IEC TR 61010-3-101:2003

TECHNICAL IEC
REPORT
TR 61010-3-101
First edition
2003-04
Safety requirements for electrical equipment
for measurement, control, and laboratory use –
Part 3-101:
Conformity verification report for
IEC 61010-2-101:2002 –
Particular requirements for in vitro
diagnostic (IVD) medical equipment
Règles de sécurité pour appareils électriques
de mesurage, de régulation et de laboratoire –
Partie 3-101:
Rapport de vérification de la conformité
de la CEI 61010-2-101:2002 –
Prescriptions particulières pour appareils médicaux
de diagnostic in vitro (DIV)
Reference number
IEC/TR 61010-3-101:2003(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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TECHNICAL IEC
REPORT
TR 61010-3-101
First edition
2003-04
Safety requirements for electrical equipment
for measurement, control, and laboratory use –
Part 3-101:
Conformity verification report for
IEC 61010-2-101:2002 –
Particular requirements for in vitro
diagnostic (IVD) medical equipment
Règles de sécurité pour appareils électriques
de mesurage, de régulation et de laboratoire –
Partie 3-101:
Rapport de vérification de la conformité
de la CEI 61010-2-101:2002 –
Prescriptions particulières pour appareils médicaux
de diagnostic in vitro (DIV)
 IEC 2003  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, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: +41 22 919 02 11 Telefax: +41 22 919 03 00 E-mail: inmail@iec.ch  Web: www.iec.ch
PRICE CODE
Commission Electrotechnique Internationale
XB
International Electrotechnical Commission
Международная Электротехническая Комиссия
For price, see current catalogue

– 2 – TR 61010-3-101  IEC:2003(E)

CONTENTS
FOREWORD . 3

Conformity verification report for IEC 61010-2-101:2002 . 5

5 Marking and documentation .11

6 Protection against electric shock.15

7 Protection against mechanical HAZARDS .21

8 Mechanical resistance to shock and impact.21

9 Protection against the spread of fire.22
10 Equipment temperature limits and resistance to heat .23
11 Protection against HAZARDS from fluids.24
12 Protection against radiation, including laser sources, and against sonic
and ultrasonic pressure.25
13 Protection against liberated gases, explosion and implosion .25
14 Components.26
15 Protection by interlocks.27
16 Test and measurement equipment .27
Annex F – Routine tests .27
Annex AA – RISK management. .27
Annex BB – Instructions for use for self-test IVD medical equipment.27
Annex XX – List of applicable and omitted clauses/subclauses and associated forms in
the test report. . 62
Annex YY – Details of the changes included in the combined CVR for
TR IEC 61010-3-101:2003, to reflect the specific requirements of
IEC 61010-2-101:2002 .67
Table 1 – Documents reviewed . 8
Table 2 – Test equipment list . 9
Table 3 – List of components and circuits relied on for safety.10
Form A.1 to Form 33 .28 to 61

TR 61010-3-101  IEC:2003(E) – 3 –

INTERNATIONAL ELECTROTECHNICAL COMMISSION

___________
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT

FOR MEASUREMENT, CONTROL, AND LABORATORY USE –

Part 3-101: Conformity verification report for IEC 61010-2-101:2002

Particular requirements for in vitro

diagnostic (IVD) medical equipment

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”.
IEC 61010-3-101, 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
66/279/DTR 66/317/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 IEC/ISO Directives, Part 2.

– 4 – TR 61010-3-101  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 to assist users of the standard with

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

requirements of:
IEC 61010-2-101: 2002
The protocol for completion of this report is contained in publication IEC 61010-3:2003.

The IEC sells read-only PDF files as a general rule. In the present instance, and quite

exceptionally, to enable the user to fill in the forms, a revisable file is included in a pocket

affixed to the back cover of this publication.
This file can also be downloaded from the Web as a PDF file. There is, however, at the end
of the document, a revisable file containing the forms. Please use the zip/unzip function.
WARNING – Experience has shown that if a version is downloaded in Word 97or Word 2000
and is subsequently converted to Word 6, some of the symbols may have been incorrectly
changed in the conversion. Care must, therefore, be taken to verify the symbols used in the
converted document.
The committee has decided that the contents of this publication will remain unchanged until
2008. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
TR 61010-3-101  IEC:2003(E) – 5 –

TEST REPORT
IEC 61010-2-101
Safety requirements for electrical equipment for measurement,

control, and laboratory use
Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipmemnt

Report Reference No. :

Tested by (name and signature) . :
Approved by (name and signature)
.................................................. :
Date of issue. :
Contents . : Pages
Testing organisation. :
Address. :
Testing location. :
Applicant’s name . :
Address. :
Test specification:
Standard . : IEC 61010–2–101 : 2002 /
and
nd
IEC 61010 – 1: 2001 (2 Edition)
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.:
Test item description . :
Trademark. :
Model/Type reference . :
Rating(s) . :

– 6 – TR 61010-3-101  IEC:2003(E)

Test item particulars. :

Type of item tested .: Measurement / Control / Laboratory

Description of equipment function. :

INSTALLATION/OVERVOLTAGE CATEGORY. :

POLLUTION DEGREE . :

Environmental rating. : standard / extended (specify):

Equipment mobility. : portable / hand-held / floorstanding / fixed / built in/

benchmounted/other (specify):
Connection to mains supply. :
Permanent / detachable cord set /
non detachable cord set / none
Operating conditions. :
continuous / short-time / intermittent
Overall size of the equipment (L x W x H) . :
Mass of the equipment (kg) . :
Marked degree of protection to IEC 60529. : IP_____  _____
Accessories and detachable parts included in the
evaluation. :
Options included . :
Test case verdicts:
Test case does not apply to the test object.: N/A
Test object does meet the requirement.: P(Pass)
Test object does not meet the requirement .: F(Fail)
General remarks:
The test results presented in this report relate only to the item(s) tested.
"(see remark #)" refers to a remark appended to the report.
"(see Annex #)" refers to an annex appended to the report.
"(see Form A.#)" refers to a table appended to the report.
Throughout this report a comma (point) is used as the decimal separator.

TR 61010-3-101  IEC:2003(E) – 7 –

Copy of equipment markings :
Summary of test results (information/comments):

– 8 – TR 61010-3-101  IEC:2003(E)

TABLE: 1 - Documents reviewed
Document Version Date Editor Attached Page

Name Numbers
Yes / No
TR 61010-3-101  IEC:2003(E) – 9 –

TABLE: 2 - Test equipment list

Calibration date
Test Type Unique Ranges Comments

equipment and identification used

number make number Last Due
note 2
note 1
Note 1 Or interval between calibrations
Note 2 Range used may by noted using the Instrument Code on the specific Form

– 10 –          TR 61010-3-101 � IEC:2003(E)

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NOTE 1 - List all manufacturers concerned.
NOTE 2 - Electrical, mechanical, flammability, etc.
NOTE 3 - Licence number, file number or other documentary evidence of acceptance

TR 61010-3-101  IEC:2003(E) – 11 –

Clause Requirement – Test Result - Remarks Verdict

5 MARKING AND DOCUMENTATION
5.1.1 General
Required equipment markings are:

visible:
From the exterior; or
After removing a cover; or
Opening a door
After removal from a rack or panel
Not put on parts which can be removed by an OPERATOR
Letter symbols (IEC 60027) used
Additional symbols cannot be confused with the
international ones.
5.1.2 Identification
Equipment is identified by:
5.1.2a) Manufacturer’s name or trademark and address
5.1.2b) Model number, name or other means
5.1.2c) The name and address of the authorized representative of
the manufacturer
The equipment or packaging or the instructions for use —
include:
1) The serial-number or the batch code preceded by
„LOT“ symbol 102 of Table 1
2 i) Indication that the equipment is IVD medical equipment
2 ii) Indication that the equipment is self-test IVD medical
equipment
2 iii) Identification of detachable components
2 iv) Expiry date of consumable parts
5.1.3 Mains supply
Equipment is marked as follows:
5.1.3a) Nature of supply:
1) A.C. RATED mains frequency or range . of frequencies

................................................................................. :
2) D.C. with symbol 1
5.1.3b) RATED supply voltage(s) or range. :
5.1.3c) Max. RATED power (W or VA)or input current. :
The measured value not more than 110 % (See Form A.3)
If more than one voltage range:
Separate values marked; or
Values differ by less than 20 % (See Form A.3)
5.1.3d) 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

– 12 – TR 61010-3-101  IEC:2003(E)

Clause Requirement – Test Result - Remarks Verdict

5.1.3e) 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; or

Symbol 14 with full details in the documentation

5.1.4 Fuses
OPERATOR replaceable fuse marking
(see also 5.4.5) . :
5.1.5 TERMINALS, connections and operating devices
Where necessary for safety, indication of purpose of
TERMINALS, connectors, controls and indicators marked
If insufficient space, symbol 14 used
5.1.5.1 TERMINALS
Mains supply TERMINALS identified
Other TERMINAL marking . :
5.1.5.1a) FUNCTIONAL EARTH TERMINALS (symbol 5 used)
5.1.5.1b) PROTECTIVE CONDUCTOR TERMINALS:
Symbol 6 is placed close to or on the TERMINAL; or
Part of appliance inlet
5.1.5.1c) TERMINALS of measuring and control circuits (symbol 7
used)
5.1.5.1d) HAZARDOUS LIVE TERMINALS supplied from the interior
Standard MAINS socket outlet; or
RATINGS marked; or
Symbol 14 used
5.1.5.1e) ACCESSIBLE FUNCTIONAL EARTH TERMINALS:
Self-evident; or
Indication (symbol 8 acceptable)
5.1.5.2 Measuring circuit TERMINALS
For TERMINALS other than those permanently connected and

not ACCESSIBLE:
RATED voltage or current marked
Unless clear indication that below limits:
Maximum RATED voltage to earth is marked; or
For specific connection to other equipment TERMINALS only, and
means for identifying provided
Appropriate measurement category marked
(CAT II, CAT III or CAT IV); or
No measurement category marked (CAT I)
Required markings are adjacent to TERMINALS; OR
If insufficient space:
On the RATING plate or scale plate; or
TERMINAL is marked with symbol 14

TR 61010-3-101  IEC:2003(E) – 13 –

Clause Requirement – Test Result - Remarks Verdict

5.1.6 Switches and circuit breakers

If disconnecting device, on or off position marked

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 Field-wiring TERMINAL boxes

(See 10.3a))
If TERMINAL or ENCLOSURE exceeds 60 °C:

Cable temperature RATING marked
Marking visible or beside TERMINAL
5.1.101 Transport and storage
Packaging labelled to indicate special conditions for
transport or storage
5.2 Warning markings
Visible when ready for NORMAL USE
Are near or on applicable parts
Symbols and text correct dimensions and colour
If necessary marked with symbol 14
Statement to isolate or disconnect
Potentially infectious equipment marked with symbol 101
Equipment that can be hazardous due to the use of chemical
substances marked with the appropriate symbol
Containers or bags for biohazardous waste material which can be
removed from the equipment during NORMAL USE marked with
symbol 101
5.3 Durability of markings
The required markings resist the effects of temperature and (See Form A.4)
rubbing, and of solvent and reagents likely to be
encountered in NORMAL USE
5.4 Documentation
5.4.1 General
Equipment is accompanied by documentation which (For documents see Table 1)
includes:
5.4.1a) Intended use
5.4.1b) Technical specification
5.4.1c) Instructions for use
5.4.1d) Name and address of manufacturer or supplier
5.4.1e) Information specified in 5.4.2 to 5.4.5
5.4.1f) If marking of TERMINALS required, definition of measurement
category
5.4.1g) If CAT 1:
Warning
RATINGS
Warning statements and a clear explanation of warning
symbols:
Provided in the documentation; or
Information is marked on the equipment

– 14 – TR 61010-3-101  IEC:2003(E)

Clause Requirement – Test Result - Remarks Verdict

Information about any RISKS not reduced to a TOLERABLE RISK

level
Information included in documentation on:

Training; or
Protective devices; or
Personal protective equipment to reduce RISKS to a
TOLERABLE RISK level specified;

5.4.2 Equipment RATINGS
Documentation includes:
5.4.2a) Supply voltage or voltage range
Frequency or frequency range
Power or current RATING
5.4.2b) Description of all input and output connections
5.4.2c) RATING of insulation of external circuits,
when such circuits are nowhere ACCESSIBLE
5.4.2d) Statement of the range of environmental conditions
5.4.2e) Degree of protection (IEC 60529)
5.4.3 Equipment transportation, installation and assembly —
instructions
Documentation for the RESPONSIBLE BODY includes : —
5.4.3a) Instructions for transportation after delivery to the RESPONSIBLE
BODY
5.4.3b) Floor loading requirements
5.4.3c) Individual weights of principal heavy subassemblies
5.4.3d) Location and mounting instructions
5.4.3e) Assembly instructions
5.4.3f) Instructions for protective earthing
5.4.3g) The sound data required by 12.5.1
5.4.3h) Instructions relating to handling, containment and exhaust of
hazardous substances
5.4.3I) Any drainage systems required
5.4.3j) Protective measures relating to hazardous radiation

5.4.3k) Connections to the supply
5.4.3l) PERMANENTLY CONNECTED EQUIPMENT only: —
1) Mains supply requirements and details of connections
2) If external switch or circuit-breaker, requirements and location
recommendation
5.4.3m) Special services including pressure limits
5.4.4 Equipment operation
Instructions for use include:
5.4.4a) Details of operating controls
5.4.4b) Positioning for disconnection
5.4.4c) Interconnection
5.4.4d) Specification of intermittent operation limits
5.4.4e) Explanation of symbols used

TR 61010-3-101  IEC:2003(E) – 15 –

Clause Requirement – Test Result - Remarks Verdict

5.4.4f) Any actions by an OPERATOR in case of a malfunction

5.4.4g) Cleaning and decontamination (see 11.2) incl. materials

5. 4.4h) Disposal of waste
5.4.4i) Hazardous substances,use, need for training,or personal
protection measures
5.4.4j) Infectious substances, need to use protective gloves or
other protective means
5.4.4k) Hazardous vapours, instructions for protection of the
mouth, nose or eyes
5.4.4l)
Hazardous radiation, instructions and requirements for
protective devices
5.4.4m) A statement about protection impairment if used in a
manner not specified by the manufacturer
5.4.4.101 Self-test IVD medical equipment
Instructions for use for self-test equipment comply with
annex BB
5.4.5 Equipment maintenance
Instructions include:
Sufficient preventive maintenance and inspection information
Replacement of hoses, etc.
Specific battery type
Any manufacturer specified parts
RATING and characteristics of fuses
5.4.101 Removal of equipment from use for repair or disposal
—
Instructions for the RESPONSIBLE BODY for eliminating or
reducing HAZARDS provided
5.4.102 Transport and storage
—
Permissible environmental conditions for transport and
storage specified:
In documentation; and
On outside of packaging
6 PROTECTION AGAINST ELECTRIC SHOCK (See Form A.5)
6.1 General
6.1.1 Requirements
ACCESSIBLE parts not HAZADOUS LIVE in NORMAL CONDITION
and SINGLE FAULT CONDITION
Conformity is checked by the determination of 6.2 and 6.3
followed by the tests of 6.4 to 6.11
6.1.2 Exceptions
Capacitance test (See Forms A.6 and A.7)
Parts not HAZARDOUS LIVE 10 s after interruption of supply
6.2 Determination of ACCESSIBLE parts
(See Form A.6)
6.2.1 General examination
6.2.2 Openings above parts that are HAZARDOUS LIVE
6.2.3 Openings for pre-set controls
6.3 Permissible limits for ACCESSIBLE parts
6.3.1 Values in NORMAL CONDITION (See Form A.7)

– 16 – TR 61010-3-101  IEC:2003(E)

Clause Requirement – Test Result - Remarks Verdict

6.3.2 Values in SINGLE FAULT CONDITION (See Form A.8)

6.4 Protection in NORMAL CONDITION

(see 6.2, 6.3.1, 6.7, 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 (6.5.4)

6.5.1 Protective BONDING
ACCESSIBLE conductive parts:
Separated by DOUBLE INSULATION or REINFORCED INSULATION; or
Bonded to the PROTECTIVE CONDUCTOR TERMINAL; or
Separated by screen or BARRIER bonded to PROTECTIVE
CONDUCTOR TERMINAL from parts which are HAZARDOUS LIVE
6.5.1.1 Integrity of PROTECTIVE BONDING
6.5.1.1a) PROTECTIVE BONDING consists of directly connected
structural parts or discrete conductors or both; and
withstands thermal and dynamic stresses
6.5.1.1b) Soldered connections:
Independently secured
Not used for other purposes
Screw connections are secured
6.5.1.1c) PROTECTIVE BONDING not interrupted
6.5.1.1d) Any moveable connection specifically designed, and meets
6.5.1.3
6.5.1.1e) No external metal braid of cables used
6.5.1.1f) If MAINS supply passes through:
Means provided for passing protective conductor;
Impedance meets 6.5.1.3.
6.5.1.1g) Protective conductors bare or insulated,
if insulated, green/yellow
Exceptions:
1) earthing braids;
2) internal protective conductors etc.;

Green/yellow not used for other purposes
6.5.1.1h) TERMINAL suitable, and meets 6.5.1.2
6.5.1.2 PROTECTIVE CONDUCTOR TERMINAL
6.5.1.2a) Contact surfaces are metal
6.5.1.2b) Appliance inlet used
6.5.1.2c) For rewireable cords and PERMANENTLY CONNECTED
EQUIPMENT, PROTECTIVE CONDUCTOR TERMINAL is close to
MAINS supply TERMINALS
6.5.1.2d) 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
6.5.1.2e) Equivalent current-carrying capacity to MAINS supply
TERMINALS
TR 61010-3-101  IEC:2003(E) – 17 –

Clause Requirement – Test Result - Remarks Verdict

6.5.1.2f) If plug-in, makes first and breaks last

6.5.1.2g) If also used for other bonding purposes, protective

conductor:
Applied first;
Secured independently;
Unlikely to be removed by servicing; or

Warning marking requires replacement of protective

conductor
6.5.1.2h) Protective conductor of measuring circuit:
1) Current RATING;
2) PROTECTIVE BONDING:
Not interrupted; or
Indirect bonding used (see 6.5.1.5)
6.5.1.2i) FUNCTIONAL EARTH TERMINALS allow independent connection
6.5.1.2j) If a binding screw:
Suitable size for bond wire
Not smaller than M 4 (No. 6)
At least 3 turns of screw engaged
Contact pressure not capable of reduction by deformation
of materials
Passes tightening torque test (See Form A.9)
6.5.1.3 Impedance of PROTECTIVE BONDING of plug-connected (See Form A.10)
equipment
6.5.1.4 Bonding impedance of PERMANENTLY CONNECTED (See Form A.10)
EQUIPMENT
6.5.1.5 Indirect bonding for measuring and test equipment (See Form A.11)
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.12)
6.5.3a) HIGH-INTEGRITY single component used (s. 14.6); or
6.5.3b) A combination of components used; or
6.5.3c) A combination of BASIC INSULATION and current- or voltage-
limiting device used
Components, wires and connections are RATED as required
6.5.4 Automatic disconnection of the supply
If used, it meets :
6.5.4a) Supplied with the equipment; or
Specified by installation instruction
6.5.4b) RATED disconnecting time within limit specified
6.5.4c) RATED for maximum RATED LOAD
6.6 Connections to external circuits
6.6.1 General
Connections do not cause ACCESSIBLE parts of the following
to become HAZARDOUS LIVE in NORMAL CONDITION or SINGLE
FAULT CONDITION:
6.6.1a) The external circuits
– 18 – TR 61010-3-101  IEC:2003(E)

Clause Requirement – Test Result - Remarks Verdict

6.6.1b) The equipment
Separation of circuits provided; or

Short circuit of separation does not cause a HAZARD

Instructions or markings include: —

1) RATED conditions for TERMINAL

2) Required RATING of external circuit insulation

6. 6.2 TERMINALS for external circuits

TERMINALS which receive a charge from an internal (See Form A.7)
capacitor are not HAZARDOUS LIVE
High voltage TERMINALS energized from the interior are:
Not ACCESSIBLE or
When unmated, no HAZARDOUS LIVE voltage; or
marked with symbol 12
6.6.3 Circuits with TERMINALS which are HAZARDOUS LIVE
These circuits are:
Not connected to ACCESSIBLE conductive parts; or
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
6.6.4 ACCESSIBLE TERMINALS for stranded conductors
6.6.4a) No risk of accidental contact because:
Located or shielded
Self-evident or marked whether connected to ACCESSIBLE
conductive parts
6.6.4b) ACCESSIBLE TERMINALS will not work loose
6.7 CLEARANCES and CREEPAGE DISTANCES (See Form A.5 and A.13)
6.8 Procedure for dielectric strength tests
(See Form A.5 and A.14)
6.9
Constructional requirements for protection
against electric shock
6.9.1 General
If a failure could cause a HAZARD:
6.9.1a) Security of wiring connections

6.9.1b)
Screws securing removable covers
6.9.1c) Accidental loosening
Easily damaged materials not used
Non-impregnated hydroscopic materials not used
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:
6.9.2a)
An insulating coating or BARRIER on the inside; or
6.9.2b)
CLEARANCES and CREEPAGE DISTANCES cannot be reduced by
loosening of parts or wires
TR 61010-3-101  IEC:2003(E) – 19 –

Clause Requirement – Test Result - Remarks Verdict

6.9.3 Over-range indication
Unambiguous
6. 10 Connection to MAINS supply source and connections
between parts of equipment
6.10.1 MAINS supply cords
6.10.1a) RATED for maximum equipment current (see 5.1.3c)

Cable complies with IEC 60227 or IEC 60245 or is a certified cord

6.10.1b) Heat-resistant if likely to contact hot parts

6.10.1c) Temperature RATING (cord and inlet)
6.10.1d) Green/yellow used only for connection to PROTECTIVE
CONDUCTOR TERMINALS
Detachable cords with IEC 60320 MAINS connectors:
Conform to IEC 60799; or
Have the current RATING of the MAINS connector
6.10.2 Fitting of non-detachable MAINS supply cords
Non-detachable cord protection:
6.10.2a) Inlet or bushing smoothly rounded; or
6.10.2b) Insulated cord guard protruding ≥ 5D
The protective earth conductor is the last to take the strain
6.10.2 Cord anchorages:
6.10.2a) Cord is not clamped by direct pressure from a screw
6.10.2b) Knots are not used
6.10.2c) Cannot push the cord into the equipment to cause a HAZARD
6.10.2d) No failure of cord insulation in anchorage with metal parts
6.10.2e) Compression bushing:
Clamps all types and sizes of MAINS cords; and Is suitable for
connection to TERMINALS provided; or
:
It is designed for a specified screened MAINS cord
6.10.2f) Cord replacement does not cause a HAZARD and method of strain
relief is clear
Push-pull test (See Form A.16)

6.10.3 Plugs and connectors
6.10.3a) MAINS supply plugs, connectors etc., conform with relevant
specifications
6.10.3b) If equipment supplied at voltages below 6.3.2.a) or from a sole
source:
Plugs of supply cords do not fit MAINS sockets above RATED supply
voltage
MAINS-type plugs used only for connection to MAINS supply
6.10.3c) Plug pins which receive a charge from an internal capacitor (See Form A.7)
6.10.3d)
Accessory MAINS socket outlets:
1) Marking if accepts a standard MAINS plug
(see 5.1.3e)
2) Input has a protective earth conductor if outlet has earth
TERMINAL contact
– 20 – TR 61010-3-101  IEC:2003(E)

Clause Requirement – Test Result - Remarks Verdict

6.11 Disconnection from supply source

6.11.1 General (see 6.11.1.1 to 6.11.2.6)

Disconnects all current carrying conductors

6.11.1.1 Exceptions
6.11.1.1a)
Equipment supplied by low energy source; or

6.11.1.1b)
Equipment connected to impedance protected supply; or

6.11.1.1c) Equipment constitutes an impedance protected load

6.11.2 Requirements according to type of equipment
6.11.2.1 PERMANENTLY CONNECTED EQUIPMENT and multi-phase
equipment
Employs switch or circuit-breaker
If switch or circuit-breaker is not part of the equipment,
documentation specifies:
6.11.2.1a)
Switch or circuit-breaker to be included in building
installation
6.11.2.1b) Location
6.11.2.1c) Marking
6.11.2.2 Single-phase cord-connected equipment
Equipment is provided with:
6.11.2.2a)
Switch or circuit-breaker; or
6.11.2.2b)
Appliance coupler (disconnectable without TOOL); or
6.11.2.2c) Separable plug (without locking device)
6.11.2.3 HAZARDS arising from function
Emergency switch
Emergency switch ≤ 1 m from the moving part
6.11.3 Disconnecting devices
Electrically close to the supply
6.11.3.1 Switches and circuit-breakers
When used as disconnection device:
Meets IEC 60947-1 and IEC 60947-3
Marked to indicate function
Not incorporated in MAINS cord
Does not interrupt protective earth conductor
If has other contacts meets separation requirements of 6.6
and 6.7
6.11.3.2 Appliance couplers and plugs
Where an appliance coupler or separable plug is used as
the disconnecting device (see 6.11.2.2):
Readily identifiable and easily reached by the OPERATOR
Single-phase PORTABLE EQUIPMENT cord
length ≤ 3 m
Protective earth conductor connected first and
disconnected last
TR 61010-3-101  IEC:2003(E) – 21 –

Clause Requirement – Test Result - Remarks Verdict

7 PROTECTION AGAINST MECHANICAL HAZARDS

7.1 General
Conformity is checked by 7.2 to 7.6

7.2 Moving parts
Moving parts not able to crush, etc.

(see also 6.11.2.3)
If OPERATOR access permitted:
a) Access requires TOOL
b) Statement about training
c) Warning markings or symbol 14
7.3 Stability
Marking of non-automatic means
Conformity tests:
7.3a) 10° tilt test
7.3b) multi-directional force test
7.3c) downward force test
7.4 Provisions for lifting and carrying
Handles or grips withstand four times weight
Equipment >18 kg :
Has means for lifting or carrying; or
Directions in documentation
7.5 Wall mounting
Mounting brackets withstand four times weight
7.6 Expelled parts
Equipment contains or limits the energy
Protection not removable without the aid of a TOOL
8 MECHANICAL RESISTANCE TO SHOCK AND IMPACT
After the tests of 8.1 to 8.2:
Voltage tests (See Form A.14)
Inspections:
8a) HAZARDOUS LIVE parts not accessible
8b) ENCLOSURE shows no cracks (HAZARD)
8c) CLEARANCES not less than their permitted values (See Form A.13)
8d) BARRIERS not damaged or loosened
8e) No moving parts exposed, except permitted by 7.2
8f) No damage which could cause spread of fire
8.1 ENCLOSURE rigidity test (See Form A.15)
8.2 Drop test (See Form A.15)
8.101 Transport and storage —
Records of tests performed by the manufacturer show ( See test records attached)
conformity
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Clause Requirement – Test Result - Remarks Verdict

9 PROTECTION AGAINST THE SPREAD OF FIRE

Conformity for each source of HAZARD or area of the (See Form A.17)

equipment is checked by one of the following:

9a) Fault test of 4.4; or (See Forms A.1 and A.2)

9b) Application of 9.1 (eliminating or reducing the sources of

ignition); or
9c) Application of 9.2 (containment of fire within the equipment)

9.1 Eliminating or reducing the sources of ignition within
the equipment
9.1a) 1) Limited-energy circuit (see 9.3); or
2) Insulation meets the requirements for BASIC INSULATION; or (See Form A.5 and A.14)
Bridging the insulation does not cause ignition (See Form A.2)
9.1b) Surface temperature of liquids and parts (see 9.4.a)
9.1c) No ignition in circuits designed to produce heat (See Form A.2)
9.2 Containment of the fire within the equipment, should it
occur
9.2a) Energizing of the equipment is controlled by an OPERATOR
held switch
9.2b) ENCLOSURE conforms with constructional requirements of
9.2.1; and
Requirements of 9.4b) or c) are met
9.2.1 Constructional requirements
9.2.1a) Insulated wires have flammability classification FV1 or (See Table 3 or Form A.18)
better
Connectors and insulating material have flammability (See Table 3 or Form A.18)
classification FV2 or better
9.2.1b) The ENCLOSURE is constructed as follows : (See Form A.17)
1) Bottom constructed with:
No openings; or
Extent as specified in figure 7; or
Baffles as specified in figure 6; or
Perforated as specified in table 12; or
Metal screen with a mesh
2) Sides have no openings as specified in figure 7
3) Material of ENCLOSURE and any baffle or flame BARRIER
is made of………………………….:
Metal (except magnesium); or
Non metallic materials have flammability classification FV1 (See Table 3 or Form A.18)
or better
4) ENCLOSURE and any baffle or flame BARRIER have
adequate rigidity
9.3 Limited-energy circuit
9.3a) Potential not more than 30 r.m.s. and 42.4 V peak, or 60 V
d.c.
9.3b) Current limited by one of following means:
1) Inherently or by impedance; or
2) Overcurrent protective device; or

TR 61010-3-101  IEC:2003(E) – 23 –

Clause Requirement – Test Result - Remarks Verdict

3) A regulating network limits also in SINGLE FAULT

CONDITION
9.3c) Is separated by at least BASIC INSULATION

If Overcurrent protective device used:

Fuse or a non adjustable electromechanical device

9.4 Requirements for equipment containing or using
flammable liquids
Flammable liquids contained in or specified for use with
equipment do not cause spread of fire
Risk is reduced to a tolerable level : (See Form A.20)
9.4a)
The temperature of surface or parts in contact with (See 10.3b))
flammable liquids is 25 °C below fire point
9.4b)
The quantity of liquid is limited
9.4c)
Flames are contained within the equipment
Detailed instructions for risk-reduction provided
9.5 Overcurrent protection
Devices not in the protective conductor
Fuses or single-pole circuit-breakers not fitted
in neutral (multi-phase)
9.5.1 PERMANENTLY CONNECTED EQUIPMENT
Overcurrent device:
Fitted within the equipment; or
Specified in manufacturer's instructions
9.5.2 Other equipment
Protection within the equipment
10 EQUIPMENT TEMPERATURE LIMITS AND RESISTANCE
TO HEAT
10.1 Surface temperature limits for protection against burns
Easily touched surfaces within the limits (See Form A.21A)
Heated surfaces necessary for functional reasons
exceeding specified values:
Are recognizable as such by appearance or function; or
Are marked with symbol 13
Guards are not removable without TOOL
10.2 Temperatures of windings (See Form A.21B)
Limits not exceeded in:
NORMAL CONDITION
SINGLE FAULT CONDITION
10.3 Other temperature measurements (See Form A.21A)
Following measurements conducted if applicable:
10.3a) Value of 60 °C of field-wiring TERMINAL box not exceeded
10.3b) Surface of flammable liquids and parts in contact with this
liquids
10.3c) Surface of non-metallic ENCLOSURES
10.3d) Parts made of insulating material supporting parts
connected to MAINS supply
10.3e) TERMINALS carrying a current more than 0.5 A

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Clause Requirement – Test Result - Remarks Verdict

10.4 Conduct of temperature test

10.5 Resistance to heat
10. 5.1 Integrity of CLEARANCE and CREEPAGE (See Form A.13)
DISTANCES
10.5.2 Non-metallic ENCLOSURES (See Forms A.22)

After treatment:
No HAZARDOUS LIVE parts ACCESSIBLE;

Tests of 8.1 and 8.2 (See Form A.13)

In case of doubt, tests of 6.8 (See Form A.14)
(without humidity preconditioning)
10.5.3 Insulating material
10.5.3a) Parts supporting parts connected to MAINS supply (See 10.3d))
10.5.3b) TERMINALS carrying a current more than 0.5 A (See 10.3e))
In case of doubt, examination of material data
If not conclusive:,
1) Ball pressure test; or (See Form A.23)
2) Vicat softening test of ISO 306 (See Form A.23)
11 PROTECTION AGAINST HAZARDS FROM FLUIDS
11.1 General
11.2 Cleaning (See Form A.24)
11.3 Spillage (See Form A.24)
Potentially aggressive substances (such as corrosive, toxic
or flammable liquids) taken into account
Potentially aggressive substances compatible with
contacted parts of the equipment
11.4 Overflow (See Form A.24)
11.5 Battery electrolyte
Battery electrolyte leakage presents no hazard
11.6 Specially protected equipment (See Form A.24)
11.7 Fluid pressure and leakage
11.7.1 Maximum pressure
Maximum pressure of any part does not exceed P
RATED
11.7.2 Leakage and rupture at high pressure
(See Form A.25)
Test to IEC 60335 (refrigeration only)
11.7.3 Leakage from low-pressure parts (See Form A.25)
11.7.4 Overpressure safety device
Does not operate in NORMAL USE
Meets ISO 4126-1; and
It conforms with:
11.7.4a) Connected as close as possible to parts intended to be protected
11.7.4b) Easy access for inspection, maintenance and repair
11.7.4c) Adjustment only with TOOL
11.7.4d) No discharge towards person
11.7.4e) No HAZARD from deposit of discharged material
11.7.4f) Adequate discharge capacity

TR 61010-3-101  IEC:2003(E) – 25 –

Clause Requirement – Test Result - Remarks Verdict

11.7.4g) No shut-off valve between overpressure safety device and

protected parts
12 PROTECTION AGAINST RADIATION, INCLUDING LASER

SOURCES, AND AGAINST SONIC AND ULTRASONIC
PRESSURE
12.1 General
Equipment provides protection
12.2 Equipment producing ionizing radiation

12.2.1 Ionizing radiation
(See Form A.26)
12.2.2 Accelerated electrons
12.3 Ultra-violet (UV) radiation (Conformity test under
consideration)
12.4 Micro-wave radiation
Power density does not exceed 10 W/m .:
12.5 Sonic and ultrasonic pressure
12.5.1 Sound level (See Form A.27)
12.5.2 Ultrasonic pressure (See Form A.27)
12.6 Laser sources (IEC 60825-1)
13 PROTECTION AGAI
...