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

IEC 60601-2-8:2010 establishes particular basic safety and essential performance requirements for therapeutic X-ray equipment with nominal X-ray tube voltages in the range 10 kV to 1 MV when connected to alternating current supply mains. It includes the requirements for accuracy and reproducibility of performance to the extent that these are related to radiation quality and the quantity of ionizing radiation produced and thus must be considered as aspects of safety. This second edition cancels and replaces the first edition of IEC 60601-2-8. This edition constitutes a technical revision which brings this standard in line with the third edition of IEC 60601-1 and its collateral standards.

Medizinische elektrische Geräte - Teil 2-8: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Therapie-Röntgeneinrichtungen im Bereich von 10 kV bis 1 MV

Appareils électromédicaux - Partie 2-8: Exigences particulières pour la sécurité de base et les performances essentielles des équipements à rayonnement X de thérapie fonctionnant dans la gamme de 10 kV à 1 MV

La CEI 60601-2-8:2010 établit des exigences particulières pour la sécurité de base et les performances essentielles des équipements à rayonnement X de thérapie fonctionnant à des hautes tensions radiogènes nominales comprises entre 10 kV et 1 MV quand ils sont reliés à un réseau d'alimentation fournissant du courant alternatif. Elle établit des exigences pour la précision et à la reproductibilité des caractéristiques dans la mesure où celles-ci sont en relation avec la qualité de rayonnement et les grandeurs liées au rayonnement ionisant émis et où elles doivent donc être considérées comme des aspects de la sécurité. Cette deuxième édition annule et remplace la première édition de la CEI 60601-2-8. Cette édition constitue une révision technique qui aligne la présente norme sur la troisième édition de la CEI 60601-1 et ses normes collatérales.

Medicinska električna oprema - 2-8. del: Posebne zahteve za osnovno varnost in bistvene lastnosti terapevtske rentgenske opreme, ki deluje v območju od 10 kV do 1 MV

Ta mednarodni standard se nanaša na osnovno varnost in bistvene lastnosti terapevtske RENTGENSKE OPREME z NAZIVNO NAPETOSTJO RENTGENSKE CEVI v razponu od 10 kV do 1 MV, ko je priključena na NAPAJALNO OMREŽJE z izmeničnim tokom, v nadaljevanju: MEDICINSKA ELEKTRIČNA (ME) OPREMA.
OPOMBA: Ta standard obravnava TELERADIOTERAPIJO IN BRAHITERAPIJO.
Če je točka ali podtočka namenjena samo obravnavi ELEKTROMEDICINSKE OPREME ali ELEKTROMEDICINSKIH SISTEMOV, bo to zapisano v naslovu in vsebini točke ali podtočke. Če ni zapisano, točka ali podtočka obravnava ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME.

General Information

• Status: Published
• Publication Date: 04-Jun-2015
• Withdrawal Date: 13-Apr-2018
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62C - IEC_SC_62C
• Parallel Committee: IEC/SC 62C - IEC_SC_62C
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 05-Jun-2015
• Completion Date: 05-Jun-2015
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 60601-2-8:2015 - Medical electrical equipment - Part 2-8: Particular requirements for basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV

Relations

• Replaces: 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
• Effective Date: 28-Jan-2023
• Replaces: 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: 28-Jan-2023
• Amended By: EN 60601-2-8:2015/A1:2016 - 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: 06-Aug-2014

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2015
1DGRPHãþD
SIST EN 60601-2-8:1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLWHUDSHYWVNHUHQWJHQVNHRSUHPHNLGHOXMHYREPRþMXRGN9
GR09
Medical electrical equipment - Part 2-8: Particular requirements for basic safety and
essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1
MV
Medizinische elektrische Geräte - Teil 2-8: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Therapie-Röntgeneinrichtungen
im Bereich von 10 kV bis 1 MV
Appareils électromédicaux - Partie 2-8: Exigences particulières pour la sécurité de base
et les performances essentielles des équipements à rayonnement X de thérapie
fonctionnant dans la gamme de 10 kV à 1 MV
Ta slovenski standard je istoveten z: EN 60601-2-8:2015
ICS:
11.040.50 Radiografska oprema Radiographic equipment
13.280 Varstvo pred sevanjem Radiation protection
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60601-2-8

NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2015
ICS 11.040.50 Supersedes EN 60601-2-8:1997
English Version
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
(IEC 60601-2-8:2010)
Appareils électromédicaux - Partie 2-8: Exigences Medizinische elektrische Geräte - Teil 2-8: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des équipements à rayonnement X de thérapie wesentlichen Leistungsmerkmale von Therapie-
fonctionnant dans la gamme de 10 kV à 1 MV Röntgeneinrichtungen im Bereich von 10 kV bis 1 MV
(IEC 60601-2-8:2010) (IEC 60601-2-8:2010)
This European Standard was approved by CENELEC on 2015-04-14. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-8:2015 E
Foreword
The text of document 62C/499/FDIS, future edition 2 of IEC 60601-2-8, prepared by SC 62C, "Equipment
for radiotherapy, nuclear medicine and radiation dosimetry", of IEC TC 62, "Electrical equipment in
medical practice", was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as
The following dates are fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2016-01-14
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2018-04-14
This document supersedes EN 60601-2-8:1997.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patent
rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).

For the relationship with EU Directive see informative Annex ZZ, which is an integral part of this
document.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-8:2010 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following note has to be added for the standard indicated:
IEC 60601-2-17 NOTE  Harmonized as EN 60601-2-17.
__________
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.

NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu.
Annex ZA of EN 60601-1:2006 applies with the following exceptions:
Publication Year Title EN/HD Year
Addition:
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
IEC 60601-2-1 2009 Medical electrical equipment - - -
Part 2-1: Particular requirements for the basic
safety and essential performance of electron
accelerators in the range 1 MeV to 50 MeV

IEC 61217 - Radiotherapy equipment - Coordinates, EN 61217 -
movements and scales
ISO/IEC Guide 98-3 2008 Uncertainty of measurement - - -
Part 3: Guide to the expression of uncertainty
in measurement (GUM:1995)
Annex ZZ
(informative)
Coverage of Essential Requirements of EU Directives

This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and within its scope the Standard covers all
relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993 concerning
medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
NOTE Presumption of conformity with Essential Requirements 13.1 to 13.6 should depend on the
manufacturer confirming the accuracy of the accompanying documents in all relevant languages.
WARNING: Other requirements and other EU Directives can be applied to the products falling within the
scope of this standard.
IEC 60601-2-8 ®
Edition 2.0 2010-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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

Appareils électromédicaux –
Partie 2-8: Exigences particulières pour la sécurité de base et les performances
essentielles des équipements à rayonnement X de thérapie fonctionnant dans la
gamme de 10 kV à 1 MV
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
W
CODE PRIX
ICS 11.040.50 ISBN 978-2-88912-238-7
– 2 – 60601-2-8 Ó IEC:2010
CONTENTS
FOREW ORD . 3
INTRODUCTION . 5
201.1 Scope, object and related standards . 6
201.2 Normative references . 7
201.3 Terms and definitions . 8
201.4 General requirements . 8
201.5 General requirements for testing of ME EQUIPMENT . 9
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 11
201.7 ME EQUIPMENT identification, marking and documents . 11
201.8 Protection against electrical HAZARDS from ME EQUIPMENT. 14
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 15
201.10 Protection against unwanted and excessive radiation HAZARDS . 15
201.11 Protection against excessive temperatures and other HAZARDS . 30
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 30
201.13 HAZARDOUS SITUATIONS and fault conditions . 30
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS ) . 31
201.15 Construction of ME EQUIPMENT . 31
201.16 ME SYSTEMS . 31
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 31
Bibliography . 32
Index of defined terms used in this particular standard . 33

Table 201.101 – Data required in the technical description to support Clause 201.10
SITE and TYPE TEST compliance . 10
Table 201.102 – Permissible LEAKAGE RADIATION . 16
Table 201.103 – Permissible LEAKAGE RADIATION from X-RAY TUBE ASSEMBLIES with
BEAM LIMITING DEVICES . 18
Table 201.104 – Overview of measurements . 29

60601-2-8 Ó IEC:2010 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
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
FOREWORD
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