IEC TR 61010-3-041:1999

TECHNICAL IEC
REPORT
TR 61010-3-041
First edition
1999-10
Safety requirements for electrical equipment
for measurement, control, and laboratory use –
Part 3-041:
Conformity verification report for
IEC 61010-2-041:1995, Particular requirements
for autoclaves using steam for the treatment of
medical materials, and for laboratory processes
Règles de sécurité pour appareils électriques de mesurage,
de régulation et de laboratoire –
Partie 3-041:
Rapport de vérification de la conformité de la
CEI 61010-2-041:1995, Prescriptions particulières pour
autoclaves utilisant de la vapeur pour le traitement des
matériels à usage médical et durant les procédés de
traitement de laboratoire
Reference number
IEC/TR 61010-3-041:1999(E)
Numbering
As from 1 January 1997 all IEC publications are issued with a designation in the
60000 series.
Consolidated publications
Consolidated versions of some IEC publications including amendments are

available. For example, edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the
base publication, the base publication incorporating amendment 1 and the base

publication incorporating amendments 1 and 2.

Validity of this publication
The technical content of IEC publications is kept under constant review by the IEC,
thus ensuring that the content reflects current technology.
Information relating to the date of the reconfirmation of the publication is available
in the IEC catalogue.
Information on the subjects under consideration and work in progress undertaken
by the technical committee which has prepared this publication, as well as the list
of publications issued, is to be found at the following IEC sources:
• IEC web site*
•
Catalogue of IEC publications
Published yearly with regular updates
(On-line catalogue)*
• IEC Bulletin
Available both at the IEC web site* and as a printed periodical
Terminology, graphical and letter symbols
For general terminology, readers are referred to IEC 60050: International
Electrotechnical Vocabulary (IEV).
For graphical symbols, and letter symbols and signs approved by the IEC for
general use, readers are referred to publications IEC 60027: Letter symbols to be
used in electrical technology, IEC 60417: Graphical symbols for use on equipment.
Index, survey and compilation of the single sheets and IEC 60617: Graphical symbols
for diagrams.
* See web site address on title page.

TECHNICAL IEC
REPORT
TR 61010-3-041
First edition
1999-10
Safety requirements for electrical equipment
for measurement, control, and laboratory use –
Part 3-041:
Conformity verification report for
IEC 61010-2-041:1995, Particular requirements
for autoclaves using steam for the treatment of
medical materials, and for laboratory processes
Règles de sécurité pour appareils électriques de mesurage,
de régulation et de laboratoire –
Partie 3-041:
Rapport de vérification de la conformité de la
CEI 61010-2-041:1995, Prescriptions particulières pour
autoclaves utilisant de la vapeur pour le traitement des
matériels à usage médical et durant les procédés de
traitement de laboratoire
 IEC 1999  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
XB
International Electrotechnical Commission
For price, see current catalogue

– 2 – TR 61010-3-041  IEC:1999(E)

CONTENTS
Page
FOREWORD . 3

Conformity verification report IEC 61010-3-041 . 5

Clause
5 Marking and documentation. 10

6 Protection against electric shock . 16

7 Protection against mechanical hazards. 23
8 Mechanical resistance to shock, vibration and impact . 26
Mechanical resistance to shock and impact (AM 2)
9 Equipment temperature limits and protection against the spread of fire . 27
10 Resistance to heat . 28
11 Resistance to moisture and liquids . 29
Protection against hazards from fluids (AM 2)
12 Protection against radiation, including laser sources, and against sonic and
ultrasonic pressure. 31
13 Protection against liberated gases, explosion and implosion . 31
14 Components. 32
15 Protection by interlocks . 35
16 Measuring circuits (AM 2). 35
Annex K (AM 2) . 35
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.30 .36 to 65

TR 61010-3-041  IEC:1999(E) – 3 –

INTERNATIONAL ELECTROTECHNICAL COMMISSION

__________
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT

FOR MEASUREMENT, CONTROL, AND LABORATORY USE –

Part 3-041: Conformity verification report for IEC 61010-2-041:1995,

Particular requirements for autoclaves using steam

for the 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 technical report 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 61010-3-041, which is a technical report, has been prepared by IEC technical
committee 66: Safety of measuring, control, and laboratory equipment.
The text of this technical report is based on the following documents:
Enquiry draft Report on voting
66/193/CDV 66/217/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 61010-3-041  IEC:1999(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 testhouses and other users to

assist them with determining and recording verification of conformity of the equipment under

test with the requirements of
IEC 61010-2-041: 1997,
and
IEC 61010-1: 1990 + amendment 1: 1992

or
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.
Requirements which apply only to amendment 2 to IEC 61010-1 are indicated by "(AM 2)" in
the first column. Requirements deleted by amendment 2 to IEC 61010-1 are indicated by
"(AM 1 only)" in the second column.
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 publication can 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.

TR 61010-3-041  IEC:1999(E) – 5 –

Conformity Verification Report

IEC 61010-2-041
Safety requirements for electrical equipment

for measurement, control, and laboratory use:

Part 2-041: Particular requirements for autoclaves using steam

for the 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 61010-2-041:1995
.................................................................... and
.................................................................... IEC 61010-1:1990 + amendment 1:1992
.................................................................... or
.................................................................... 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 référence .:
Manufacturer.:
Rating.:
Copy of rating plate:
– 6 – TR 61010-3-041  IEC:1999(E)

Description of equipment function:

INSTALLATION/OVERVOLTAGE CATEGORY:

POLLUTION DEGREE:
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 × Width × 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 61010-3-041  IEC:1999(E) – 7 –

Table 1 – Documents attached to this report

Number
Document No. Document description
of pages
– 8 – TR 61010-3-041  IEC:1999(E)

Table 2 – Test equipment list
Calibration date
Equipment
Item Type Comments
No.
1)
Last Due
1)
or interval between calibrations.

TR 61010-3-041 © IEC:1999(E)              – 9 –

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

– 10 – TR 61010-3-041  IEC:1999(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
– PRESSURE VESSEL markings (see 5.1.102)
CHAMBER
If jacket pressure differs from , data for
both marked on PRESSURE VESSEL
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
(AM 2) If more than one voltage range:
– separate values marked
or
– values differ by less than 20 %
(see Form A.3)
F
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-041  IEC:1999(E) – 11 –

Clause
Requirement Result Comments
Subclause
d) equipment which can be set for different RATED

supply voltages:
–for PORTABLE EQUIPMENT, indication is visible
from the exterior
– if the supply voltage can be altered without

the use of a tool, changing the setting also

changes the indication
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
The measured value not more than 110 %
(see Form A.3)
F
5.1.4 Fuses
OPERATOR replaceable fuse marking
(see also 5.4.5)
5.1.5 Measuring circuit TERMINALS
(AM 2) RATED maximum working voltage or current
marked
Unless clear indication that below limits:
– maximum RATED voltage to earth is marked
or
– for specific connection only, and means for
identifying provided
– is adjacent to TERMINALS
or
– if insufficient space
RATING
– on the plate or scale plate
or
– if the TERMINAL is marked with symbol 14
INSTALLATION CATEGORY marked
(AM 2)
TERMINALS permanently connected and not
(AM 2)
ACCESSIBLE
Result: P = Pass  F = Fail  NA = Not Applicable

– 12 – TR 61010-3-041  IEC:1999(E)

Clause
Requirement Result Comments
Subclause
5.1.6 TERMINALS and operating devices

Where necessary for safety, indication of purpose

of TERMINALS, connectors, controls and indicators

(AM 2) Mains supply TERMINALS identified

(AM 2) 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
TERMINALS
c) of measuring and control circuits
d) TERMINALS supplied from the interior
e) ACCESSIBLE FUNCTIONAL EARTH TERMINALS
f) position on or off of power supply switch
(AM 1 only)
aa) NORMAL USE 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)
5.1.8 Battery charging
Equipment with means to charge rechargeable
batteries is marked:
– to warn against the charging of non-
rechargeable batteries
– to indicate the type of rechargeable battery
used
5.1.101 Overpressure safety device
Identification includes:
– model number, etc.
– pressure setting
– if bursting disc:
– pressure
– temperature
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-041  IEC:1999(E) – 13 –

Clause
Requirement Result Comments
Subclause
5.1.102 PRESSURE VESSEL markings

In all cases, markings include

a) name of the manufacturer
b) serial number
c) identification number of door (may be the same
as the serial number)
d) maximum working pressure
e) maximum working temperature
f) minimum working pressure
g) test pressure
h) construction standard applies
i) the CHAMBER volume in litres
5.2 Warning markings
– visible when ready for NORMAL USE
– if necessary marked with symbol 14
– are near or on applicable parts
(AM 2) – statement to isolate or disconnect
ACCESSIBLE
– advice on how to avoid contact with
HAZARDOUS LIVE parts
– TERMINAL voltage exceeding 1 kV (symbol 12)
– easily touched high-temperature parts
(symbol 13)
– warning for more than 2 s (AM 1 only)
– instruction to lock and retain key
LOAD
– type warning
5.3 Durability of markings
The required markings remain clear and legible in
NORMAL USE (see Form A.4)
F
5.4 Documentation
5.4.1 General
Equipment is accompanied by documentation
which includes
– technical specification
Result: P = Pass  F = Fail  NA = Not Applicable

– 14 – TR 61010-3-041  IEC:1999(E)

Clause
Requirement Result Comments
Subclause
– instructions for use
– name and address of manufacturer or supplier

(AM 2) Definition of INSTALLATION CATEGORY

Warning statements and a clear explanation of

warning symbols:
– provided in the documentation

or
– information is marked on the equipment
– PRESSURE VESSEL conformity declaration
– instructions on warning signs for country of use
5.4.2 Equipment RATINGS
Documentation includes
– supply voltage or voltage range
– frequency or frequency range
– power or current RATING
– a description of all input and output
connections
– RATING of insulation of external circuits, when
ACCESSIBLE
such circuits are nowhere
– statement of the range of environmental
conditions
5.4.3 Equipment installation
Documentation includes instructions for
a) location and mounting
b) weights
c) floor loading
d) assembly
e) mains
– supply
– connections
f) protective earthing
g) sound power
– data
– requirements (see 12.5.1)
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-041  IEC:1999(E) – 15 –

Clause
Requirement Result Comments
Subclause
5.4.4 Equipment operation
Instructions for use include
a) operating controls:
– identification
–use
b) not to be positioned so that disconnection is

difficult
c) accessories:
– interconnection
– suitability
– detachable parts
– special materials
d) specification of intermittent operation limits
e) explanation of symbols used
f) cleaning
g) lockable door closure stop:
– correct use
– retain key
h) safe use of the overide key
i) action in case of malfunction
5.4.5 Equipment maintenance
Instructions include
– special precautions for safety
– threaded parts
– safety devices
– replacement of hoses, etc.
(AM 2)
– specific battery type
– any manufacturer specified parts
– RATING and characteristics of fuses
Result: P = Pass  F = Fail  NA = Not Applicable

– 16 – TR 61010-3-041  IEC:1999(E)

Clause
Requirement Result Comments
Subclause
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

Asbestos 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
F (see Form A.7)
6.3.2 Values in SINGLE FAULT CONDITION
(see Form A.8)
F
6.4 Protection in NORMAL CONDITION
(see 6.8 and 8.1)
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 equipment
(see Form A.9)
F
PERMANENTLY CONNECTED
6.5.1.3 Bonding impedance of
EQUIPMENT (see Form A.9)
F
Indirect bonding for measuring and test equipment
6.5.1.4
(see Form A.9)
F
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-041  IEC:1999(E) – 17 –

Clause
Requirement Result Comments
Subclause
6.5.2 DOUBLE INSULATION and REINFORCED INSULATION

(see 6.7, 6.8 and 6.9.2)
6.5.3 PROTECTIVE IMPEDANCE
(see Form A.10)
F
Components wires and connections are RATED as

required
6.5.4 Built-in equipment (AM 1 only)
or
(AM 2) Built-in panel meters
If, after building in, the requirements of 6.5.1 to
6.5.3 are not met:
– equipment (AM 1 only)
or
– panel meter
(AM 2)
– 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:
a) short circuit could not make external circuit
HAZARDOUS LIVE
b) manufacturer's instructions include
TERMINAL
– a statement that the 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
Result: P = Pass  F = Fail  NA = Not Applicable

– 18 – TR 61010-3-041  IEC:1999(E)

Clause
Requirement Result Comments
Subclause
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 internal
F
capacitor (see Form A.7)
High-voltage TERMINALS energized from the interior
are
– not ACCESSIBLE
or
(AM 2) –marked
6.6.3 Circuits with TERMINALS which are HAZARDOUS LIVE
These circuits
– are not connected to ACCESSIBLE conductive
parts
or
– are connected to ACCESSIBLE conductive parts,
but are not mains circuits and have one
TERMINAL contact at earth potential
ACCESSIBLE HAZARDOUS LIVE
No conductive parts are
6.7 CLEARANCES and CREEPAGE DISTANCES
F (see annex D of IEC 61010-1 and Form A.11)
6.8 Dielectric strength tests
(see annex E of IEC 61010-1 and Form A.12)
F
Protection against the spread of fire (see 9.1)
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
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-041  IEC:1999(E) – 19 –

Clause
Requirement Result Comments
Subclause
6.9.2 ENCLOSURES of equipment with DOUBLE

INSULATION or REINFORCED INSULATION

ENCLOSURE 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 (AM 2) Over-range indication
Unambiguous
6.10 Connection to mains supply source (AM 2 only)
or
(AM 2) Connection to mains supply source and
connections between parts of equipment
6.10.1 Mains supply cords
ATED
R for maximum equipment current
(see 5.1.3 c))
Cable complies with IEC 60227 or IEC 60245 or is
a certified cord
(AM 2) Heat resistant if likely to contact hot parts
(AM 2) Temperature RATING (cord and inlet)
Green/yellow used only for connection to
PROTECTIVE CONDUCTOR TERMINALS
Result: P = Pass  F = Fail  NA = Not Applicable

– 20 – TR 61010-3-041  IEC:1999(E)

Clause
Requirement Result Comments
Subclause
Combination of conductors (AM 1 only):

– all have same degree of insulation

or
– no hazard from short circuits

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)
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-041  IEC:1999(E) – 21 –

Clause
Requirement Result Comments
Subclause
6.10.3 Plugs and connectors
a) Mains supply plugs, connectors etc., comply

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

– mains type plugs used only for connection

to mains supply
c) Plug pins which receive a charge from an
internal capacitor (see Form A.7)
F
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
outlet has earth TERMINAL contact
6.11 TERMINALS
6.11.1 ACCESSIBLE TERMINALS
a) No risk of accidental contact (see also 5.1.6 c))
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 supply TERMINALS
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
TERMINALS
supply
e) Soldered connections:
– independently secured
– not used for other purposes
– screw connections are secured
Result: P = Pass  F = Fail  NA = Not Applicable

– 22 – TR 61010-3-041  IEC:1999(E)

Clause
Requirement Result Comments
Subclause
f) Contact surfaces are metal
g) If plug-in, makes first and breaks last

(AM 2) h) Protective conductor of measuring circuit:

– current RATING
– protective bonding:
i) not interrupted
or
ii) indirect bonding
6.11.3 FUNCTIONAL EARTH TERMINALS
Independent connection
6.11.101 Connection of non-detachable mains cords to
TERMINALS
Does not require special preparation of the
conductors
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
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-041  IEC:1999(E) – 23 –

Clause
Requirement Result Comments
Subclause
6.12.3 Disconnecting devices
Electrically close to the supply

6.12.3.1 Switches and circuit-breakers

When used as disconnection device:

– meets 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
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
Power interruption and partial interruption
(see Form A.1, 7.2.101.4 and 11.102)
F
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
SINGLE FAULT CONDITION
Threaded parts
Result: P = Pass  F = Fail  NA = Not Applicable

– 24 – TR 61010-3-041  IEC:1999(E)

Clause
Requirement Result Comments
Subclause
7.2 Moving parts
Moving parts not able to crush, etc.

(see also 6.12.2.3)
(AM 2) If OPERATOR 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
a) residual movement
b) returns to safe condition
c) key, etc. for reset
7.2.101.2 Door motion reversal and stoppage
Device reverses the motion of the door upon
encountering an obstruction (see Form A.30)
F
7.2.101.3 Sliding doors
Door speed and distance (see Form A.30)
F
7.2.101.4 Interruption of power supply
Emergency shut-down device operates
7.2.102 Bell-shaped PRESSURE VESSELS
– guard in place
– two hands > 1 m apart
Shut-down device provided (see 7.2.101.1)
a) residual movement
b) return to safe condition
c) key, etc. for reset
F Motion reversal and stoppage (see Form A.30 and
7.2.101.2)
Sliding door loss of power (see Form A.30 and
F
7.2.101.3)
Emergency shut-down device on interruption of
power supply, see 7.2.101.4
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-041  IEC:1999(E) – 25 –

Clause
Requirement Result Comments
Subclause
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 Provisions for transferring the LOAD into and
out of the AUTOCLAVE
Protection against mechanical hazards
LOAD location and retention
Prevention of shelf tilting or disengaging
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
See f) for AUTOCLAVES < 50 bar litres:
a) interlocks fitted, application of a 1 000 N force
does not permit access
b) no steam or compressed air entering or

generated until door closed with pressure
retaining parts engaged (>50 bar litres)
OPERATING CYCLE
c) interlock failure prevented
d) pressure-retaining parts not fully released until
CHAMBER vented
e) seal not broken before pressure within 0,2 bar
of atmospheric (>50 bar·litres)
Result: P = Pass  F = Fail  NA = Not Applicable

– 26 – TR 61010-3-041  IEC:1999(E)

Clause
Requirement Result Comments
Subclause
f) AUTOCLAVES <50 bar·litres:
– meet a), c) and d) above
or
CHAMBER
– vent before access to the door

release
7. 101.2 Door interlocks for AUTOCLAVES specified for use

with fluids in containers
a) door opening prevented until specified

temperature reached
b) interlock for unvented containers cannot be
released until specified temperature reached
7. 101.3 Door interlocks for double-ended
AUTOCLAVES
OPERATOR cannot operate remote door (except
automatic loading where OPERATOR not
involved)
7. 102 Doors with inflatable or pressure-activated
seals
If pressure falls below minimum:
a) OPERATING CYCLE terminates
b) alarm indicates fault condition
c) door remains closed
d) fluid entry into CHAMBER prevented
e) no hazard is caused
7. 103 Prevention of door closure
Device to prevent door closing, with lock and
dedicated key
or
– Emergency shutdown control operable from
within the CHAMBER
or
–CHAMBER depth < 1 m and volume < 0,65 m

8 Mechanical resistance to shock, vibration and
impact (AM 1 only)
or
(AM 2) Mechanical resistance to shock and impact
F After the tests of 8.1 to 8.4 (see Form A.11):
F – voltage tests (see Form A.12)
– inspection, equipment meets the following
requirements:
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-041  IEC:1999(E) – 27 –

Clause
Requirement Result Comments
Subclause
a) hazardous live parts not ACCESSIBLE

ENCLOSURE
b) shows no cracks (hazard)
c) CLEARANCES not less than their permitted

values (see Form A.11)
F
– 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
(see Form A.14)
F
or
– method of annex F
F (see Forms A.15, A.16 and A.17)
Asbestos not used for thermal insulation
9.2 Temperature tests
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
TERMINALS
– adjacent to field-wiring
or
– visible during and after installation
Result: P = Pass  F = Fail  NA = Not Applicable

– 28 – TR 61010-3-041  IEC:1999(E)

Clause
Requirement Result Comments
Subclause
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
Protection devices to limit the CHAMBER wall
temperature
Overtemperature protection:
– separate from temperature control
– not self-resetting
– does not require soldering for resetting
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 DISTANCES
F (see Form A.11)
10.2 Resistance to heat of non-metallic ENCLOSURE
F (see Form A.19)
10.3 Resistance to heat of insulation material
Parts supporting:
– parts connected to mains supply
– TERMINALS carrying >0,5 A
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-041  IEC:1999(E) – 29 –

Clause
Requirement Result Comments
Subclause
11 Resistance to moisture and liquids (AM 1 only)

or
(AM 2) 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 Liquid leakage (AM 1 only)
11.5.1 Equipment containing liquid (AM 1 only)
(see Form A.20)
F
11.5.2 Battery electrolyte (AM 1 only)
or
11.5  (AM 2) Battery electrolyte
Battery electrolyte leakage presents no hazard
11.5.101 Discharge of residual water from the CHAMBER
No hazard from discharge
11.5.102 Indicator and interlock for residual water
No hazard if water is present
11.6 Specially protected equipment
F (see Form A.20)
11.7 (AM 2) Fluid pressure and leakage
11.7.1 (AM 2) Maximum pressure not exceeded
11.7.2 (AM 2) Leakage and rupture at high pressure
(see Form A.21)
F
Test to IEC 60335 (refrigeration only)
11.7.3 (AM 2) Leakage from low-pressure parts
(see Form A.21)
F
11.7.4 (AM 2) Overpressure safety device
CHAMBER
Where possible to exceed maximum
working pressure:
– overpressure device fitted
and
– device set to operate at a pressure � the
maximum working pressure
STERILIZER CHAMBER pressure cannot be more than
10 % above the maximum working pressure
Result: P = Pass  F = Fail  NA = Not Applicable

– 30 – TR 61010-3-041  IEC:1999(E)

Clause
Requirement Result Comments
Subclause
Safety device drain
has:
– drain connection at lowest point

and
– discharge to a safe place
or
– other provisions
Safety device does not operate in NORMAL USE

and
– shall comply with the following:
– positioned close to parts intended to be
protected
– properly mounted
– direct short pipe
– 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
11.7.101 Instruments and indicating devices
If necessary for safety:
CHAMBER
a) pressure indicator
b) jacket pressure indicator
c) OPERATING CYCLE counter
11.101 Discharge from pressure-venting valves and
overpressure safety devices
a) Discharge:
– no hazard
– pipe requirements
b) Discharge inside cabinet:
– jacket vented
OPERATOR
– cannot reach
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-041  IEC:1999(E) – 31 –

Clause
Requirement Result Comments
Subclause
11.102 Interruption of supplies and services

Not cause safety systems to be circumvented and

no hazard (see Form A.1)
F
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 Microwave radiation
(Conformity test and limit of 10 W/m
are under consideration)
12.5 Sonic and ultrasonic pressure
12.5.1 Sound pressure level (AM 1 only)
(see Form A.23)
F
or
(AM 2) Sound level
F (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
Any data/test reports used to demonstrate
conformity attached
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
Result: P = Pass  F = Fail  NA = Not Applicable

– 32 – TR 61010-3-041  IEC:1999(E)

Clause
Requirement Result Comments
Subclause
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
13.3 Implosion of high-vacuum devices
High-vacuum devices:
– intrinsically protected and correctly mounted
or
– ENCLOSURE provides protection:
– screen not removable without TOOL
– if glass screen, not in contact
13.101 CHAMBER exhaust system
Discharge no hazard
13.102 LOAD access after a fault
No safety device disabled
13.103 Interruption of supplies and services
F (see Form A.1)
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
(see Form A.25)
F
No hazard from stopped motor
Loss of one phase no hazard
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-041  IEC:1999(E) – 33 –

Clause
Requirement Result Comments
Subclause
14.2.2 Series excitation motors

14.3 Overtemperature protection devices

Devices oper
...