EN 60601-2-36:1997

Medical electrical equipment - Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy

Applies to the safety of equipment for extracorporeally induced lithotripsy, i.e. device for treatment with extracorporally generated pressure pulses. The applicability of this standard is limited to components directly involved in the lithotripsy treatment, such as, but not limited to, the generator of the pressure pulse, patient support device, and their interactions with imaging and monitoring devices.

Medizinische elektrische Geräte - Teil 2: Besondere Festlegungen für die Sicherheit von Geräten zur extrakorporal induzierten Lithotripsie

Appareils électromédicaux - Partie 2: Règles particulières de sécurité des appareils pour lithotritie créée de façon extra-corporelle

S'applique à la sécurité des appareils pour lithotritie créée de façon extra-corporelle, c'est-à-dire des dispositifs pour la lithotritie à impulsions de pression créées de façon extra-corporelle. La possibilité d'appliquer la présente norme est limitée aux éléments directement en cause dans le traitement par lithotritie tels que, sans être exclusif, le générateur d'impulsions de pression, le dispositif supportant le patient, et leurs interactions avec les dispositifs d'imagerie et de surveillance.

Medicinska električna oprema - 2. del: Posebne varnostne zahteve za opremo za zunajtelesno inducirano litotripsijo (IEC 60601-2-36:1997)

General Information

• Status: Withdrawn
• Publication Date: 06-May-1997
• Withdrawal Date: 30-Nov-1997
• ICS: 11.040.60 - Therapy 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: 22-May-2018
• Completion Date: 22-May-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 60601-2-36:1998 - Medical electrical equipment - Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy (IEC 60601-2-36:1997)

Relations

• Replaced By: EN 60601-2-36:2015 - Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-36:1998
01-september-1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQHYDUQRVWQH]DKWHYH]DRSUHPR]D
]XQDMWHOHVQRLQGXFLUDQROLWRWULSVLMR,(&
Medical electrical equipment - Part 2: Particular requirements for the safety of equipment
for extracorporeally induced lithotripsy (IEC 60601-2-36:1997)
Medizinische elektrische Geräte - Teil 2: Besondere Festlegungen für die Sicherheit von
Geräten zur extrakorporal induzierten Lithotripsie (IEC 60601-2-36:1997)
Appareils électromédicaux - Partie 2: Règles particulières de sécurité des appareils pour
lithotritie créée de façon extra-corporelle (CEI 60601-2-36:1997)
Ta slovenski standard je istoveten z: EN 60601-2-36:1997
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
11.040.60 Terapevtska oprema Therapy equipment
SIST EN 60601-2-36:1998 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-36:1998

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SIST EN 60601-2-36:1998

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SIST EN 60601-2-36:1998

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SIST EN 60601-2-36:1998

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SIST EN 60601-2-36:1998

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SIST EN 60601-2-36:1998
NORME
CEI
INTERNATIONALE
IEC
60601-2-36
INTERNATIONAL
Première édition
STANDARD
First edition
1997-03
Appareils électromédicaux –
Partie 2:
Règles particulières de sécurité des appareils
pour lithotritie créée de façon extra-corporelle
Medical electrical equipment –
Part 2:
Particular requirements for the safety of equipment
for extracorporeally induced lithotripsy
 IEC 1997 Droits de reproduction réservés  Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni utilisée No part of this publication may be reproduced or utilized in
sous quelque forme que ce soit et par aucun procédé, électronique any form or by any means, electronic or mechanical, including
ou mécanique, y compris la photocopie et les microfilms, sans photocopying and microfilm, without permission in writing from
l'accord écrit de l'éditeur. the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: [phone] e-mail: [e-mail] IEC web site http: //www.iec.ch
CODE PRIX
Commission Electrotechnique Internationale
PRICE CODE Q
International Electrotechnical Commission
Pour prix, voir catalogue en vigueur
For price, see current catalogue

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SIST EN 60601-2-36:1998
60601-2-36 © IEC:1997 – 3 –
CONTENTS
Page
FOREWORD . 5
INTRODUCTION . 7
Clause
SECTION ONE: GENERAL
1 Scope and object. 9
2 Terminology and definitions . 11
6 Identification, marking and documents . 13
SECTION TWO: ENVIRONMENTAL CONDITIONS
10 Environmental conditions . 15
SECTION THREE: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS . 17
20 Dielectric strength. 17
SECTION FOUR: PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength. 17
22 Moving parts. 21
24 Stability in NORMAL USE . 23
26 Vibration and noise. 23
28 Suspended masses. 25
SECTION FIVE: PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
35 Acoustical energy (including ultrasonics) . 25
36 Electromagnetic compatibility. 25
SECTION SEVEN: PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
42 Excessive temperat
...