EN 60601-2-8:1997

Medical electrical equipment - Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV

Specifies particular requirements for the safety of therapeutic X-ray generators operating with nominal X-ray tube voltages from 10 kV to 400 kV inclusive.

Medizinische elektrische Geräte - Teil 2: Besondere Festlegungen für die Sicherheit von Therapie-Röntgeneinrichtungen im Betriebsbereich von 10 kV bis 1 MV

Appareils électromédicaux - Partie 2: Règles particulières de sécurité pour les équipements à rayonnement X de thérapie fonctionnant dans la gamme de 10 kV à 1 MV

Spécifie les règles particulières de sécurité pour groupes radiogènes de radiothérapie fonctionnant à des hautes tensions nominales comprises entre 10 kV et 400 kV inclus.

Medicinska električna oprema - 2. del: Posebne varnostne zahteve za terapevtsko rentgensko opremo, ki deluje v območju od 10 kV do 1 MV (IEC 60601-2-8:1987)

General Information

• Status: Withdrawn
• Publication Date: 08-Sep-1997
• Withdrawal Date: 08-Mar-1998
• 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
• Start Date: 14-Apr-2018
• Completion Date: 14-Apr-2018
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning 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 60601-2-8:1998 - Medical electrical equipment - Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV (IEC 60601-2-8:1987)

Relations

• Replaced By: EN 60601-2-8:2015 - Medical electrical equipment - Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
• Effective Date: 28-Jan-2023
• Amended By: EN 60601-2-8:1997/A1:1997 - Medical electrical equipment - Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
• Effective Date: 29-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-8:1998
01-oktober-1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQHYDUQRVWQH]DKWHYH]DWHUDSHYWVNR
UHQWJHQVNRRSUHPRNLGHOXMHYREPRþMXRGN9GR09,(&
Medical electrical equipment - Part 2: Particular requirements for the safety of
therapeutic X-ray equipment operating in the range 10 kV to 1 MV (IEC 60601-2-8:1987)
Medizinische elektrische Geräte - Teil 2: Besondere Festlegungen für die Sicherheit von
Therapie-Röntgeneinrichtungen im Betriebsbereich von 10 kV bis 1 MV (IEC 60601-2-
8:1987)
Appareils électromédicaux - Partie 2: Règles particulières de sécurité pour les
équipements à rayonnement X de thérapie fonctionnant dans la gamme de 10 kV à 1 MV
(CEI 60601-2-8:1987)
Ta slovenski standard je istoveten z: EN 60601-2-8:1997
ICS:
11.040.50 Radiografska oprema Radiographic equipment
SIST EN 60601-2-8:1998 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-8:1998

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SIST EN 60601-2-8:1998

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SIST EN 60601-2-8:1998

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SIST EN 60601-2-8:1998
NORME CEI
INTERNATIONALE IEC
601-2-8
INTERNATIONAL
Première
édition
STAN DARD
First edition
1987
Appareils électromédicaux
Deuxième partie:
Règles particulières de sécurité pour
groupes radiogènes de radiothérapie
Medical electrical equipment
Part 2:
Particular requirements for the safety of
therapeutic X-ray generators
© CEI 1987 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
Commission Electrotechnique Internationale CODE PRIX
VV
International Electrotechnical Commission PRICE CODE
IEC
MemayHapoimaa 3nearporexHH4ecaaa Komuccma
• Pour prix, voir catalogue en vigueur
For price, see current catalogue

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SIST EN 60601-2-8:1998
3
601-2-8 © I E C 1987
CONTENTS
Page
FOREWORD 9
PREFACE 9
SECTION ONE - GENERAL
Clause
11
1. Scope and object
11
1.1 Scope
11
1.2 Object
11
1.3 Particular Standards
11
1.3.101 Relation to the General Standard
13
1.3.102 Superseded I E C Standard
13
1.4 Environmental conditions
2. Terminology and definitions 13
15
3. General requirements
15
3.101 Conventional meaning of electrical quantities
15
4. General requirements for tests
15
4.1 Type tests and routine tests
4.7 Supply and test voltages, type of current, nature of supply, frequency 15
15
4.10 Moisture pre-conditioning treatment
15
5. Classification
17
6. Identification, marking and documents
17
6.1 Marking on the outside of equipment and equipment parts
6.2 Marking on the inside of equipment and equipment pa rts 19
19
6.7 Indicator lights and push-buttons
21
6.8 ACCOMPANYING DOCUMENTS
Power input 25
7.
SECTION TWO - SAFETY REQUIREMENTS
8. Basic safety categories 25
9. Removable protective means 25
25
10. Special environmental conditions
Special measures with respect to safety 25
11.
12. SINGLE FAULT CONDITION 25
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
25
13. General
25
14. Requirements related to classification
25
15. Limitation of voltage and/or current
27
16. Enclosures and PROTECTIVE COVERS
17. Insulation and PROTECTIVE IMPEDANCES 27
27
18. Earthing and potential equalization
19. Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS 27
19.3 Allowable values 29
20. Dielectric strength 29
20.3 Values of test voltages 29
20.4 31
Tests
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
31
21. Mechanical strength
31
22. Moving parts
31
23. Surfaces, corners and edges
31
24. Stability and transportability

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SIST EN 60601-2-8:1998
- 5-
601-2-8 © I E C 1987
33
Expelled parts
25.
Vibration and noise 33
26.
33
27. Pneumatic and hydraulic power
33
28. Suspended masses
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
33
29. X-radiation
X-RAY GENERATORS 33
29.1 X-RADIATION generated by therapeutic
43
29.101 NORMAL CONDITION
43
29.102 SINGLE FAULT CONDITION
49
30. Alpha, beta, gamma, neutron radiation and other particle radiation
49
31. Microwave radiation
49
32. Light radiation (including visual
...