SIST EN 60601-2-18:1998
(Main)Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment (IEC 60601-2-18:1996)
Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment (IEC 60601-2-18:1996)
Establishes particular requirements for the safety of endoscopic equipment and enables parts of endoscopic equipment to be tested together or individually.
Medizinische elektrische Geräte - Teil 2: Besondere Festlegungen für die Sicherheit von endoskopischen Geräten (IEC 60601-2-18:1996)
Appareils électromédicaux - Partie 2: Règles particulières de sécurité pour appareils d'endoscopie (CEI 60601-2-18:1996)
Spécifie des prescriptions pour la sécurité des appareils d'endoscopie et permet les essais de leurs composants associés ou considérés individuellement.
Medicinska električna oprema - 2. del: Posebne varnostne zahteve za endoskopsko opremo (IEC 60601-2-18:1996)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 60601-2-18:1998
01-september-1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO 3RVHEQHYDUQRVWQH]DKWHYH]D
HQGRVNRSVNRRSUHPR ,(&
Medical electrical equipment - Part 2: Particular requirements for the safety of
endoscopic equipment (IEC 60601-2-18:1996)
Medizinische elektrische Geräte - Teil 2: Besondere Festlegungen für die Sicherheit von
endoskopischen Geräten (IEC 60601-2-18:1996)
Appareils électromédicaux - Partie 2: Règles particulières de sécurité pour appareils
d'endoscopie (CEI 60601-2-18:1996)
Ta slovenski standard je istoveten z: EN 60601-2-18:1996
ICS:
11.040.50 Radiografska oprema Radiographic equipment
SIST EN 60601-2-18:1998 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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NORME
CEI
INTERNATIONALE
IEC
601-2-18
INTERNATIONAL
Deuxième édition
STANDARD
Second edition
1996-08
Appareils électromédicaux –
Partie 2:
Règles particulières de sécurité
pour appareils d’endoscopie
Medical electrical equipment –
Part 2:
Particular requirements for the safety
of endoscopic equipment
CEI 1996 Droits de reproduction réservés Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized
utilisée sous quelque forme que ce soit et par aucun procédé, in any form or by any means, electronic or mechanical,
électronique ou mécanique, y compris la photocopie et les including photocopying and microfilm, without permission
microfilms, sans l'accord écrit de l'éditeur. in writing from the publisher
Bureau central de la Commission Electrotechnique Internationale 3, rue de Varembé Genève, Suisse
CODE PRIX
Commission Electrotechnique Internationale
U
International Electrotechnical Commission PRICE CODE
Pour prix, voir catalogue en vigueur
For price, see current catalogue
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601-2-18 IEC:1996 − 3 −
CONTENTS
Page
FOREWORD. 7
INTRODUCTION. 11
SECTION ONE − GENERAL
Clause
1 Scope and object . 13
2 Terminology and definitions . 15
3 General requirements. 19
4 General requirements for tests . 19
5 Classification. 19
6 Identification, marking and documents. 19
SECTION TWO − ENVIRONMENTAL CONDITIONS
SECTION THREE − PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
20 Dielectric strength . 25
SECTION FOUR − PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength . 25
22 Moving parts . 25
25 Expelled parts . 25
26 Vibration and noise. 27
27 Pneumatic and hydraulic power . 27
28 Suspended masses . 27
SECTION FIVE − PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
36 Electromagnetic compatibility . 27
SECTION SIX − PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN − PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
42 Excessive temperatures . 29
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization,
disinfection and compatibility . 33
SECTION EIGHT − ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
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601-2-18 IEC:1996 − 5 −
SECTION NINE − ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
SECTION TEN − CONSTRUCTIONAL REQUIREMENTS
57 MAINS PARTS, components and layout. 35
Figures
101 Identification of LIGHT EMISSION PART. 37
102 Measurement of CAPACITIVELY COUPLED HF CURRENT through the eyepiece . 37
Appendices/Annexes
D Symbols on marking . 39
L References – Publications mentioned in this standard. 41
AA Rationale. 43
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601-2-18 IEC:1996 − 7 −
INTERNATIONAL ELECTROTECHNICAL COMMISSION
_________
MEDICAL ELECTRICAL EQUIPMENT −−−−
Part 2: Particular requirements for the safety
of endoscopic 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 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. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 601-2-18 has been prepared by subcommittee 62D: Electromedical
equipment, of IEC technical committee 62: Electrical equipment in medical practice.
This second edition of IEC 601-2-18 cancels and replaces the first edition published in 1990.
This second edition constitutes a technical revision.
The text of this Particular Standard is based on the following documents:
FDIS Report on voting
62D/191/FDIS 62D/208/RVD
Full information on the voting for the approval of this Particular Standard can be found in the
report on voting indicated in the above table.
Annex AA is for information only.
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601-2-18 IEC:1996 − 9 −
In this Particular Standard, the following print types are used:
− Requirements, compliance with which can be tested, and definitions: in roman type;
− Explanations, advice, introductions, general statements and references: in smaller type;
− Test specifications: in italic types;
− TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD IEC 601-1 OR THIS PARTICULAR
STANDARD: SMALL CAPITALS.
The requirements are followed by specifications for the relevant tests.
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601-2-18 IEC:1996 − 11 −
INTRODUCTION
This Particular Standard concerns the safety of ENDOSCOPIC EQUIPMENT. The relationship of this
Particular Standard with IEC 601-1 (including the amendments) and the Collateral Standards is
explained in 1.3.
The revisions for this second edition include the following:
1) A new definition of ENDOSCOPE;
2) The inclusion of requirements for INTERCONNECTION CONDITIONS with ENDOSCOPICALLY-
USED ACCESSORIES.
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601-2-18 IEC:1996 − 13 −
MEDICAL ELECTRICAL EQUIPMENT −−
−−
Part 2: Particular requirements for the safety
of endoscopic equipment
SECTION ONE − GENERAL
The clauses and subclauses of this section of the General Standard apply except as follows:
1 Scope and object
This clause of the General Standard applies, except as follows:
1.1 Scope
Addition:
This Particular Standard specifies requirements for the safety of ENDOSCOPIC EQUIPMENT and its
INTERCONNECTION CONDITIONS with ENDOSCOPICALLY-USED ACCESSORIES.
NOTE − As the General Standard does not give requirements for the safety of APPLIED PARTS of different
MEDICAL ELECTRICAL EQUIPMENT when used together, this standard gives requirements for specific
INTERCONNECTION CONDITIONS commonly encountered during the use of ENDOSCOPES.
1.2 Object
Replacement:
The object of this Particular Standard to establish particular requirements for the safety of
ENDOSCOPIC EQUIPMENT and enable parts of ENDOSCOPIC EQUIPMENT to be tested together or
individually.
1.3 Particular Standards
Addition:
This Particular Standard amends and supplements a set of IEC publications, hereinafter
referred to as “General Standard”, consisting of IEC 601-1: 1988, Medical electrical equipment
− Part 1: General requirements for safety, amendment 1, amendment 2, IEC 601-1-1: 1992,
Medical electrical equipment − Part 1: General requirements for safety, 1. Collateral Standard:
Safety requirements for medical electrical systems, amendment 1, and IEC 601-1-2: 1993,
Medical electrical equipment − Part 1: General requirements for safety, 2. Collateral standard:
Electromagnetic compatibility − Requirements and tests.
For brevity, IEC 601-1 is referred to in this Particular Standard either as the “General Standard”
or as the “General Requirement(s)”, and IEC 601-1-1 and IEC 601-1-2 as the “Collateral
Standards”.
The term “this Standard” covers this Particular Standard, used together with the General
Standard and Collateral Standards.
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601-2-18 IEC:1996 − 15 −
The numbering of sections, clauses and subclauses of this Particular Standard corresponds
with that of the General Standard. The changes to the text of the General Standard are
specified by the use of the following words:
“Replacement” means that the clause or subclause of the General Standard is replaced
completely by the text of this Particular Standard.
“Addition” means that the text of this Particular Standard is additional to the requirements of
the General Standard.
“Amendment” means that the clause of subclause of the General Standard is amended as
indicated by the text of this Particular Standard.
Subclauses or figures which are additional to those of the General Standard are numbered
starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb),
etc.
Clauses and subclauses to which there is a rationale are marked with an asterisk *. These
rationales can be found in an informative annex AA. Annex AA is not part of this Particular
Standard and only gives additional information; it can never be the subject of testing.
Where there is no corresponding section, clause or subclause in this Particular Standard, the
section, clause or subclause of the General Standard or Collateral Standard applies without
modification.
Where it is intended that any part of the General Standard or Collateral Standards, although
possibly irrelevant, is not to be applied, a statement to that effect is given in this Particular
Standard.
A requirement of this Particular Standard replacing or modifying requirements of the General
Standard or Collateral Standards takes precedence over the corresponding General
Requirement(s).
2 Terminology and definitions
This clause of the General Standard applies, except as follows:
2.1.4 APPLIED PART
Addition:
For some ENDOSCOPIC EQUIPMENT, the APPLIED PART extends, as seen from the PATIENT, into
the SUPPLY UNIT(S) to the point(s) where the required separation is provided (see 17a) of the
General Standard).
Additional definitions:
*2.1.101 ENDOSCOPE
An APPLIED PART of MEDICAL ELECTRICAL EQUIPMENT introduced into a PATIENT to provide an
internal view or image for examination, diagnosis and/or therapy.
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601-2-18 IEC:1996 − 17 −
*2.1.102 ENDOSCOPICALLY-USED ACCESSORY
An accessory, which may be the APPLIED PART of MEDICAL ELECTRICAL EQUIPMENT that is not
ENDOSCOPIC EQUIPMENT, introduced into a PATIENT through the same orifice in the PATIENT as
the ENDOSCOPE.
*2.1.103 ENDOSCOPIC EQUIPMENT
An ENDOSCOPE together with its SUPPLY UNIT(S), as required for its intended use.
2.1.104 HIGH FREQUENCY SURGICAL EQUIPMENT
As defined by 2.1.101 of IEC 601-2-2.
2.1.105 LIGHT EMISSION PART
That part of the insertion portion of an ENDOSCOPE surrounding the light emission window,
delineated as follows:
The area of the surface of the insertion portion within three times the maximum diameter of the
insertion portion, measured at the tip (distal cover removed) for end viewing ENDOSCOPES or
the centre of the light emission window for side viewing ENDOSCOPES, measured in both
longitudinal directions from the centre of the light emission window, but with a minimum of
10 mm and a maximum of 25 mm.
See also figure 101.
*2.1.106 SUPPLY UNIT
That part of ENDOSCOPIC EQUIPMENT directly connected to an ENDOSCOPE, supplying functions
necessary for the ENDOSCOPE to produce the intended view or image, for example illumination
or signal processing.
2.1.107 ULTRASONIC MEDICAL DIAGNOSTIC AND MONITORING EQUIPMENT
As defined by 2.1.124 of future IEC 601-2-37**, “Safety of ultrasonic medical diagnostic and
monitoring equipment”.
*2.5.101 CAPACITIVELY COUPLED HF CURRENT
Unavoidable high frequency current flowing from an ENDOSCOPICALLY-USED ACCESSORY to the
endoscope.
2.12.101 INTERCONNECTION CONDITIONS
Conditions that shall be fulfilled for safe use when an energized ENDOSCOPE or energized
ENDOSCOPICALLY-USED ACCESSORY is used with an ENDOSCOPE.
_________
** At present Committee draft ref. 62B/290/CD.
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601-2-18 IEC:1996 − 19 −
3 General requirements
This clause of the General Standard applies, except as follows:
Additional subclauses:
*3.101 Where requirements for ENDOSCOPICALLY-USED ACCESSORIES given in other applicable
Particular Standards conflict with the requirements for INTERCONNECTION CONDITIONS of this
Particular Standard, the requirements of this Particular Standard shall take precedence.
*3.102 For the ultrasonic safety aspects of ENDOSCOPIC EQUIPMENT which is also ULTRASONIC
MEDICAL DIAGNOSTIC AND MONITORING EQUIPMENT, that part which is intended for ultrasonic
diagnosis or monitoring shall comply with the requirements of IEC 601-2-37 and the other parts
shall comply with the requirements of this Particular Standard.
*3.103 For SUPPLY UNITS providing a plurality of functions, for example high frequency
current, insufflation, suction, etc., the appropriate parts of these shall comply with the
requirements of relevant Particular Standards.
4 General requirements for tests
This clause of the General Standard applies, except as follows:
4.10 Addition:
This subclause does not apply to INTERCONNECTION CONDITIONS.
5 Classification
This clause of the General Standard applies, except as follows:
5.2 Amendment:
Delete TYPE B APPLIED PART.
*6 Identification, marking and documents
This clause of the General Standard applies, except as follows:
Addition:
ENDOSCOPIC EQUIPMENT having illumination lamps shall be provided with permanently affixed
and clearly legible markings near the lamps, either inside or outside the SUPPLY UNIT, giving
their MODEL OR TYPE REFERENCE. This requirement does not apply to illumination lamps built
into the distant end of ENDOSCOPES, for which the information shall be provided in the
instructions for use.
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts
d) Minimum requirements for marking on EQUIPMENT and on interchangeable parts
Replacement:
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601-2-18 IEC:1996 − 21 −
If the size of the EQUIPMENT or APPLIED PART specified in 6.1 or the nature of its ENCLOSURE
does not allow affixation of all specified markings, then at least the markings as indicated in
6.1e), 6.1f) and 6.1g) (not for PERMANENTLY INSTALLED EQUIPMENT), 6.1l) and 6.1q) (if
applicable) shall be affixed and the remaining markings shall be recorded in full in the
ACCOMPANYING DOCUMENTS. Where no marking is practicable, all information shall be included
in the ACCOMPANYING DOCUMENTS.
e) Indication of origin
Addition:
The name and/or trade mark of the manufacturer or supplier shall be marked on the APPLIED
PART.
f) MODEL OR TYPE REFERENCE
Addition:
The MODEL OR TYPE REFERENCE shall be marked on the APPLIED PART.
Additional item:
aa) Additional markings
At the option of the manufacturer, symbols to denote certain functions of ENDOSCOPIC
EQUIPMENT may be used but shall be explained in the ACCOMPANYING DOCUMENTS. If symbols
are used, appendix D lists those preferred symbols which shall be used to denote the functions
described.
6.8 ACCOMPANYING DOCUMENTS
6.8.2 Instructions for use
Additional items:
aa) General advice
The instructions for use of ENDOSCOPIC EQUIPMENT shall contain, where appropriate, advice
concerning its safe use, including the following:
*1) Prevention of SAFETY HAZARDS if ENDOSCOPIC EQUIPMENT loses functions.
2) That before each use, the outer surface of the portions of the ENDOSCOPE and any
ENDOSCOPICALLY-USED ACCESSORIES which are intended to be inserted into a PATIENT should be
checked to ensure there are no unintended rough surfaces, sharp edges or protrusions which
may cause a SAFETY HAZARD.
3) Warnings if surface temperatures on an APPLIED PART are likely to exceed 41 °C
(see 42.3).
4) Warnings that high energy radiated light may be transmitted from the light emission
window of the ENDOSCOPE, giving rise to high temperatures in front of the light emission
window, and advice on how to minimize associated SAFETY HAZARDS.
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601-2-18 IEC:1996 − 23 −
5) Replacement of the illumination lamp and prevention of SAFETY HAZARDS such as burns
and eye damage to the OPERATOR and USER.
6) Warnings regarding SAFETY HAZARDS resulting from gas embolism caused by, for example,
over-insufflation of air, inert gas prior to high frequency surgery or laser assist gas.
7) Whether there are any applicable INTERCONNECTION CONDITIONS.
8) Warnings that when ENDOSCOPES are used with energized ENDOSCOPICALLY-USED
ACCESSORIES, the PATIENT LEAKAGE CURRENTS may be additive. This is particularly important if a
TYPE CF APPLIED PART ENDOSCOPE is used, in which case a TYPE CF ENDOSCOPICALLY-USED
ACCESSORY should be used in order to minimize total PATIENT LEAKAGE CURRENT.
*bb) Advice when used with HIGH FREQUENCY SURGICAL EQUIPMENT
When ENDOSCOPIC EQUIPMENT and/or ENDOSCOPICALLY-USED ACCESSORIES is/are used with HIGH
FREQUENCY SURGICAL EQUIPMENT, advice concerning their safe use shall be given, including the
following:
1) The high frequency compatibility of ENDOSCOPES and ENDOSCOPICALLY-USED ACCESSORIES,
by stating the maximum RATED recurring peak voltage of the ENDOSCOPE or ENDOSCOPICALLY-
USED ACCESSORY for each mode of intended use (see 42.101), together with instructions that
higher recurring peak voltages shall not be used.
2) Avoidance of a SAFETY HAZARD in the event of explosive gas concentrations being present
in the area of use of HIGH FREQUENCY ENDOSCOPICALLY-USED ACCESSORIES.
*cc) Advice when used with laser equipment
When ENDOSCOPIC EQUIPMENT and/or ENDOSCOPICALLY-USED ACCESSORIES is/are used with
laser equipment, advice concerning their safe use shall be given, including avoidance of
potential eye damage to the OPERATOR by, for example, wearing suitable protective filtering
spectacles or by inserting a suitable filter in the eyepiece of the ENDOSCOPE.
dd) Advice when used with other MEDICAL ELECTRICAL EQUIPMENT
When ENDOSCOPIC EQUIPMENT is used with other MEDICAL ELECTRICAL EQUIPMENT, advice on the
avoidance of potential SAFETY HAZARDS caused by their use together shall also be given.
SECTION TWO − ENVIRONMENTAL CONDITIONS
The clauses and subclauses of this section of the General Standard apply.
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601-2-18 IEC:1996 − 25 −
SECTION THREE − PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
The clauses and subclauses of this section of the General Standard apply, except as follows:
20 Dielectric strength
This clause of the General Standard applies, except as follows:
*20.2 Requirements for EQUIPMENT with an APPLIED PART
Replacement of line beginning B-a:
B-a Between the APPLIED PART (PATIENT CIRCUIT) and LIVE parts; and between the outer
surface of the ENDOSCOPE and any live circuit in the ENDOSCOPE.
Replacement of line beginning B-d:
B-d Between an F-TYPE APPLIED PART (PATIENT CIRCUIT) and the ENCLOSURE including SIGNAL
INPUT PARTS and SIGNAL OUTPUT PARTS; and between PROTECTIVELY EARTHED parts or
parts connected to a FUNCTIONAL EARTH TERMINAL enclosing any LIVE circuit in the
ENDOSCOPE and the outer surface of the ENDOSCOPE.
SECTION FOUR − PROTECTION AGAINST MECHANICAL HAZARDS
The clauses and subclauses of this section of the General Standard apply, except as follows:
*21 Mechanical strength
This clause of the General Standard applies, except as follows:
Addition:
This clause does not apply to ENDOSCOPES and ENDOSCOPICALLY-USED ACCESSORIES.
22 Moving parts
This clause of the General Standard applies, except as follows:
Addition:
This clause does not apply to ENDOSCOPES and ENDOSCOPICALLY-USED ACCESSORIES.
25 Expelled parts
This clause of the General Standard applies, except as follows:
Addition:
This clause does not apply to ENDOSCOPES and ENDOSCOPICALLY-USED ACCESSORIES.
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601-2-18 IEC:1996 − 27 −
26 Vibration and noise
This clause of the General Standard applies, except as follows:
Addition:
This clause does not apply to ENDOSCOPES and ENDOSCOPICALLY-USED ACCESSORIES.
27 Pneumatic and hydraulic power
This clause of the General Standard applies, except as follows:
Addition:
This clause does not apply to ENDOSCOPES and ENDOSCOPICALLY-USED ACCESSORIES.
28 Suspended masses
This clause of the General Standard applies, except as follows:
Addition:
This clause does not apply to ENDOSCOPES and ENDOSCOPICALLY-USED ACCESSORIES.
SECTION FIVE − PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
The clauses and subclauses of this section of the General Standard apply, except as follows:
36 Electromagnetic compatibility
This clause of the General Standard applies, except as follows:
Addition:
The following are considered to be in Group 2 of CISPR 11:
− ultrasonic ENDOSCOPE and its SUPPLY UNIT;
− ENDOSCOPICALLY-USED ACCESSORY and its associated MEDICAL ELECTRICAL EQUIPMENT for
intracorporeal lithotripsy;
− ENDOSCOPICALLY-USED ACCESSORY and its associated MEDICAL ELECTRICAL EQUIPMENT for
ultrasonic aspiration of tissue.
SECTION SIX − PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES
The clauses and subclauses of this section of the General Standard apply.
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601-2-18 IEC:1996 − 29 −
SECTION SEVEN − PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
The clauses and subclauses of this section of the General Standard apply, except as follows:
42 Excessive temperatures
This clause of the General Standard applies, except as follows:
*42.3 Replacement of requirement only:
In NORMAL USE, allowable surface temperatures of APPLIED PARTS of ENDOSCOPIC EQUIPMENT not
intended to supply heat to a PATIENT shall comply with the following requirements:
a) Portions which are held by the OPERATOR for short periods only shall not exceed the
applicable maximum temperatures for accessible surfaces of handles, knobs, grips and the
like in table Xa of the General Standard.
Light guide connectors connecting to either a SUPPLY UNIT or an ENDOSCOPE may exceed
these temperatures, but appropriate warnings and advice on measures that can be taken to
avoid SAFETY HAZARDS to the OPERATOR shall be included in the instructions for use (see
6.8.2 aa) 3)).
b) Portions which are continuously held by the OPERATOR shall not exceed the applicable
maximum temperatures for accessible surfaces of handles, knobs, grips and the like in
table Xa of the General Standard.
c) The temperature of the insertion portion, except for the LIGHT EMISSION PART, shall not
exceed 41 °C. However, when used with an ENDOSCOPICALLY-USED ACCESSORY, the surface
temperature may exceed 41 °C for brief periods only, up to a maximum of 50 °C. In such
circumstances, the instructions for use of the ENDOSCOPICALLY-USED ACCESSORY shall give
appropriate warnings and advice on measures that can be taken to avoid SAFETY HAZARD to
the PATIENT.
The LIGHT EMISSION PART may exceed 41 °C, but appropriate warnings and advice on
measures that can be taken to avoid risks to the PATIENT and OPERATOR shall be given in the
instructions for use. These warnings shall include a description of the potential clinical
consequences (for instance permanent issue damage or coagulation) of high surface
temperatures (see 6.8.2 aa) 3)).
Compliance with requirements b) and c) above are checked at an ambient temperature of
25 °C.
42.5 Guards
Addition:
Illumination lamps of light sources may be accessible without the aid of a TOOL, but there shall
be marking on or near the ACCESS COVER provided for lamp replacement (preferably by use of
symbol 5041 of IEC 417) and a caution shall be included in the instructions for use (see 6.8.2
aa) 5)).
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601-2-18 IEC:1996 − 31 −
Additional subclause:
*42.101 Thermal hazards from the use of ENDOSCOPES and ENDOSCOPICALLY-USED ACCES-
SORIES which are the APPLIED PARTS of HIGH FREQUENCY SURGICAL EQUIPMENT
Sufficient separation and/or insulation shall be provided between an ENDOSCOPE and
ENDOSCOPICALLY-USED ACCESSORIES which are the APPLIED PARTS of HIGH FREQUENCY SURGICAL
EQUIPMENT when used together, to protect PATIENTS and/or OPERATORS from SAFETY HAZARDS
associated with a release of thermal energy.
The separation and/or insulation may either be provided on the ENDOSCOPICALLY-USED
ACCESSORY or on the ENDOSCOPE or a proportion on each.
This requirement replaces subclause 101.3.2 of IEC 601-2-2 for the INTERCONNECTION
CONDITIONS of ENDOSCOPICALLY-USED ACCESSORIES that are the APPLIED PARTS of HIGH
FREQUENCY SURGICAL EQUIPMENT.
Compliance is checked as follows:
1) Test of INTERCONNECTION CONDITIONS for high frequency applications
Tests shall be performed using a test voltage related to the RATED high frequency recurring
peak voltage(s) specified by the manufacturer of the ENDOSCOPE and/or ENDOSCOPICALLY-USED
ACCESSORY in the instructions for use (see 6.8.2 bb)), as detailed in the test methods below.
The purpose of these tests is to check the high frequency strength of the insulated parts of the
ENDOSCOPE and ENDOSCOPICALLY-USED ACCESSORY when used together.
The test samples shall be preconditioned by being immersed in physiological saline solution for
a period of at least 12 h, but no longer than 24 h, immediately prior to the tests.
Those parts of the test samples which are not insulated in NORMAL USE shall be adequately
protected against contact with the saline solution during both the pre-conditioning and the
tests.
A quantity of transformer oil is added to the saline solution, just sufficient to produce a visible
continuous film on the surface, in order to reduce the curvature of the meniscus.
Tests shall be performed in each of the main operating modes, as specified in the instructions
for use of the ENDOSCOPE and/or ENDOSCOPICALLY-USED ACCESSORY, in accordance with the test
procedures detailed below.
The test volt
...
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