IEC TR 61010-3-045:2003

TECHNICAL IEC
REPORT
TR 61010-3-045
First edition
2003-04
Safety requirements for electrical equipment
for measurement, control, and laboratory use –
Part 3-045:
Conformity verification report for
IEC 61010-2-045:2000 –
Particular requirements for washer disinfectors
used in medical, pharmaceutical, veterinary
and laboratory fields
Règles de sécurité pour appareils électriques
de mesurage, de régulation et de laboratoire –
Partie 3-045:
Rapport de vérification de la conformité
de la CEI 61010-2-045:2000 –
Prescriptions particulières pour appareils de désinfection/
lavage utilisés dans les domaines médical, pharmaceutique,
vétérinaire et en laboratoire
Reference number
IEC/TR 61010-3-045:2003(E)
Publication numbering
As from 1 January 1997 all IEC publications are issued with a designation in the

60000 series. For example, IEC 34-1 is now referred to as IEC 60034-1.

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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.
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TECHNICAL IEC
REPORT
TR 61010-3-045
First edition
2003-04
Safety requirements for electrical equipment
for measurement, control, and laboratory use –
Part 3-045:
Conformity verification report for
IEC 61010-2-045:2000 –
Particular requirements for washer disinfectors
used in medical, pharmaceutical, veterinary
and laboratory fields
Règles de sécurité pour appareils électriques
de mesurage, de régulation et de laboratoire –
Partie 3-045:
Rapport de vérification de la conformité
de la CEI 61010-2-045:2000 –
Prescriptions particulières pour appareils de désinfection/
lavage utilisés dans les domaines médical, pharmaceutique,
vétérinaire et en laboratoire
 IEC 2003  Copyright - all rights reserved
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mechanical, including photocopying and microfilm, without permission in writing from the publisher.
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International Electrotechnical Commission
Международная Электротехническая Комиссия
For price, see current catalogue

– 2 – TR 61010-3-045  IEC:2003(E)

CONTENTS
FOREWORD . 3

Conformity verification report for IEC 61010-2-045:2000 . 5

5 Marking and documentation .11

6 Protection against electric shock.16

7 Protection against mechanical hazards .22

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 .24
12 Protection against radiation, including laser sources, and against sonic and
ultrasonic pressure .26
13 Protection against liberated gases, explosion and implosion and pathogenic
substances .26
14 Components .27
15 Protection by interlocks.29
16 Measuring circuits.29
Annex K – Routine tests.29
Table 1 – Documents attached to this report . 8
Table 2 – Test equipment list . 9
Table 3 – List of components relied on for safety .10
Form A.1 to Form A.31.30 to 62

TR 61010-3-045  IEC:2003(E) – 3 –

INTERNATIONAL ELECTROTECHNICAL COMMISSION

___________
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT

FOR MEASUREMENT, CONTROL, AND LABORATORY USE –

Part 3-045: Conformity verification report for IEC 61010-2-045:2000 –

Particular requirements for washer disinfectors used in

medical, pharmaceutical, veterinary and laboratory fields

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 61010-3-045, 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:
Committee draft Report on voting
66/274/CDV 66/301/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.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

– 4 – TR 61010-3-045  IEC:2003(E)

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 users to assist them with

determining and recording verification of conformity of the equipment under test with the

requirements of:
IEC 61010-2-045: 2000
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 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.
The committee has decided that the contents of this publication will remain unchanged until
2005. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
TR 61010-3-045  IEC:2003(E) – 5 –

Conformity Verification Report

IEC 61010-2-045
Safety requirements for electrical equipment
for measurement, control, and laboratory use

Particular requirements for washer disinfectors used in

medical, pharmaceutical, veterinary and laboratory fields

Report reference No.:

Compiled by (+ signature).:
Approved by (+ signature).:
Date of issue.:
Testing organization.:
Address.:
Testing location .:
Applicant.:
Address.:

Standard.: IEC 61010-2-045: 2000 and IEC 61010-1:1990 + A 1:1992 + A 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.:

– 6 – TR 61010-3-045  IEC:2003(E)

Type of item tested.:    Measurement   Control    Laboratory

Trademark. .:

Model/type reference.:

Manufacturer.:

Rating.:
Copy of rating plate:
TR 61010-3-045  IEC:2003(E) – 7 –

Description of equipment function.:

INSTALLATION/OVERVOLTAGE CATEGORY:

POLLUTION DEGREE:
Environmental rating: Standard Other (specify):

Equipment mobility: Portable Hand-held Floorstanding Fixed
Built in Bench mounted 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.

– 8 – TR 61010-3-045  IEC:2003(E)

Table 1 – Documents attached to this report

Document No Document description Number of

pages
TR 61010-3-045  IEC:2003(E) – 9 –

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

– 10 –         TR 61010-3-045  IEC:2003(E)

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

TR 61010-3-045  IEC:2003(E) – 11 –

Clause Requirement - Test Result Comments Verdict

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
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
F – values differ by less than 20 % (see Form A.3)
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
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

– 12 – TR 61010-3-045  IEC:2003(E)

Clause Requirement - Test Result Comments Verdict

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
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:
– on the RATING plate or scale plate
or
– if the TERMINAL is marked with
symbol 14
INSTALLATION CATEGORY marked
TERMINALS permanently connected and not
ACCESSIBLE
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
In normal use, change of setting a control
could not cause a hazard, an indicating
device is provided
TR 61010-3-045  IEC:2003(E) – 13 –

Clause Requirement - Test Result Comments Verdict

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 re-
chargeable 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.
Manufacturer's pressure setting :.
If bursting disc:
pressure :.
temperature :.
5.1.102 Pressure vessel markings
Markings comply with the pressure vessel
regulations and codes in the country of
intended use
or
The markings include:
a) Name of manufacturer
b) Serial number
c) Maximum working pressure
d) Maximum working temperature
e) Date of manufacture
f) Minimum working pressure (if below
atmospheric)
g) Construction standard applied
h) 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
– statement to isolate or disconnect
– advice how to avoid contact with
ACCESSIBLE HAZARDOUS LIVE parts
TERMINAL voltage exceeding 1 kV
(symbol 12)
– easily touched high temperature parts
(symbol 13)
If lockable door, to lock and retain key
Symbol 14 permanently visibly marked if:
a) Materials have hazardous properties
b) Effluent discharged into drain could
cause a hazard
– 14 – TR 61010-3-045  IEC:2003(E)

Clause Requirement - Test Result Comments Verdict

c) Biological or other hazardous materials
remain in CHAMBER after OPERATING CYCLE

failure
d) Replenishment of toxic materials could

cause a hazard
5.3 Durability of markings
F The required markings remain clear and (see Form A.4)

legible in NORMAL USE
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
Pressure vessel conformity declaration
Instructions on warning signs for country of
use
Emergency guidelines
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
5.4.3 Equipment installation
5.4.3.1 Installation and assembly instructions
Documentation includes instructions for:
a) Floor loading requirements
b) Weights of heavy sub-assemblies
c) Maintenance space
Ease of disconnection
d) Assembly
e) Protective earthing
f) Mains supply:
– Requirements
– Connections
Temperature rating of cable
TR 61010-3-045  IEC:2003(E) – 15 –

Clause Requirement - Test Result Comments Verdict

g) Sound power data
h) Hazardous substances:
Handling
Containment
Additional equipment for control of

emissions
i) Requirements for system to control

escaping biological emissions
5.4.3.2 Special non-electrical supplies and systems

Installation instructions include:
a) Non-recirculating exhaust system
b) Drainage system
c) Any other non-electrical supplies
5.4.3.3 Permanently connected equipment
Instructions for:
a) External switch or circuit-breaker
b) External overcurrent protection device
c) Switch or circuit-breaker located near
equipment
5.4.4 Equipment operation
Instructions for use include:
a) Operating controls:
1) identification
2) use
b) Accessories and other equipment:
Interconnection
Suitability
Detachable parts
Special materials
c) Limits for intermittent operation
d) Explanation of symbols used
e) Cleaning
f) Decontamination after incomplete
operation cycle
g) Lockable door closure stop:
Correct use
Retain key or other means
h) Safe use of the override key
i) Action in case of malfunction
j) Maximum quantities of chemical
substances
k) Loading procedure
l) Testing function of critical safety devices
5.4.4.2 Consumable materials
Instructions for inspections, replacement
and storage, including hazard protection
5.4.4.3 Operator training
Instructions for responsible body:

– 16 – TR 61010-3-045  IEC:2003(E)

Clause Requirement - Test Result Comments Verdict

a) Personnel training
b) Comprehensive instructions for
personnel working with toxic materials:

Process
Health hazard
Leak detection methods
c) In-service programmes:
– Conducted
– Attendance records
– Evidence of understanding
5.4.5 Equipment maintenance, repair and
disposal
Instructions include:
a) Maintenance on threaded parts
b) Safety devices fitted
c) Decontamination prior to maintenance
d) Maintenance schedules and repair
procedures
e) Safe disposal
6   F Protection against electric shock (see Form A.5)
6.1 General
Asbestos not used
Conformity is checked by the determination
of 6.2 and 6.3 followed by the tests of 6.4 to
6.12
6.1.1 Exceptions
F Capacitance test (see Forms A.6 and A.7)
6.2  F Determination of ACCESSIBLE parts (see Form A.6)
6.3 Permissible limits for ACCESSIBLE parts
6.3.1 F Values in NORMAL CONDITION (see Form A.7)
6.3.2 F Values in SINGLE FAULT CONDITION (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
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)
TR 61010-3-045  IEC:2003(E) – 17 –

Clause Requirement - Test Result Comments Verdict

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 F Bonding impedance of plug-connected (see Form A.9)

equipment
6.5.1.3 F Bonding impedance of PERMANENTLY (see Form A.9)

CONNECTED EQUIPMENT
6.5.1.4 F Indirect bonding for measuring and test (see Form A.9)
equipment
6.5.2 DOUBLE INSULATION and REINFORCED
INSULATION (see 6.7, 6.8 and 6.9.2)
6.5.3  F PROTECTIVE IMPEDANCE (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:
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
(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:
– 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
– 18 – TR 61010-3-045  IEC:2003(E)

Clause Requirement - Test Result Comments Verdict

F TERMINALS which receive a charge from an (see Form A.7)
internal capacitor
High-voltage TERMINALS energised from the

interior are:
– not ACCESSIBLE
or
–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
No ACCESSIBLE conductive parts are
HAZARDOUS LIVE
6.7  F CLEARANCES and CREEPAGE DISTANCES (See annex D of IEC 61010-1 and
Form A.11)
6.8  F Dielectric strength tests (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
d) Mains passed through the equipment
e) Protective earthing conductors

TR 61010-3-045  IEC:2003(E) – 19 –

Clause Requirement - Test Result Comments Verdict

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 5.1.3c)
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
Not used to attach any other components
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
– 20 – TR 61010-3-045  IEC:2003(E)

Clause Requirement - Test Result Comments Verdict

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)

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
– mains type plugs used only for
connection to mains supply
F c) Plug pins which receive a charge from (see Form A.7)
an internal capacitor
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
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 rewireable 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 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
TR 61010-3-045  IEC:2003(E) – 21 –

Clause Requirement - Test Result Comments Verdict

6.11.3 FUNCTIONAL EARTH TERMINALS

Independent connection
6.11.101 Connection of non-detachable mains cords

to TERMINALS
No special preparation of conductor ends

No damage
No slip-out of conductors possible

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
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):
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Clause Requirement - Test Result Comments Verdict

– 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
F Interruption of the supply does not cause: (see Form A.1)

Any safety system to be disabled
A hazard
7 Protection against mechanical hazards
7.1 General
Not a hazard in NORMAL USE
Protection against expelled parts under
SINGLE FAULT CONDITION
Asbestos not used for mechanical parts
Conformity is checked by 7.2 to 7.102
7.2 Moving parts
Moving parts not able to crush, etc. (see
also 6.12.2.3)
If OPERATOR access permitted:
a) access requires TOOL
b) statement about training
c) warning markings or symbol 14
7.2.101 Doors
F Door provided with: (see Form A.30)
a guard;
or
interlock system;
or
device which halts;
or
reverse motion device
7.2.102 Manually operated door
F Required force does not exceed 250 N (see Form A.31)
7.3 Stability
Physically stable in NORMAL USE
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
7.4.101 Means for transferring the load into and out
of the chamber
Means to protect OPERATOR against
mechanical hazard
TR 61010-3-045  IEC:2003(E) – 23 –

Clause Requirement - Test Result Comments Verdict

Means to prevent shelf tilting or
disengaging
F Force required for loading / unloading does (see Form A.31)

not exceed 250 N
7.5 Expelled parts
Equipment contains or limits the energy

Protection not removable without the aid of

a TOOL
7.101 Protection when the CHAMBER is accessed
While OPERATOR in CHAMBER means
provided to prevent:
a) Inadvertent operation:
b) Door closing
Means locked by key or Tool
Manufacturer's instructions specify
retention of key or tool
7.102 Emergency stop device
Prominently placed emergency stop device
When device operated, all components
return to safe condition
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:
a) hazardous live parts not accessible
b) ENCLOSURE shows no cracks (hazard)
Fc) CLEARANCES not less than their permitted (see Form A.11)
values
– 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:
F – 9.2 and fault tests of 4.4 (see Forms A.1, A.2 and A.18)
or
F – measurement of CREEPAGE DISTANCE and (see Form A.14)
CLEARANCE and the voltage tests of annex
G
or
F – method of annex F (see Forms A.15, A.16 and A.17)
Asbestos not used for thermal insulation
9.2 Temperature tests
9.3 Guards
F Surfaces liable to exceed 100 °C: (see Form A.18)

– 24 – TR 61010-3-045  IEC:2003(E)

Clause Requirement - Test Result Comments Verdict

– 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
– marked adjacent to field-wiring
TERMINALS
Cable temperature RATING specified by
manufacturer
9.5 Overtemperature protection devices
F Fitted, to operate in SINGLE FAULT CONDITION (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
Entirely separated from temperature control
systems
Not self-resetting
Not resettable by soldering
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  F Integrity of CLEARANCE and CREEPAGE (see Form A.11)
DISTANCES
10.2  F Resistance to heat of non-metallic (see Form A.19)
ENCLOSURE
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)

TR 61010-3-045  IEC:2003(E) – 25 –

Clause Requirement - Test Result Comments Verdict

11.4  F Overflow (see Form A.20)

11.5 Battery electrolyte
Battery electrolyte leakage presents no

hazard
11.6  F Specially protected equipment (see Form A.20)

11.7 Fluid pressure and leakage

11.7.1 Maximum pressure
Maximum pressure not exceeded
11.7.2 F Leakage and rupture at high pressure (see Form A.21)
Test to IEC 60335 (refrigeration only)
PRESSURE VESSEL meet requirements of
14.101
11.7.3 F Leakage from low-pressure parts (see Form A.21)
11.7.4 Overpressure safety device
a) – Fitted
–Operates ≤ maximum working pressure
b) Pressure not exceeded by more than
10 %
c) No accumulation of fluid in a seating of a
safety value
d) Device is only used to discharge excess
pressure in single fault condition
e) Device construction materials not be
degraded to cause a hazard
Fitted in accordance to with manufacturer’s
instructions
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
11.7.101 Indicator and interlock for residual fluid
Means provided to indicate hazard due to
residual fluid
11.7.102 Discharge to atmosphere
Discharge does not causes a hazard
and
a) Discharge pipe:
– has a continuous fall to ist outlet
or
– specified in manufacturer`s instructions

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Clause Requirement - Test Result Comments Verdict

b) If discharge inside cabinet:

– cabinet vented
– discharge and vent not cause a hazard

11.7.103 Hot and cold water services

Conformity with IEC 61770
Manufacturer's instructions on back-
syphonage prevention
11.101 Instruments and indicating devices

Indication provided if necessary for safety:
a) Water pump pressure
b) PRESSURE VESSEL pressure
c) Vapour condenser temperature
d) Non-resettable OPERATING CYCLE counter
e) Stages of the OPERATING CYCLE
f) Failure of supplies
11.102 Interruption of non-electrical supplies and
services
Any electrical or non-electrical safety
system not disabled
F No hazard (see Form A.1)
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 2
(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)
Maximum sound pressure level does not
exceed the mean level by more than 15 dB

12.5.2 F Ultrasonic pressure (see Form A.23)
12.6 Laser sources (IEC 60825)
13 Protection against liberated gases,
explosion and implosion and pathogenic
substances
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

TR 61010-3-045  IEC:2003(E) – 27 –

Clause Requirement - Test Result Comments Verdict

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
F – single component cannot cause hazard (see Form A.24, including circuit
(short-circuit and open circuit) diagram)
– 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 LOAD access after a fault
Access to LOAD prevented while the
CHAMBER conditions present a hazard
Additional instructions provided to facilitate
entry under hazardous conditions
13.102 Chemical dosing system
Means provided to replenish containers
without creating a hazard
13.103 Pathogenic substances
Emissions do not cause a hazard
Additional instructions provided if additional
means required to control emissions

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)
Any device failure indicated by a visible
alarm
Starting of operating cycle prevented while
a hazardous component failure exists
Access to load prevented until hazard is
removed
14.2 Motors
14.2.1 F Motor temperatures (see Form A.25)
14.2.2 Series excitation motors
14.3 Overtemperature protection devices

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Clause Requirement - Test Result Comments Verdict

F Devices operating in a SINGLE FAULT (see Form A.26)
CONDITION
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
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
F Transformers meet 4.4.4.1 to 4.4.4.3. (see Form A.27)
14.7.2 Overload tests
Transformer:
– has overtemperature protection meeting
14.3
or
F – meets 4.4.4.1 to 4.4.4.3 (see Form A.28)
14.8 Overpressure safety devices
Meets ISO 4126, except for small pressure
systems outside the scope
14.101 PRESSURE VESSELS
Demonstrated compliance with applicable
national pressure vessel regulations and
codes
or
Manufacturer’s documentation states
regulations and codes which pressure
vessel complies with
14.102 Visibility and readability of instruments and
indicating devices
Safety related indicating devices:
Readily seen
Readable at 1 m with 215 lx ± 15 lx, except
operating cycle counters
14.103 Control system
Operator cannot set to hazardous condition
Automatic controller provided with system
to control access to system functions

TR 61010-3-045  IEC:2003(E) – 29 –

Clause Requirement - Test Result Comments Verdict

The following functions are protected by
increasingly severe constrains:

a) Initiating of operating cycle

b) Selection of particular operating cycle

c) Manual advance through operating cycle

d) Changing programme
e) Maintenance
Termination of operating cycle does not

require tool, key or code
Disabling of safety devices prevented
Selection of manual mode disables
automatic controller
14.104 Microprocessors
Failure does not cause a hazard
Loss of processor memory battery power
does not lead to a hazard
14.105 Access ports
Means are provided to prevent hazardous
opening of ports which can be
opened/closed without TOOL
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
15.101 Doors
a) Means are provided to prevent
hazardous process material being admitted
to CHAMBER before closing/locking/sealing
the DOOR
b) Means are provided to prevent new
OPERATING CYCLE starting:
1) After failure of the DOOR
2) After failure of the LOAD transport system
3) From conditions within the CHAMBER

15.102 Double-ended equipment
Opening or closing a DOOR at the end of the
CHAMBER remote from OPERATOR prevented
or
Automat
...