IEC/TR 61010-3-042

SLOVENSKI STANDARD
01-maj-2002
Safety requirements for electrical equipment for measurement, control, and
laboratory use - Part 3-042: Conformity verification report for IEC 61010-2-042:1997
- Particular requirements for autoclaves and sterilizers using toxic gas for the
treatment of medical materials, and for laboratory precesses
Safety requirements for electrical equipment for measurement, control, and laboratory
use - Part 3-042: Conformity verification report for IEC 61010-2-042:1997, Particular
requirements for autoclaves and sterilizers using toxic gas for the treatment of medical
materials, and for laboratory processes
Ta slovenski standard je istoveten z: IEC/TR 61010-3-042
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 61010-3-042
First edition
1999-10
Safety requirements for electrical equipment
for measurement, control, and laboratory use –
Part 3-042:
Conformity verification report for
IEC 61010-2-042:1997, Particular requirements
for autoclaves and sterilizers using toxic gas
for the treatment of medical materials, and for
laboratory processes
Règles de sécurité pour appareils électriques de mesurage,
de régulation et de laboratoire –
Partie 3-042:
Rapport de vérification de la conformité de la
CEI 61010-2-042:1997, Prescriptions particulières pour
autoclaves et stérilisateurs utilisant des gaz toxiques
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 61010-3-042  IEC:1999(E)
CONTENTS
Page
FOREWORD . 3
Conformity verification report IEC 61010-3-042 . 5
Clause
5 Marking and documentation. 10
6 Protection against electric shock . 17
7 Protection against mechanical hazards. 25
8 Mechanical resistance to shock and impact . 27
9 Equipment temperature limits and protection against the spread of fire . 28
10 Resistance to heat . 29
11 Protection against hazards from fluids . 29
12 Protection against radiation, including laser sources, and against sonic and
ultrasonic pressure. 31
13 Protection against liberated gases, explosion and implosion . 32
14 Components. 35
15 Protection by interlocks . 38
16 Measuring circuits . 38
Annex K . 38
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 .39 to 68

TR 61010-3-042  IEC:1999(E) – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
__________
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT
FOR MEASUREMENT, CONTROL, AND LABORATORY USE –
Part 3-042: Conformity verification report for IEC 61010-2-042:1997,
Particular requirements for autoclaves and sterilizers using
toxic gas 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 61010-3-042, 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
66/194/CDV 66/218/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 61010-3-042  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 61010-2-042: 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 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 61010-3-042  IEC:1999(E) – 5 –
Conformity Verification Report
IEC 61010-2-042
Safety requirements for electrical equipment
for measurement, control, and laboratory use:
Part 2-042: Particular requirements for autoclaves and sterilizers using toxic gas
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 61010-1:1990 + amendment 1:1992+ amendment 2:1995
.................................................................... IEC 61010-2-042: 1997
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 .: � Measurement � Control � Laboratory
Trademark. .:
Model/type référence .:
Manufacturer.:
Rating.:
Copy of rating plate:
– 6 – TR 61010-3-042  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 61010-3-042  IEC:1999(E) – 7 –
Table 1 – Documents attached to this report
Number
Document No. Document description
of pages
– 8 – TR 61010-3-042  IEC:1999(E)
Table 2 – Test equipment list
Calibration date
Equipment
Item Type Comments
No.
1)
Last Due
1)
or interval between calibrations.

TR 61010-3-042 © 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 61010-3-042  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
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 61010-3-042  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
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
TERMINALS permanently connected and not
ACCESSIBLE
Result: P = Pass  F = Fail  NA = Not Applicable

– 12 – TR 61010-3-042  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
Mains supply TERMINALS identified
Power supply switch on or off position marked if
used as disconnecting device
TERMINAL marking:
a) FUNCTIONAL EARTH TERMINALS
PROTECTIVE CONDUCTOR TERMINALS
b) :
– 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
aa) NORMAL USE setting a control could cause
a harzard, 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 61010-3-042  IEC:1999(E) – 13 –
Clause
Requirement Result Comments
Subclause
5.1.102 PRESSURE VESSEL markings
Markings comply with the regulations and codes
applicable in the country of intended use
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
CHAMBER
i) the 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
– 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)
– instruction to lock and retain key
– to indicate any hazardous properties of the
sterilant gas
– LOAD type warning
5.3 Durability of markings
The required markings remain clear and legible in
F NORMAL USE (see Form A.4)
Result: P = Pass  F = Fail  NA = Not Applicable

– 14 – TR 61010-3-042  IEC:1999(E)
Clause
Requirement Result Comments
Subclause
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
– PRESSURE VESSEL conformity declaration
– emergency guidelines
– instructions on warning signs for country of use
Definition of INSTALLATION CATEGORY
Warning statements and a clear explanation of
warning symbols:
– provided in the documentation
or
– information is marked on the equipment
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
such circuits are nowhere ACCESSIBLE
– statement of the range of environmental
conditions
– the RATED maximum leak rate:
a) air in
b) air or sterilant out
5.4.3 Equipment installation
Documentation includes instructions for
– assembly, location and mounting
– protective earthing
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-042  IEC:1999(E) – 15 –
Clause
Requirement Result Comments
Subclause
– connections to supply
– ventilation requirements
– special services
– maximum sound power level
– instructions about sound pressure
Additional for permanently connected equipment:
– supply wiring
– any external switch or circuit-breaker (including
location)
– any external overcurrent protection
5.4.3.1 Assembly and installation instructions
Instructions include
a) – location
– mounting
– maintenance space
b) – component weights
– overall weight
c) floor loading
d) assembly
e) – mains supply
– mains connections
f) protective earthing
g) – sound power data
– sound power requirements
h) hazardous gas atmospheres
5.4.3.2 Requirements for special services
Installation instructions for
a) non-recirculating ventilation system
b) separate space ventilation sensing device
c) non-recirculating local exhaust system
d) drainage system
Result: P = Pass  F = Fail  NA = Not Applicable

– 16 – TR 61010-3-042  IEC:1999(E)
Clause
Requirement Result Comments
Subclause
e) drain venting system
CHAMBER
f) exhaust system
g) – steam supply
– steam drain
5.4.3.3 For permanently connected equipment
– external switch or circuit breaker
– external overcurrent protection device
5.4.4 Equipment operation
5.4.4.1 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) limits for intermittent operation
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
5.4.4.2 Consumable materials
Instructions given for inspection, replacement and
storage
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-042  IEC:1999(E) – 17 –
Clause
Requirement Result Comments
Subclause
5.4.4.3 OPERATOR training
Instructions for RESPONSIBLE BODY:
a) to arrange operation and safety training
b) to supervise sterilization procedures
c) comprehensive instructions for personnel
working with toxic gas:
– health hazard
– national regulations
– safe use
– leak detection
d) in-service programmes:
– conducted
– attendance records
– evidence of understanding
5.4.5 Equipment maintenance
Instructions include
– special precautions for safety
– threaded parts
– safety devices
– sufficient preventive maintenance and
inspection information
– 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
Asbestos not used
6.1.1 Exceptions
F Capacitance test (see Forms A.6 and A.7)
Result: P = Pass  F = Fail  NA = Not Applicable

– 18 – TR 61010-3-042  IEC:1999(E)
Clause
Requirement Result Comments
Subclause
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
F (see Form A.8)
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
CCESSIBLE
A conductive parts:
– bonded to the protective conductor terminal
or
– separated by screen or BARRIER from parts

HAZARDOUS LIVE
which are
(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
6.5.1.3 Bonding impedance of PERMANENTLY CONNECTED
EQUIPMENT (see Form A.9)
F
6.5.1.4 Indirect bonding for measuring and test equipment
(see Form A.9)
F
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
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-042  IEC:1999(E) – 19 –
Clause
Requirement Result Comments
Subclause
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
DOUBLE REINFORCED INSULATION
– has / of
ACCESSIBLE surface of parts intended to be
grasped
6.6 External circuits
6.6.1 Separation of internal circuits
(see list in Forms A.1 and A.5)
F
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
– 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
CCESSIBLE TERMINALS HAZARDOUS LIVE
A are not
except as permitted by 6.1.1
The following terminals are not hazardous live:
PROTECTIVE CONDUCTOR TERMINALS
–
– FUNCTIONAL EARTH TERMINALS
– headphone TERMINALS
F TERMINALS which receive a charge from an internal
capacitor (see Form A.7)
High-voltage TERMINALS energized from the interior
are
– not ACCESSIBLE
or
–marked
Result: P = Pass  F = Fail  NA = Not Applicable

– 20 – TR 61010-3-042  IEC:1999(E)
Clause
Requirement Result Comments
Subclause
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 Form A.11)
F
6.8 Dielectric strength tests
F (see annex E of IEC 61010-1 and Form A.12)
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
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
ENCLOSURES 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
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-042  IEC:1999(E) – 21 –
Clause
Requirement Result Comments
Subclause
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
Unambiguous
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 5.1.3 c))
Cable complies with IEC 60227 or IEC 60245 or is
a certified cord
Heat resistant if likely to contact hot parts
Temperature RATING (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
Result: P = Pass  F = Fail  NA = Not Applicable

– 22 – TR 61010-3-042  IEC:1999(E)
Clause
Requirement Result Comments
Subclause
– 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
Push-pull test (see Form A.13)
F
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 T
ERMINALS
6.11.1 A
CCESSIBLE TERMINALS
a) No risk of accidental contact (see also 5.1.6 c))
b) Will not work loose
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-042  IEC:1999(E) – 23 –
Clause
Requirement Result Comments
Subclause
6.11.2 PROTECTIVE CONDUCTOR TERMINAL
a) Appliance inlet (no requirement)
PERMANENTLY
b) For rewirable cords and
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
TERMINALS
– external if other external
d) Equivalent current-carrying capacity to mains
supply TERMINALS
e) Soldered connections:
– independently secured
– 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
– 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
Result: P = Pass  F = Fail  NA = Not Applicable

– 24 – TR 61010-3-042  IEC:1999(E)
Clause
Requirement Result Comments
Subclause
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:
– 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
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-042  IEC:1999(E) – 25 –
Clause
Requirement Result Comments
Subclause
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
7.2 Moving parts
Moving parts not able to crush, etc.
(see also 6.12.2.3)
If OPERATOR access permitted:
TOOL
a) access requires
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 the mains supply
Does not cause any safety system to be
circumvented and no hazard arises
Result: P = Pass  F = Fail  NA = Not Applicable

– 26 – TR 61010-3-042  IEC:1999(E)
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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 CHAMBER
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
Interlocks prevent:
a) hazardous access, 1 000 N applied
CHAMBER
b) no gas enters until door secured
c) interlock failure OPERATING CYCLE 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)
f) AUTOCLAVES <50 bar·litres
– meet a), c) and d) above
or
CHAMBER
– vent before access to the door
release
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-042  IEC:1999(E) – 27 –
Clause
Requirement Result Comments
Subclause
7.101.2 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 and gas does not escape
d) ventilation operates
e) sterilant gas isolating valve automatically
operated
f) complete system is evacuated to the discharge
pipe
g) if sterilant is flammable, system is purged using
air or inert gas
h) 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
CHAMBER
within the
or
–CHAMBER depth < 0,7 m and volume < 0,4 m
8 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:
ACCESSIBLE
a) hazardous live parts not
b) ENCLOSURE shows no cracks (hazard)
c) CLEARANCES not less than their permitted
F 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
Result: P = Pass  F = Fail  NA = Not Applicable

– 28 – TR 61010-3-042  IEC:1999(E)
Clause
Requirement Result Comments
Subclause
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
9.5 Overtemperature protection devices
– fitted, to operate in SINGLE FAULT CONDITION
F (see Form A.1)
– 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
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-042  IEC:1999(E) – 29 –
Clause
Requirement Result Comments
Subclause
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
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)
Result: P = Pass  F = Fail  NA = Not Applicable

– 30 – TR 61010-3-042  IEC:1999(E)
Clause
Requirement Result Comments
Subclause
11.7 Fluid pressure and leakage
Maximum pressure not exceeded
11.7.1
Leakage and rupture at high pressure
11.7.2
(see Form A.21)
F
Test to IEC 60335 (refrigeration only)
Leakage from low-pressure parts
11.7.3
(see Form A.21)
F
11.7.4 Overpressure safety device
Where possible to exceed maximum CHAMBER
working pressure:
– overpressure device fitted
and
– device set to operate at a pressure the
maximum working pressure
– does not exceed maximum working pressure by
more than 10 %
– no discharge during NORMAL USE
– no accumulation of water on seating
– discharge to a safe place
Does not operate in NORMAL USE
and
Complies with the following:
– positioned close to parts intended to be
protected
– mounted according to instructions
– connected by the shortest length of 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
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-042  IEC:1999(E) – 31 –
Clause
Requirement Result Comments
Subclause
11.7.101 Instruments and indicating devices
If necessary for safety:
CHAMBER
a) pressure indicator
b) jacket pressure indicator
c) OPERATING CYCLE counter
d) supply line pressure indicator
e) leak detection
F Indicators operate in SFC (see Form A.2)
11.101 Discharge from pressure-venting valves and
overpressure safety devices
a) Discharge:
– no hazard
– pipe requirements
b) Discharge inside cabinet:
– cabinet vented
– cannot reach OPERATOR
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
(Conformity test under consideration)
12.3 Ultra-violet radiation
12.4 Microwave 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)
Result: P = Pass  F = Fail  NA = Not Applicable

– 32 – TR 61010-3-042  IEC:1999(E)
Clause
Requirement Result Comments
Subclause
13 Protection against liberated gases,
explosion and implosion
13.1 Poisonous and injurious gases
a) Any data/test reports used to demonstrate
conformity attached
b) – parts do not react with sterilant or carrier gas
and
– liberation of gas does not cause a hazard
13.1.101 CHAMBER leakage
– leakage test before sterilant gas admitted
– shutdown if level exceeded
13.1.102 Non-return valve in the air inlet pipe
Non-return valve operating above atmospheric
pressure
13.1.103 Protection from hazards before any door can be
opened
PERATING CYCLE
13.1.103.1 O includes sterilant removal to
below flammable limit
Means provided so no hazard when left in a closed
13.1.103.2
unventilated condition
13.1.104 Protection against gases liberated from the
LOAD
13.1.104.1 The sterilant removal stage is followed by
– flushing stage
or
– multiple evacuations
and
– door does not open until completion
13.1.104.2 No hazard from desorption of sterilant from LOAD
13.1.105 Failure of CHAMBER exhaust system
– audible and visible warning signals
– OPERATING CYCLE is not initiated
or
LOAD
– if cycle in progress, access to prevented
until exhaust system is operational
13.1.106 Failure of space ventilation system
Terminals for sensing device
Result: P = Pass  F = Fail  NA = Not Applicable

TR 61010-3-042  IEC:1999(E) – 33 –
Clause
Requirement Result Comments
Subclause
13.1.107 Failure of sensor or timer
Visible alarm to indicate hazard
If failure occurs:
– OPERATING CYCLE not initiated
or
– if cycle in progress, access to LOAD prevented
until sterilant removed
13.1.108 Protection against gases liberated from the
drain
Discharge to a safe place
13.1.109 Local exhaust ventilation
Connected to remove fugitive emissions
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
Parts do not react with sterilant or carrier gas to
cause explosion or implosion
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

– 34 – TR 61010-3-042  IEC:1999(E)
Clause
Requirement Result Comments
Subclause
13.2.101 Heating of sterilant
– No hazard when containers subject to direct
heating
– Sterilant liquids have no direct contact with
electrical heating element
– Parts do not have a temperature to cause fire,
explosion or other hazard
13.2.102 Flammable sterilants
– Equipment has no source of ignition
and
–OPERATING CYCLE includes air removal stage
13.2.103 Electrical requirements
13.2.103.1 Hazardous area classification and requirements
Hazardous area according to IEC 60079:
– classified
–protected
13.2.103.2 Bonding of electrically conductive compone
...