EN 60601-2-7:1998

Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators

Applies to high-voltage generators of medical diagnostic X-ray generators and to their subassemblies including the following : - high-voltage generators that are integrated with an X-ray tube assembly; - high-voltage generators of radiotherapy treatment simulators. The object of this standard is to establish particular requirements to ensure safety and to specify methods for demonstrating compliance with those requirements.

Medizinische elektrische Geräte - Teil 2-7: Besondere Festlegungen für die Sicherheit von Röntgengeneratoren von diagnostischen Röntgenstrahlenerzeugern

Appareils électromédicaux - Partie 2-7: Règles particulières de sécurité pour générateurs radiographiques de groupes radiogènes de diagnostic

Medicinska električna oprema - 2-7. del: Posebne varnostne zahteve za visokonapetostne napajalnike generatorjev diagnostičnih rentgenskih žarkov (IEC 60601-2-7:1998)

General Information

• Status: Withdrawn
• Publication Date: 08-Apr-1998
• Withdrawal Date: 31-Dec-2000
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62B - IEC_SC_62B
• Parallel Committee: IEC/SC 62B - IEC_SC_62B
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 01-Aug-2012
• 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 60601-2-7:1998 - Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators (IEC 60601-2-7:1998)

Relations

• Replaces: HD 395.2.7 S1:1989 - Medical electrical equipment - Part 2: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators
• Effective Date: 28-Jan-2023
• Replaced By: EN 60601-2-54:2009 - Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
• Effective Date: 28-Jan-2023
• Replaced By: EN 60601-2-65:2013 - Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-7:1998
01-september-1998
1DGRPHãþD
SIST HD 395.2.7 S1:1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQHYDUQRVWQH]DKWHYH]D
YLVRNRQDSHWRVWQHQDSDMDOQLNHJHQHUDWRUMHYGLDJQRVWLþQLKUHQWJHQVNLKåDUNRY,(&

Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-
voltage generators of diagnostic X-ray generators (IEC 60601-2-7:1998)
Medizinische elektrische Geräte - Teil 2-7: Besondere Festlegungen für die Sicherheit
von Röntgengeneratoren von diagnostischen Röntgenstrahlenerzeugern (IEC 60601-2-
7:1998)
Appareils électromédicaux - Partie 2-7: Règles particulières de sécurité pour générateurs
radiographiques de groupes radiogènes de diagnostic (IEC 60601-2-7:1998)
Ta slovenski standard je istoveten z: EN 60601-2-7:1998
ICS:
11.040.50 Radiografska oprema Radiographic equipment
SIST EN 60601-2-7:1998 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-7:1998

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SIST EN 60601-2-7:1998

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SIST EN 60601-2-7:1998

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SIST EN 60601-2-7:1998
INTERNATIONAL
IEC
STANDARD
60601-2-7
Second edition
1998-02
Medical electrical equipment –
Part 2-7:
Particular requirements for the safety of
high-voltage generators of diagnostic
X-ray generators
Appareils électromédicaux –
Partie 2-7:
Règles particulières de sécurité pour générateurs
radiographiques de groupes radiogènes de diagnostic
 IEC 1998 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 in
utilisée sous quelque forme que ce soit et par aucun any form or by any means, electronic or mechanical,
procédé, électronique ou mécanique, y compris la photo- including photocopying and microfilm, without permission in
copie et les microfilms, sans l'accord écrit de l'éditeur. writing from 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 X
International Electrotechnical Commission
Pour prix, voir catalogue en vigueur
For price, see current catalogue

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SIST EN 60601-2-7:1998
– 2 – 60601-2-7 © IEC:1998 (E)
CONTENTS
Page
FOREWORD .4
SECTION 1: GENERAL
Clause
1 Scope and object . 5
1.1 Scope . 5
1.2 Object. 5
1.3 Particular Standards . 6
2 Terminology and definitions. 7
2.101 Qualifying conditions for defined terms . 8
3 General requirements . 9
5 Classification . 9
6 Identification, marking and documents. 9
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts . 9
6.7 Indicator lights and push-buttons. 10
6.8 ACCOMPANYING DOCUMENTS . 11
SECTION 2: ENVIRONMENTAL CONDITIONS
10 Environmental conditions . 13
SECTION 3: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
15 Limitation of voltage and/or energy. 15
16 ENCLOSURES and PROTECTIVE COVERS . 15
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS . 15
19.3 Allowable values. 15
20 Dielectric str
...