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
SIST EN 60601-2-18:1998/A1:2002
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
SIST EN 60601-2-18:1998/A1:2002 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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INTERNATIONAL IEC
STANDARD
60601-2-18
1996
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
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– 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:
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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 I
...
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