EN 60601-2-18:1996/A1:2000
(Amendment)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
EN following parallel vote * dav postponed to dav+6months
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
Medicinska električna oprema - 2. del: Posebne varnostne zahteve za endoskopsko opremo - Dopolnilo A1 (IEC 60601-2-18:1996/A1:2000)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2002
0HGLFLQVNDHOHNWULþQDRSUHPDGHO 3RVHEQHYDUQRVWQH]DKWHYH]D
HQGRVNRSVNRRSUHPR'RSROQLOR$ ,(& $
Medical electrical equipment - Part 2: Particular requirements for the safety of
endoscopic equipment (IEC 60601-2-18:1996/A1:2000)
Medizinische elektrische Geräte - Teil 2: Besondere Festlegungen für die Sicherheit von
endoskopischen Geräten (IEC 60601-2-18:1996/A1:2000)
Appareils électromédicaux - Partie 2: Règles particulières de sécurité pour appareils
d'endoscopie (CEI 60601-2-18:1996/A1:2000)
Ta slovenski standard je istoveten z: EN 60601-2-18:1996/A1:2000
ICS:
11.040.50 Radiografska oprema Radiographic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
INTERNATIONAL IEC
STANDARD
60601-2-18
AMENDMENT 1
2000-07
Amendment 1
Medical electrical equipment –
Part 2-18:
Particular requirements for the safety
of endoscopic equipment
Amendement 1
Appareils électromédicaux –
Partie 2-18:
Règles particulières de sécurité
pour appareils d'endoscopie
IEC 2000 Copyright - all rights reserved
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: +41 22 919 0300 e-mail: inmail@iec.ch IEC web site http://www.iec.ch
Commission Electrotechnique Internationale
PRICE CODE
K
International Electrotechnical Commission
For price, see current catalogue
– 2 – 60601-2-18 Amend. 1 © IEC:2000(E)
FOREWORD
This amendment has been prepared by sub-committee 62D: Electromedical equipment, of IEC
technical committee 62: Electrical equipment in medical practice.
The text of this amendment is based on the following documents:
FDIS Report on Voting
62D/360/FDIS 62D/365/RVD
Full information on the approval of this amendment can be found in the report on voting
indicated in the above table.
The committee has decided that the contents of the base publication and its amendments will
remain unchanged until 2002. At this date, the publication will be:
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
-----------------
INTRODUCTION
The only significant amendment relates to the addition of an exclusion from subclause 56.3 c)
of Amendment 2 of the General Standard, as this subclause was added to the General
Standard amendment after the text of the 2nd edition of IEC 60601-2-18 had been finalized,
and was therefore not taken into account during its preparation.
Page 5
CONTENTS
Add the following after the SECTION 10 heading:
56 Components and general assembly. 35
Page 11
INTRODUCTION
Replace the text of the first paragraph as follows:
This Particular Standard concerns the safety of ENDOSCOPIC EQUIPMENT. The relationship of
this Particular Standard with IEC 60601-1 (including the amendments) and the Collateral
Standards is explained in 1.3 and 1.5 respectively.
Page 13
1.3 Particular Standards
Replace the text of the instruction and the first three paragraphs of this subclause as follows:
60601-2-18 Amend.1 © IEC:2000(E) – 3 –
Replacement:
This Particular Standard amends and supplements a set of IEC publications, hereinafter
referred to as the "General Standard", consisting of IEC 60601-1: 1988, Medical electrical
equipment – Part 1: General requirements for safety, amendment 1, amendment 2 and
associated Collateral Standards (see subclause 1.5).
For brevity, IEC 60601-1 is referred to in this Particular Standard either as the "General
Standard" or as the "General Requirement(s)".
The term "this Standard" covers this Particular Standard, used together with the General
Standard and relevant Collateral Standards.
Page 15
In the first line of the fourth paragraph on this page, replace ".clause of subclause." by
".clause or subclause." (English version only).
In the second line of the eighth paragraph on this page, replace ".irrelevant." by
".relevant." (English version only).
In the ninth paragraph on this page, replace the text as follows:
A requirement of this Particular Standard replacing or modifying requirements of the General
Standard takes precedence over the corresponding General Requirement(s).
Add, after 1.3 the following new subclause 1.5:
1.5 Collateral Standards
Addition:
The following Collateral Standards apply to ENDOSCOPIC EQUIPMENT:
IEC 60601-1-1: 1992, Medical electrical equipment – Part 1: General requirements for safety –
Section 1: Collateral Standard: Safety requirements for medical electrical systems,
amendment 1; IEC 60601-1-2: 1993, Medical electrical equipment – Part 1: General
requirements for safety, 2. Collateral Standard: Electromagnetic compatibility - Requirements
and tests, and IEC 60601-1-4: 1996, Medical electrical equipment – Part 1: General
requirements for safety, 4. Collateral Standard: Programmable electrical medical systems.
2.1.4 APPLIED PART
Replace the subclause number by 2.1.5 so that it reads:
2.1.5 APPLIED PART
(English version only)
Amend the text at end of subclause 2.1.5, within the existing parentheses, as follows:
", see 17 a) and 17 c) of the General Standard"
– 4 – 60601-2-18 Amend. 1 © IEC:2000(E)
Page 17
*2.1.103 ENDOSCOPIC EQUIPMENT
Delete the asterisk (*) from in front of the subclause number, so that it reads:
2.1.103 ENDOSCOPIC EQUIPMENT
2.1.104 HIGH FREQUENCY SURGICAL EQUIPMENT
Replace "IEC 601-2-2" by "IEC 60601-2-2".
2.1.105 LIGHT EMISSION PART
In the second line of this definition, replace ".end." by ".forward.".
*2.5.101 CAPACITIVELY COUPLED HF CURRENT
In the second line of this definition, replace ".endoscope." by ".ENDOSCOPE." (English
version only).
Page 19
*6 Identification, marking and documents
In the fourth line of the paragraph headed "Addition", replace ".distant." by ".distal."
(English version only).
Page 21
After the item entitled f) MODEL OR TYPE REFERENCE, and before the line which reads
"Additional item", add the following subclause title:
6.4 Symbols
aa) Additional markings
In the third line of this requirement, replace ".shall." by ".may.".
6.8 ACCOMPANYING DOCUMENTS
6.8.2 Instructions for use
*bb) Advice when used with HIGH FREQUENCY SURGICAL EQUIPMENT
In the third line of requirement 1 of this item, on page 23, replace ".for each mode of
intended use." by ".for the mode(s) of intended use.".
Page 25
20 Dielectric strength
20.2 Requirements for EQUIPMENT with an APPLIED PART
In the item commencing "B-a", replace ".live." by ".LIVE.".
60601-2-18 Amend.1 © IEC:2000(E) – 5 –
Page 29
42 Excessive temperature
*42.3 Replacement of requirement only
In the fourth line of the second paragraph of item c) of this subclause, replace ".issue." by
".tissue." (English version only).
Replace the test requirement by:
Compliance with the above requirements is checked at an ambient temperature of 25 °C.
42.5 Guards
In the third line of this requirement, replace "IEC 417" by "IEC 60417".
Page 31
*42.101 Thermal hazards from the use of ENDOSCOPES and ENDOSCOPICALLY-USED
ACCESSORIES which are the APPLIED PARTS OF HIGH FREQUENCY SURGICAL
EQUIPMENT
Replace the text of this subclause as follows:
a) INTERCONNECTION CONDITIONS for high frequency applications
Sufficient protection shall be provided between an ENDOSCOPE AND ENDOSCOPICALLY-USED
ACCESSORIES which are the APPLIED PARTS of HF SURGICAL EQUIPMENT when used together to
protect the PATIENT and/or OPERATOR from SAFETY HAZARDS associated with thermal energy.
Sufficient protection will be achieved if the insulation material is stable when subjected to
thermal stress and the necessary dielectric strength is present.
The insulation may be provided either on the ENDOSCOPICALLY-USED ACCESSORY or on the
ENDOSCOPE or a proportion on each.
This requirement replaces subclause 59.103.2 of IEC 60601-2-2, 3rd edition, for the
INTERCONNECTION CONDITIONS of ENDOSCOPICALLY-USED ACCESSORIES which are the APPLIED
PARTS of HF SURGICAL EQUIPMENT.
Compliance is checked as follows:
The tests shall be performed at 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 following test
methods.
The purpose of these tests is:
− to check the stability of the insulation material when subjected to thermal stress; and
− to check the dielectric strength of the insulation.
Test samples representative of all the different insulation types and configurations used in the
ENDOSCOPE and/or ENDOSCOPICALLY-USED ACCESSORY shall be prepared and preconditioned by
immersion in physiological saline solution for a period of at least 12 h, but no longer than
24 h, immediately prior to the tests.
– 6 – 60601-2-18 Amend. 1 © IEC:2000(E)
Those parts of the test samples which are not insulated in NORMAL USE shall be adequately
protected against contact with the saline solution during preconditioning, and this protection
shall be left in place during the tests.
1) Insulation material thermal stability test
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.
The test samples are partially immersed in physiological saline solution, so that a part of the
relevant insulated po
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