IEC TR 61010-3-043:2001

Safety requirements for electrical equipment for measurement, control and laboratory use - Part 3-043: Conformity verification report for IEC 61010-2-043:1997 - Particular requirements for dry heat sterilizers using either hot air or hot inert gas for treatment of medical materials and for laboratory processes

A technical report for use by test houses and other users. It assists them with determining and recording verification of conformity of the equipment under test with the requirements of IEC61010-2-043 (1997). If the paper version of the report is ordered, a diskette is provided with fill-in tables for recording the test results. If the report is downloaded directly from the web, it consists of two files: the technical report as a ZIP file and the fill-in tables as a revisable file.

General Information

• Status: Withdrawn
• Publication Date: 21-Aug-2001
• Withdrawal Date: 30-Mar-2008
• ICS: 11.080.10 - Sterilizing equipment
• ICS: 19.080 - Electrical and electronic testing
• Technical Committee: TC 66 - Safety of measuring, control and laboratory equipment
• Drafting Committee: WG 11 - TC 66/WG 11
• Current Stage: WPUB - Publication withdrawn
• Completion Date: 31-Mar-2008

Standards Content (Sample)

TECHNICAL IEC
REPORT
TR 61010-3-043
First edition
2001-08
Safety requirements for electrical equipment
for measurement, control, and laboratory use –
Part 3-043:
Conformity verification report for
IEC 61010-2-043:1997 –
Particular requirements for dry heat sterilizers
using either hot air or hot inert gas for treatment
of medical materials and for
laboratory processes
Règles de sécurité pour appareils électriques de mesurage,
de régulation et de laboratoire –
Partie 3-043:
Rapport de vérification de la conformité de
la CEI 61010-2-043:1997 –
Prescriptions particulières pour les stérilisateurs à chaleur
utilisant de l'air chaud ou un gaz inerte chaud pour
le traitement des matériels à usage médical et durant
les procédés de traitement de laboratoire

Reference number
IEC/TR 61010-3-043:2001(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.

Consolidated editions
The IEC is now publishing consolidated versions of its publications. For example,

edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the base publication, the

base publication incorporating amendment 1 and the base publication incorporating
amendments 1 and 2.
Further information on IEC publications
The technical content of IEC publications is kept under constant review by the IEC,
thus ensuring that the content reflects current technology. Information relating to
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TECHNICAL IEC
REPORT
TR 61010-3-043
First edition
2001-07
Safety requirements for electrical equipment
for measurement, control, and laboratory use –
Part 3-043:
Conformity verification report for
IEC 61010-2-043:1997 –
Particular requirements for dry heat sterilizers
using either hot air or hot inert gas for treatment
of medical materials and for
laboratory processes
Règles de sécurité pour appareils électriques de mesurage,
de régulation et de laboratoire –
Partie 3-043:
Rapport de vérificatoin de la conformité de
la CEI 61010-2-043:1997 –
Prescriptions particulières pour les stérilisateurs à chaleur
utilisant de l'air chaud ou un gaz inerte chaud pour
le traitement des matériels à usage médical et durant
les procédés de traitement de laboratoire

 IEC 2001  Copyright - all rights reserved
No part of this publication may be reproduced or utilized in any form or by any means, electronic or
mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: [phone] e-mail: [e-mail] IEC web site http://www.iec.ch
Commission Electrotechnique Internationale
PRICE CODE
XA
International Electrotechnical Commission
For price, see current catalogue

– 2 – TR 61010-3-043  IEC:2001(E)

CONTENTS
FOREWORD . 3

Conformity verification report IEC 61010-2-043. 5

5 Marking and documentation .10

6 Protection against electric shock .14

7 Protection against mechanical hazards.21

8 Mechanical resistance to shock and impact .23

9 Equipment temperature limits and protection against the spread of fire .23
10 Resistance to heat .24
11 Protection against hazards from fluids .25
12 Protection against radiation, including laser sources, and against sonic
and ultrasonic pressure.26
13 Protection against liberated gases, explosion and implosion .26
14 Components .27
15 Protection by interlocks .29
16 Measuring circuits .29
Annex K…………. .30
Table 1 – Documents attached to this report . 7
Table 2 – Test equipment list. 8
Table 3 – List of components relied on for safety . 9
Form A.1 to Form A.29 .30 to 59

TR 61010-3-043  IEC:2001(E) – 3 –

INTERNATIONAL ELECTROTECHNICAL COMMISSION

___________
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT

FOR MEASUREMENT, CONTROL, AND LABORATORY USE –

Part 3-043: Conformity verification report for IEC 61010-2-043:1997–

Particular requirements for dry heat sterilizers using either hot air

or hot inert gas for treatment of medical materials

and for laboratory processes
FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of the IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, the IEC publishes International Standards. Their preparation is
entrusted to technical committees; any IEC National Committee interested in the subject dealt with may
participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. The IEC collaborates closely with the International Organization
for Standardization (ISO) in accordance with conditions determined by agreement between the two
organizations.
2) The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, an
international consensus of opinion on the relevant subjects since each technical committee has representation
from all interested National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical specifications, technical reports or guides and they are accepted by the National
Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
The main task of IEC technical committees is to prepare International Standards. However, a
technical committee may propose the publication of a technical report when it has collected
data of a different kind from that which is normally published as an International Standard, for
example “state of the art”.
Technical reports do not necessarily have to be reviewed until the data they provide are
considered to be no longer valid or useful.
IEC 61010-3-043, which is a technical report, has been prepared by IEC technical com-
mittee 66: Safety of measuring, control, and laboratory equipment.
The text of this technical report is based on the following documents:
Committee draft Report on voting
66/223/CDV 66/230/RVC
Full information on the voting for the approval of this technical report can be found in the report
on voting indicated in the above table.

– 4 – TR 61010-3-043  IEC:2001(E)

This publication has been drafted in accordance with the ISO/IEC Directives, Part 3.

This report is a Technical Report and is of a purely informative nature and is therefore by itself
not to be regarded as an International Standard. It is for use by test houses and other users to
assist them with determining and recording verification of conformity of the equipment under

test with the requirements of:

IEC 61010-2-043: 1997
and
IEC 61010-1:1990 + amendment 1:1992 + amendment 2:1995
The protocol for completion of this report is contained in publication IEC 61010-3:1997.
The IEC sells read-only PDF files as a general rule. In the present instance, and quite
exceptionally, to enable the user to fill in the forms, a revisable file is included in a pocket
affixed to the back cover of this publication.
This file can also be downloaded from the Web as a PDF file. There is, however, at the end of
the document, a revisable file containing the forms. Please use the zip/unzip function.
A bilingual version will not be issued.
A French version may be issued.
The committee has decided that the contents of this publication will remain unchanged
until 2004. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
TR 61010-3-043  IEC:2001(E) – 5 –

Conformity Verification Report

IEC 61010-2-043
Safety requirements for electrical equipment for measurement, control, and laboratory use –

Part 2-043: Particular requirements for dry heat sterilizers

using either hot air or hot inert gas for treatment of

medical materials, and for laboratory processes

Report reference No.:

Compiled by (+ signature).:

Approved by (+ signature).:
Date of issue.:
Testing organization.:
Address.:
Testing location .:
Applicant.:
Address.:
Standard.: IEC 61010-2-043:1997
and
IEC 61010-1:1990 + amendment 1:1992 + amendment 2:1995
Copyright blank test report.: This report has been prepared by IEC/TC 66, which retains
responsibility for any changes or corrections required.
Test procedure.:
Procedure deviation.:

Non-standard test method.:
Type of item tested.:     Laboratory
Trademark. .:
Model/type reference.:
Manufacturer.:
Rating.:
Copy of rating plate:
– 6 – TR 61010-3-043  IEC:2001(E)

Description of equipment function.:

INSTALLATION/OVERVOLTAGE CATEGORY:

OLLUTION DEGREE
P :
Environmental rating:  Standard  Other (specify):

Equipment mobility: Portable Hand-held  Floorstanding  Fixed
 Built in Benchmounted Other (specify):
Connection to mains supply:  Permanent Detachable   Non-detachable  None
Operating conditions: Continuous Short-time  Intermittent
Overall size of the equipment (Length x Width x Height):
Mass of the equipment (kg):
Marked degree of protection to IEC 60529:  IP___  ___
Accessories and detachable parts included in the evaluation:
Options:
NOTE  "(see form A.X)" refers to a form appended to the report.

TR 61010-3-043  IEC:2001(E) – 7 –

Table 1 – Documents attached to this report

Document No Document description Number of pages

– 8 – TR 61010-3-043  IEC:2001(E)

Table 2 – Test equipment list
Item Type Equipment Calibration date Comments

1)
No. Last Due
1)
or interval between calibrations.

TR 61010-3-043  IEC:2001(E)             – 9 –

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

– 10 – TR 61010-3-043  IEC:2001(E)

Clause Requirement Result Comments

Subclause
5 Marking and doc
...