IEC TR 61010-3-045:2003
(Main)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
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
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 EC 61010-1: 1990 + amendment 1:1992 + amendment 2:1995
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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
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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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
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
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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
...








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