Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

This collateral standard applies to X-ray equipment and to subassemblies of such equipment, where radiological images of a human patient are used for diagnosis, planning or guidance of medical procedures. The object of this collateral standard is to establish general requirements for protection against X-radiation in X-ray equipment, in order that the irradiation of the human patient, the operator, staff and members of the public can be kept as low as reasonably achievable, without jeopardizing the benefit of the radiological procedure. Particular standards may specify their appropriate values and/or measures for general requirements specified in this collateral standard. The implementation of the general requirements or the reference to the particular standard instead, shall be justified in the risk management process. This collateral standard considers radiation protection aspects related to X-radiation only. Requirements for the control of the electrical energy used to generate X-radiation, which is also an important aspect of radiation protection, are included in IEC 60601-1 and in particular standards for the safety and essential performance of the equipment concerned. This document cancels and replaces the first edition of IEC 60601-1-3, published in 1994 (which replaced IEC 407 issued in 1973). It constitutes a technical revision. This edition has been restructured and aligned to IEC 60601-1(2005) and focussed on general requirements for RADIATION PROTECTION that apply to all diagnostic X-RAY EQUIPMENT. Requirements particular to specific equipment have been removed and will be covered in particular standards. For a description of the changes, see the mapping in Annex C.

Medizinische elektrische Geräte - Teil 1-3: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Strahlenschutz von diagnostischen Röntgengeräten

Appareils électromédicaux - Partie 1-3: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Radioprotection dans les appareils à rayonnement X de diagnostic

La présente norme collatérale s'applique aux appareils à rayonnement X et à leurs sous-ensembles, dont les images radiologiques d'un patient humain sont utilisées à des fins de diagnostic, de planification ou de guide pour les procédures médicales. L'objet de la présente norme collatérale est d'établir des exigences générales pour la protection contre les rayonnements X dans les appareils à rayonnement X, afin que l'irradiation des patients humains, de l'opérateur, des membres de l'équipe médicale et des autres personnes présentes puisse être maintenue à un niveau aussi bas que raisonnablement possible, sans compromettre le bénéfice de la procédure radiologique. Des normes particulières peuvent spécifier des valeurs et/ou mesures qui leur sont appropriées par rapport aux exigences générales spécifiées dans la présente norme collatérale. La mise en uvre des exigences générales ou, à la place, la référence à la norme particulière doit être justifiée dans le processus de gestion des risques. La présente norme collatérale traite des aspects de radioprotection liés aux rayonnements X uniquement. Les exigences pour la commande de l'énergie électrique utilisée pour produire le rayonnement X, qui est aussi un aspect important de la radioprotection, figurent dans la CEI 60601-1 et dans les normes particulières pour la sécurité et les performances essentielles des appareils concernés. Ce document annule et remplace la première édition de la CEI 60601-1-3, publiée en 1994 (qui a remplacé la CEI 407 publiée en 1973). Elle constitue une révision technique. La présente édition a été restructurée et alignée avec la CEI 60601-1 (2005) et traite des exigences générales pour la radioprotection qui s'appliquent à tous les appareils à rayonnement X de diagnostic. Les exigences particulières pour des appareils spécifiques ont été enlevées et seront couvertes dans des normes particulières. Pour une description des modifications, voir la correspondance présentée à l'Annexe C.

Medicinska električna oprema - 1-3. del: Splošne zahteve za osnovno varnost in bistvene lastnosti - Spremljevalni standard: Varstvo pred sevanjem pri rentgenski diagnostični opremi (IEC 60601-1-3:2008)

Ta mednarodni standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI MEDICINSKE ELEKTRIČNE OPREME in MEDICINSKIH ELEKTRIČNIH SISTEMOV (v nadaljevanju tudi: ELEKTROMEDICINSKA OPREMA in ELEKTROMEDICINSKI SISTEM). Ta spremljevalni standard se uporablja za RENTGENSKO OPREMO in podsestave tovrstne opreme,
kadar se RADIOLOŠKE SLIKE človeških PACIENTOV uporabljajo za diagnosticiranje, načrtovanje ali usmerjanje medicinskih postopkov.

General Information

Status
Published
Publication Date
23-Apr-2008
Withdrawal Date
31-May-2012
Current Stage
6060 - Document made available - Publishing
Start Date
24-Apr-2008
Completion Date
24-Apr-2008

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-1-3:2008
01-julij-2008
1DGRPHãþD
SIST EN 60601-1-3:1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO6SORãQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWL6SUHPOMHYDOQLVWDQGDUG9DUVWYRSUHGVHYDQMHPSULUHQWJHQVNL
GLDJQRVWLþQLRSUHPL ,(&
Medical electrical equipment - Part 1-3: General requirements for basic safety and
essential performance - Collateral Standard: Radiation protection in diagnostic X-ray
equipment (IEC 60601-1-3:2008)
Medizinische elektrische Geräte - Teil 1-3: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Strahlenschutz
von diagnostischen Röntgengeräten (IEC 60601-1-3:2008)
Appareils électromédicaux - Partie 1-3: Exigences générales pour la sécurité de base et
les performances essentielles - Norme collatérale: Radioprotection dans les appareils a
rayonnement X de diagnostic (CEI 60601-1-3:2008)
Ta slovenski standard je istoveten z: EN 60601-1-3:2008
ICS:
11.040.50 Radiografska oprema Radiographic equipment
13.280 Varstvo pred sevanjem Radiation protection
SIST EN 60601-1-3:2008 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

EUROPEAN STANDARD
EN 60601-1-3

NORME EUROPÉENNE
April 2008
EUROPÄISCHE NORM

ICS 11.040.50; 13.280 Supersedes EN 60601-1-3:1994


English version


Medical electrical equipment -
Part 1-3: General requirements for basic safety
and essential performance -
Collateral Standard: Radiation protection in diagnostic X-ray equipment
(IEC 60601-1-3:2008)


Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 1-3: Exigences générales Teil 1-3: Allgemeine Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles - der wesentlichen Leistungsmerkmale -
Norme collatérale: Radioprotection Ergänzungsnorm: Strahlenschutz
dans les appareils à rayonnement X von diagnostischen Röntgengeräten
de diagnostic (IEC 60601-1-3:2008)
(CEI 60601-1-3:2008)




This European Standard was approved by CENELEC on 2008-03-01. 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 Central Secretariat 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 Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels


© 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-1-3:2008 E

---------------------- Page: 2 ----------------------

EN 60601-1-3:2008 - 2 -
Foreword
The text of document 62B/673/FDIS, future edition 2 of IEC 60601-1-3, prepared by SC 62B, Diagnostic
imaging equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the
IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-1-3 on 2008-03-01.
The following date was fixed:

– latest date by which the EN has to be implemented

at national level by publication of an identical
(dop) 2008-12-01
national standard or by endorsement
This European Standard supersedes EN 60601-1-3:1994. However, EN 60601-1-3:1994 remains valid
until all the Parts 2 that are used in conjunction with it have been withdrawn. No date of withdrawal of
conflicting national standards (dow) has therefore been fixed. However, when Part 1-3 is used for
appliances not covered by a Part 2, EN 60601-1-3:1994 is not to be used after 2009-09-12.
This EN 60601-1-3 has been restructured and aligned to EN 60601-1:2006 and focussed on general
requirements for RADIATION PROTECTION that apply to all diagnostic X-RAY EQUIPMENT. Requirements
particular to specific equipment have been removed and will be covered in particular standards. For a
description of the changes, see the mapping in Annex C.
This European Standard has b
...

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