions shall include a warning
5.4.4 Equipment operation
Instructions include:
a) operating controls:
i) interconnection
ii) use
b) positioned so that disconnection is
difficult
c) accessories:
i) interconnection
ii) suitability
iii) detachable parts and special materials
Result: P = Pass  F = Fail  NA = Not Applicable

– 14 – TR 61010-3-043  IEC:2001(E)
Clause Requirement Result Comments
Subclause
d) limits for intermittent operation
e) explanation of symbols used
f) cleaning
g) lockable door closure stop:
– correct use
– retain key
h) safe use of override key
i) action in case of malfunction
5.4.5 Equipment maintenance
Instructions include:
i) maintenance on threaded parts
ii) safety devices fitted
– replacement of hoses, etc.
– specific battery type
– any manufacturer specified parts
– RATING and characteristics of fuses
6 Protection against electric shock
F (see Form A.5)
6.1 General
Conformity is checked by the determination
of 6.2 and 6.3 followed by the tests of 6.4
to 6.12
Abestos is not used
6.1.1 Exceptions
F Capacitance test (see Forms A.6
and A.7)
6.2 Determination of ACCESSIBLE parts
F (see Form A.6)
6.3 Permissible limits for ACCESSIBLE parts
6.3.1 Values in NORMAL CONDITION
(see Form A.7)
F
6.3.1.2 Levels of PERMANENTLY CONNECTED
equipment are 1.5 times the values (see
Form A.7)
6.3.2 Values in SINGLE FAULT CONDITION
(see Form A.8)
F
6.3.2.2 Levels of PERMANENTLY CONNECTED
equipment are 1,5 times the values (see
Form A.8)
6.4 Protection in NORMAL CONDITION
(see 6.8 and 8.1)
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-043  IEC:2001(E) – 15 –
Clause Requirement Result Comments
Subclause
6.5 Protection in SINGLE FAULT CONDITION
Additional protection is provided by:
– one or more of 6.5.1 to 6.5.3
or
– automatic disconnection of the supply
6.5.1 Protective earthing
ACCESSIBLE conductive parts:
– bonded to the protective conductor
terminal
or
– separated by screen or BARRIER from
parts which are HAZARDOUS LIVE
(For indirect bonding of measurement and
test equipment, see 6.5.1.4)
6.5.1.1 PROTECTIVE BONDING
PROTECTIVE BONDING consists of directly
connected structural parts or discrete
conductors or both; and withstands thermal
and dynamic stresses
6.5.1.2 Bonding impedance of plug-connected
F equipment (see Form A.9)
6.5.1.3 Bonding impedance of PERMANENTLY
F CONNECTED EQUIPMENT (see Form A.9)
6.5.1.4 Indirect bonding for measuring and test
F equipment (see Form A.9)
6.5.2 DOUBLE INSULATION and REINFORCED
INSULATION
(see 6.7, 6.8 and 6.9.2)
6.5.3 PROTECTIVE IMPEDANCE
F (see Form A.10)
Components wires and connections are
RATED as required
6.5.4 Built-in panel meters
If, after building-in, the requirements of
6.5.1 to 6.5.3 are not met, the panel meter:
– has no ACCESSIBLE conductive parts
– has basic insulation of accessible
surfaces
– has DOUBLE/REINFORCED INSULATION of
ACCESSIBLE
surface of parts intended to be
grasped
6.6 External circuits
6.6.1 Separation of internal circuits
F (see list in Forms A.1 and A.5)
If the other internal circuit exceeds the
values of 6.3.2 in NORMAL CONDITION and
only BASIC INSULATION:
Result: P = Pass  F = Fail  NA = Not Applicable

– 16 – TR 61010-3-043  IEC:2001(E)
Clause Requirement Result Comments
Subclause
a) short-circuit could not make external
circuit HAZARDOUS LIVE
b) manufacturer's instructions include:
– a statement that the TERMINAL for
external circuits is for use only with
equipment which has no live parts which
are ACCESSIBLE
– the RATING of the insulation required for
external circuits
– the connection to be used at the remote
end of external circuits
– the type of equipment which may be
connected to the TERMINAL
6.6.2 TERMINALS for external circuits
ACCESSIBLE TERMINALS are not HAZARDOUS
LIVE, except as permitted by 6.1.1
The following terminals are not hazardous
live:
– PROTECTIVE CONDUCTOR TERMINALS
– FUNCTIONAL EARTH TERMINALS
– headphone TERMINALS
TERMINALS which receive a charge from an
F internal capacitor (see Form A.7)
High-voltage TERMINALS energized from the
interior are:
– not accessible
or
–marked
6.6.3 Circuits with TERMINALS which are
HAZARDOUS LIVE
These circuits:
ACCESSIBLE
– are not connected to
conductive parts
or
– are connected to ACCESSIBLE
conductive parts, but are not mains circuits
and have one TERMINAL contact at earth
potential
No ACCESSIBLE conductive parts are
HAZARDOUS LIVE
6.7 CLEARANCES and CREEPAGE DISTANCES
(see annex D of IEC 61010-1 and
F Form A.11)
6.8 Dielectric strength tests
(see annex E of IEC 61010-1 and
F Form A.12)
Protection against the spread of fire
(see 9.1)
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-043  IEC:2001(E) – 17 –
Clause Requirement Result Comments
Subclause
6.9 Constructional requirements for
protection against electric shock
6.9.1 General
In circuits exceeding the values of 6.3.2:
– security of wiring connections
– screws securing removable covers
– accidental loosening
6.9.2 ENCLOSURES of equipment with DOUBLE
INSULATION or REINFORCED INSULATION
NCLOSURE
E surrounds all metal parts
except for small metal parts which are
separated
NCLOSURES
E or parts made of insulating
material
Protection for metal ENCLOSURES or parts
by:
– protective impedance
or
– an insulating coating or BARRIER on the
inside
or
– CLEARANCES and CREEPAGE DISTANCES
cannot be reduced by loosening of parts or
wires
6.9.3 Equipment using PROTECTIVE BONDING
a) OPERATOR removable parts
b) Movable conductive connections
c) Exterior metal braids of cables
d) Mains passed through the equipment
e) Protective earthing conductors
green/yellow
Exceptions:
– earthing braids
– internal protective conductors
f) Equipment using PROTECTIVE BONDING
6.9.4 Over-range indication
6.10 Connection to mains supply source and
connections between parts of equipment
6.10.1 Mains supply cords
RATED for maximum equipment current
(see 5.1.3c)
Cable complies with IEC 60227 or
IEC 60245 or is a certified cord
Heat resistant if likely to contact hot parts
Result: P = Pass  F = Fail  NA = Not Applicable

– 18 – TR 61010-3-043  IEC:2001(E)
Clause Requirement Result Comments
Subclause
RATING
Temperature (cord and inlet)
Green/yellow used only for connection to
PROTECTIVE CONDUCTOR TERMINALS
Detachable cords with IEC 60320 mains
connectors:
– comply with IEC 60799
or
– have the current RATING of the mains
connector
6.10.2 Fitting of non-detachable mains supply
cords
6.10.2.1 Cord entry
Non-detachable cord protection:
– inlet smoothly rounded with radius
≥1,5 D
or
– insulated cord guard protruding ≥5 D
6.10.2.2 Cord anchorage
The protective earth conductor is the last
to take the strain
Cord anchorages:
– the cord is not clamped by direct
pressure from a screw
– knots are not used
– cannot push the cord into the
equipment to cause a hazard
– no failure of cord insulation in
anchorage with metal parts
– compression bushing:
a) clamps all types and sizes of mains
cords
and
b) is suitable:
i) for connection to TERMINALS provided
or
ii) it is designed for screened mains cord
– cord replacement does not cause a
hazard and method of strain relief is clear
F Push-pull test (see Form A.13)
– not used to attach any other component
6.10.3 Plugs and connectors
a) Mains supply plugs, connectors etc.,
conform with relevant specifications
b) If equipment supplied at voltages below
6.3.2.1:
– plugs of mains supply cords do not fit
mains sockets above RATED supply voltage
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-043  IEC:2001(E) – 19 –
Clause Requirement Result Comments
Subclause
– mains type plugs used only for
connection to mains supply
c) Plug pins which receive a charge from
F an internal capacitor (see Form A.7)
d) Accessory mains socket outlets:
– if a standard mains plug is accepted,
there is a marking (see 5.1.3e)
– input has a protective earth conductor if
TERMINAL
outlet has earth contact
6.10.101 Connection of non-detachable mains
cords to TERMINALS
Flexible cables or cords attached to
TERMINAL blocks:
– no special preparation of conductor
required
– designed and positioned so that
conductor does not slip out
6.11 TERMINALS
6.11.1 ACCESSIBLE TERMINALS
a) No risk of accidental contact
(see also 5.1.6c)
b) Will not work loose
6.11.2 PROTECTIVE CONDUCTOR TERMINAL
a) Appliance inlet (no requirement)
b) For rewirable cords and PERMANENTLY
CONNECTED EQUIPMENT, PROTECTIVE
CONDUCTOR TERMINAL is close to mains
TERMINALS
supply
c) If no mains supply is required, any
PROTECTIVE CONDUCTOR TERMINAL:
– is near TERMINALS of circuit for which
protective earthing is necessary
– external if other TERMINALS external
d) Equivalent current-carrying capacity to
mains supply TERMINALS
e) Soldered connections:
i) independently secured
ii) not used for other purposes
– Screw connections are secured
f) Contact surfaces are metal
g) If plug-in, makes first and breaks last
h) Protective conductor of measuring
circuit:
– current RATING
Result: P = Pass  F = Fail  NA = Not Applicable

– 20 – TR 61010-3-043  IEC:2001(E)
Clause Requirement Result Comments
Subclause
– protective bonding:
i) not interrupted
or
ii) indirect bonding
6.11.3 FUNCTIONAL EARTH TERMINALS
Independent connection
6.12 Disconnection from supply source
6.12.1 General
Disconnection device provided
6.12.1.1 Exception to 6.12.1
Short-circuit or overload cannot cause a
hazard
6.12.2 Requirements according to type of
equipment
6.12.2.1 PERMANENTLY CONNECTED EQUIPMENT
– switch or circuit breaker is part of the
equipment
or
– documentation specifies switch location
and marking
6.12.2.2 Single-phase cord-connected equipment
– switch or circuit breakers
or
– appliance coupler (disconnectable
without TOOL)
or
– separable plug (without locking device)
6.12.2.3 Hazards arising from function
Emergency switch
Emergency switch <1 m from the moving
part
6.12.3 Disconnecting devices
Electrically close to the supply
6.12.3.1 Switches and circuit-breakers
When used as disconnection device:
– meet IEC 60947-1 and IEC 60947-3
– contact separation
– contact position evident in off position
– marked to indication function
– not incorporated in mains cord
– does not interrupt protection earth
conductor
– if has other contacts, meets separation
requirements of 6.6 and 6.7
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-043  IEC:2001(E) – 21 –
Clause Requirement Result Comments
Subclause
6.12.3.2 Appliance couplers and plugs
Where an appliance coupler or separable
plug is used as the disconnecting device
(see 6.12.2.2):
– readily identifiable and easily reached
by the OPERATOR
– single phase PORTABLE EQUIPMENT cord
length ≤3 m
Protective earth conductor connected first
and disconnected last
6.12.101 Disconnection by interruption of the
mains supply
Interruption of the supply does not cause a
hazard
7 Protection against mechanical hazards
7.1 General
Conformity is checked by 7.2 to 7.5
7.1.101 Door closure and retaining mechanism
Failure mode analysis of the door closure
mechanism (see Table 1)
7.2 Moving parts
Moving parts not able to crush, etc. (see
also 6.12.2.3)
OPERATOR
If access permitted:
a) access requires TOOL
b) statement about training
c) warning markings or symbol 14
7.2.101 Powered doors
7.2.101.1 Shut-down device
Each door shut-down device:
– easily accessible
– prominently placed
– not self resetting
When operating:
a) residual movement not a hazard
b) other safety components return to a
safe condition
c) resetting through key, code or
equivalent
7.2.101.2 Door motion reversal and stoppage
Closing
– force <150 N
Result: P = Pass  F = Fail  NA = Not Applicable

– 22 – TR 61010-3-043  IEC:2001(E)
Clause Requirement Result Comments
Subclause
or
– reverses before 150 N
Opening hinged door <150 N
7.2.101.3 Sliding doors
Power interrupt:
–<1 cm/s
– <10 cm
Parts disconnected:
– ≤1 cm/s
– ≤10 cm
7.2.101.4 Interruption of the mains supply
No mechanical hazard
7.3 Stability
Marking of non-automatic means
Conformity tests:
– 10° tilt test
– multi-directional force test
– downward force test
7.4 Provisions for lifting and carrying
Handles or grips withstand four times mass
Equipment >18 kg:
– has means for lifting or carrying
or
– directions in documentation
7.4.101 Provision for transferring the LOAD into
and out of the CHAMBER
Means to protect OPERATOR against
mechanical hazard
Prevention of shelf tilting or disengagement
7.5 Expelled parts
Equipment contains or limits the energy
Protection not removable without the aid of
a TOOL
7.101 Door interlocks
7.101.1 General
Interlocks prevent:
a) hazardous access, 1 000 N applied
b)
i) no hot air or hot gas enters the
CHAMBER until door secured
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-043  IEC:2001(E) – 23 –
Clause Requirement Result Comments
Subclause
CHAMBER
ii) no heaters in the are
energized until door secured
c) means to prevent new OPERATING CYCLE
after interlock system failure
7.101.2 Door interlocks for double-ended
STERILIZER
OPERATOR cannot operate remote door
(except automatic loading)
7.102 Prevention of door closure
CHAMBER >0,7 m deep and 0,4 m in
which an OPERATOR can enter:
– lockable device prevents door closing
– instructions to retain locking means
8 Mechanical resistance to shock and
impact
After the tests of 8.1 to 8.4
F (see Form A.11):
F – voltage tests (see Form A.12)
– inspection, equipment meets the
following requirements:
HAZARDOUS LIVE ACCESSIBLE
a) parts not
b) ENCLOSURE shows no cracks (hazard)
c) CLEARANCES not less than their
F permitted values
(see Form A.11)
– BARRIERS not damaged or loosened
– no moving parts exposed, except as
permitted by 7.2
– no damage which could cause spread
of fire
9 Equipment temperature limits and
protection against the spread of fire
9.1 General
Conformity is checked by:
– 9.2 and fault tests of 4.4
(see Forms A.1, A.2 and A.18)
F
or
– measurement of CREEPAGE DISTANCE
and CLEARANCE and the voltage tests of
annex G
F (see Form A.14)
or
– method of annex F
F (see Forms A.15, A.16 and A.17)
– abestos is not used
9.2 Temperature tests
Result: P = Pass  F = Fail  NA = Not Applicable

– 24 – TR 61010-3-043  IEC:2001(E)
Clause Requirement Result Comments
Subclause
9.3 Guards
Surfaces liable to exceed 100 °C
F (see Form A.18):
– protected by guards
or
–marked
or
– intended to be hot (see 9.1)
Guards not removable without TOOL
9.4 Field-wiring TERMINAL boxes
Temperature RATING of the cable is:
F – marked (see Form A.18)
and
– adjacent to field-wiring TERMINALS
or
– visible during and after installation
9.5 Overtemperature protection devices
– fitted, to operate in SINGLE FAULT
CONDITION (see Form A.1)
F
– meets 14.3
– does not operate in NORMAL USE
(see 3.5.6)
– if self-resetting, can only be set to
operate in SINGLE FAULT CONDITION
Overtemperature protection:
– separate from temperature control
– not self-resetting
– resetting by solder not required
9.6 Overcurrent protection
9.6.1 PERMANENTLY CONNECTED EQUIPMENT
Device:
– fitted within the equipment
or
– specified in manufacturer's instructions
9.6.2 Other equipment
Protection within the equipment
Devices not in the protective conductor
Fuses or single pole circuit-breakers not
fitted in neutral (multi-phase)
10 Resistance to heat
10.1 Integrity of CLEARANCE and CREEPAGE
F DISTANCES (see Form A.11)
10.2 Resistance to heat of non-metallic
F ENCLOSURE (see Form A.19)
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-043  IEC:2001(E) – 25 –
Clause Requirement Result Comments
Subclause
10.3 Resistance to heat of insulation material
Parts supporting:
– parts connected to mains supply
– TERMINALS carrying >0,5 A
11 Protection against hazards from fluids
11.1 General
11.2  F Cleaning (see Form A.20)
11.3  F Spillage (see Form A.20)
11.4  F Overflow (see Form A.20)
11.5 Battery electrolyte
Battery electrolyte leakage presents no
hazard
11.6 Specially protected equipment
F (see Form A.20)
11.7 Fluid pressure and leakage
11.7.1 Maximum pressure
Maximum pressure not exceeded
11.7.2 Leakage and rupture at high pressure
F (see Form A.21)
Test to IEC 60335 (refrigeration only)
11.7.3 Leakage from low-pressure parts
F (see Form A.21)
11.7.4 Overpressure safety device
– shall not operate in NORMAL USE
and
– shall comply with the following:
– positioned close to parts intended to be
protected
– access for inspection, maintenance and
repair
– adjustment only with TOOL
– no discharge to person
– no hazard from discharge
– sufficient discharge capacity
– no shut-off valve between protective
device and protected parts
11.101 Interruption of supplies and services
No fluid hazard
Result: P = Pass  F = Fail  NA = Not Applicable

– 26 – TR 61010-3-043  IEC:2001(E)
Clause Requirement Result Comments
Subclause
12 Protection against radiation, including
laser sources, and against sonic and
ultrasonic pressure
12.1 General
12.2 Equipment producing ionizing radiation
12.2.1    F Ionizing radiation (see Form A.22)
12.2.2 Accelerated electrons
12.3 Ultra-violet radiation (Conformity test under consideration)
12.4 Micro-wave radiation (Conformity test and limit of 10 W/m are
under consideration)
12.5 Sonic and ultrasonic pressure
12.5.1    F Sound level (see Form A.23)
12.5.2    F Ultrasonic pressure (see Form A.23)
12.6 Laser sources (IEC 60825)
13 Protection against liberated gases,
explosion and implosion
13.1 Poisonous and injurious gases
Attach any data/test reports used to
demonstrate conformity
13.2 Explosion and implosion
13.2.1 Components
Components liable to explode:
– pressure release device
or
– the apparatus incorporates OPERATOR
protection (see also 7.5)
Pressure release device:
– discharge without danger
– not obstructable
13.2.2 Batteries
Explosion or fire hazard:
– protection incorporated in the
equipment
or
– instructions specify batteries
and
– single component cannot cause hazard
(short-circuit and open circuit)
(see Form A.24, including circuit diagram)
F
– warning marking or symbol 14
Battery compartment design
Polarity reversal test
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-043  IEC:2001(E) – 27 –
Clause Requirement Result Comments
Subclause
13.3 Implosion of high-vacuum devices
High vacuum devices:
– intrinsically protected and correctly
mounted
or
– ENCLOSURE provides protection:
i) screen not removable without TOOL
ii) if glass screen, not in contact
13.101 CHAMBER exhaust system
Discharge no hazard
13.102 LOAD access after a fault
Under single fault:
– no safety devices disabled
– no access to LOAD until no hazard
14 Components
14.1 General
Where safety is involved, components
meet relevant requirements (see Table 3 of
this report and Figure 5 of IEC 61010-1/A2)
14.2 Motors
14.2.1 Motor temperatures
F (see Form A.25)
Current drawn by a stopped fully energized
motor does not cause a hazard
Loss of one phase of a three phase motor
does not cause a hazard
14.2.2 Series excitation motors
14.3 Overtemperature protection devices
Devices operating in a SINGLE FAULT
F CONDITION (see Form A.26)
and have/are:
– reliable function
– RATED to interrupt maximum voltage
and current of circuit
– RATED for maximum surface
temperature of 4.4.4.2
– RATED for maximum temperature of 9.2
for parts in contact with flammable liquid
– not self-resetting unless protected part
cannot function
Result: P = Pass  F = Fail  NA = Not Applicable

– 28 – TR 61010-3-043  IEC:2001(E)
Clause Requirement Result Comments
Subclause
14.4 Fuse holders
No access to HAZARDOUS LIVE parts
14.5 Mains voltage selecting devices
Accidental change not possible
14.6 HIGH INTEGRITY components
Used in applicable positions
(see Table 3)
Conforms with IEC publications
Not a single electronic device
14.7 Mains transformers
14.7.1 Short-circuit tests
Transformers meet 4.4.4.1 to 4.4.4.3
F (see Form A.27)
14.7.2 Overload tests
Transformer:
– has overtemperature protection
meeting 14.3
or
– meets 4.4.4.1 to 4.4.4.3
F (see Form A.28)
14.8 Overpressure safety devices
Meets ISO 4126
14.101 Visibility and readability of instruments
and indicating devices
Devices related to safety located where
readily seen by OPERATOR
Except for cycle counters, readable at 1 m
with an external illumination of 215 lux +15
lux
14.102 Control system
OPERATOR cannot set to hazardous
condition
Automatic controller provided with system
to control access to system functions
No keys, codes or TOOLS for OPERATING
CYCLE
:
– initiation
– termination
Functions b), c) and d) protected by
increasingly severe restraints
Not possible to disable safety devices:
– using automatic controller
– using manual advance
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-043  IEC:2001(E) – 29 –
Clause Requirement Result Comments
Subclause
Manual mode disables automatic controller
14.103 Microprocessors
Failure cannot cause a hazard
14.104 Access ports
Access port retained by interlock under
7.101
or
Independent interlock provided
15 Protection by interlocks
15.1 General
Interlocks are designed to remove a hazard
before OPERATOR exposed
15.2 Prevention of reactivation
15.3 Reliability
16 Measuring circuits
16.1 Current measuring circuits
F (see Form A.29)
Annex K Routine tests
Manufacturer’s declaration
Result: P = Pass  F = Fail  NA = Not Applicable

– 30 – TR 61010-3-043  IEC:2001(E)
Summary of SINGLE FAULT CONDITIONS applied (4.4.2)                        Form A.1
(see Form A.2 for details of tests)
Does
Carried
Subclause Title not Comments
out
apply
4.4.2.1 PROTECTIVE IMPEDANCE
4.4.2.2 Protective conductor
4.4.2.3 Equipment or parts for short-term or
intermittent operation
4.4.2.4 Motors
4.4.2.5 Capacitors
4.4.2.6 Mains transformers
Attach drawing of mains Txs showing
all protective devices (see Forms
A.27 and A.28)
4.4.2.7 Outputs
4.4.2.8 Equipment for more than one supply
4.4.2.9 Cooling
– air holes closed
– fans stopped
– coolant stopped
4.4.2.10 Heating devices
– timer overridden
– temperature controller overridden
– loss of cooling liquid
4.4.2.11 Insulation between circuits and parts
4.4.2.12 Interlocks
List below all SINGLE FAULT CONDITIONS not covered
by 4.4.2.1 to 4.4.2.12
TR 61010-3-043  IEC:2001(E)       – 31 –
Form A.2
4.4  Testing in SINGLE FAULT CONDITION – Results
T Meets
d
How was test terminated
Test Fault
Fault description 4.4.3 4.4.4
subclause No.
Comments
(note 1)
1)  T = Test duration in h:min:s
d
Record dielectric strength test on Form A.12 and temperature tests on Form A.18.
Record in the comments column for each test whether carried out during or after SINGLE FAULT CONDITION.
Tested by: ____________________ Date: ________ Test equipment No. (Table 2) __________________

– 32 – TR 61010-3-043  IEC:2001(E)
Form A.3
5.1.3.c  Mains supply
Marked NOTE Measurements are only required for marked
RATINGS
RATING:________________________________________
_____________________Phase
_____________________Hz
_____________________A
_____________________W
_____________________VA
Test Voltage Freq. Current Power Power Comments
in in
No.
V Hz I W VA
General comments:
Tested by:_________________________Date:______________
Test equipment No. (Table 2)__________________

TR 61010-3-043  IEC:2001(E) – 33 –
Form A.4
5.3  Durability of markings
Table A.4.1 – Marking method (note) Table A.4.2 – Agent
A (specify agent)
B (specify agent)
C Water
D Isopropyl alcohol
NOTE Where applicable include print method,
label material, ink or paint type, fixing method,
adhesive and surface to which marking is fixed.
Marking location Marking method (see Table A.4.1)
Identi
...