EN 60601-2-18:1996

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

• Status: Withdrawn
• Publication Date: 29-Sep-1996
• Withdrawal Date: 30-Apr-1997
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Parallel Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 15-Sep-2018
• Completion Date: 15-Sep-2018
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN 60601-2-18:1998 - Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment (IEC 60601-2-18:1996)

Relations

• Replaced By: EN 60601-2-18:2015 - Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
• Effective Date: 29-Jan-2023
• Amended By: EN 60601-2-18:1996/A1:2000 - Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment
• Effective Date: 29-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-18:1998
01-september-1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQHYDUQRVWQH]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
...