EN 60601-2-18:1996
(Main)Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment
Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment
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
Appareils électromédicaux - Partie 2: Règles particulières de sécurité pour appareils d'endoscopie
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
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Standards Content (Sample)
SLOVENSKI STANDARD
01-september-1998
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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
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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
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CODE PRIX
Commission Electrotechnique Internationale
U
International Electrotechnical Commission PRICE CODE
Pour prix, voir catalogue en vigueur
For price, see current catalogue
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
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
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.
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.
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.
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.
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.
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 windo
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