SIST EN 60601-1-3:2008/A1:2014

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

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. 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.

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

Medicinska električna oprema - 1-3. del: Splošne zahteve za osnovno varnost in bistvene lastnosti - Spremljevalni standard: Zaščita pred sevanjem pri rentgenski diagnostični opremi - Dopolnilo A1 (IEC 60601-1-3:2008/A1:2013)

Ta mednarodni standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI MEDICINSKE ELEKTRIČNE OPREME in MEDICINSKE ELEKTRIČNE SISTEME (v nadaljevanju tudi: ELEKTROMEDICINSKA OPREMA in ELEKTROMEDICINSKI SISTEMI). 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: 05-Jun-2014
• ICS: 11.040.50 - Radiographic equipment
• ICS: 13.280 - Radiation protection
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 19-May-2014
• Due Date: 24-Jul-2014
• Completion Date: 06-Jun-2014
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN 60601-1-3:2008/A1:2013 - Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

Relations

• Amends: SIST EN 60601-1-3:2008 - Medical electrical equipment -- Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
• Effective Date: 16-Oct-2012
• Amends: SIST EN 60601-1-3:2008 - Medical electrical equipment -- Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
• Effective Date: 29-Jan-2023
• Corrected By: SIST EN 60601-1-3:2008/A1:2014/AC:2014 - Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
• Effective Date: 29-Jan-2023
• Corrected By: SIST EN 60601-1-3:2008/A1:2014/AC:2014 - Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
• Effective Date: 24-Dec-2013

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-1-3:2008/A1:2014
01-julij-2014
0HGLFLQVNDHOHNWULþQDRSUHPDGHO6SORãQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWL6SUHPOMHYDOQLVWDQGDUG=DãþLWDSUHGVHYDQMHPSULUHQWJHQVNL
GLDJQRVWLþQLRSUHPL'RSROQLOR$,(&$
Medical electrical equipment - Part 1-3: General requirements for basic safety and
essential performance - Collateral Standard: Radiation protection in diagnostic X-ray
equipment
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
Ta slovenski standard je istoveten z: EN 60601-1-3:2008/A1:2013
ICS:
11.040.50 Radiografska oprema Radiographic equipment
13.280 Varstvo pred sevanjem Radiation protection
SIST EN 60601-1-3:2008/A1:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-1-3:2008/A1:2014

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SIST EN 60601-1-3:2008/A1:2014

EUROPEAN STANDARD
EN 60601-1-3/A1

NORME EUROPÉENNE
June 2013
EUROPÄISCHE NORM

ICS 11.040.50; 13.280


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/A1:2013)


Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 1-3: Exigences générales pour la Teil 1-3: Allgemeine Festlegungen für die
sécurité de base et les performances Sicherheit einschließlich der wesentlichen
essentielles - Leistungsmerkmale -
Norme collatérale: Radioprotection dans Ergänzungsnorm: Strahlenschutz von
les appareils à rayonnement X de diagnostischen Röntgengeräten
diagnostic (IEC 60601-1-3:2008/A1:2013)
(CEI 60601-1-3:2008/A1:2013)





This amendment A1 modifies the European Standard EN 60601-1-3:2008; it was approved by CENELEC on
2013-05-24. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which
stipulate the conditions for giving this amendment 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 amendment 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.

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

Management Centre: Avenue Marnix 17, B - 1000 Brussels


© 2013 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-1-3:2008/A1:2013 E

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SIST EN 60601-1-3:2008/A1:2014
EN 60601-1-3:2008/A1:2013 - 2 -

Foreword
The text of document 62B/895/CDV, future amendment 1 to 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 approved by CENELEC as
EN 60601-1-3:2008/A1:2013.

The following dates are fixed:
(dop) 2014-02-24
• latest date by which the document has
to be implemented at national level by
publication of an identical national
standard or by endorsement

(dow) 2016-05-24
• latest date by which the national
standards conflicting with the
document have to be withdrawn

Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] 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).

Endorsement notice
The text of the International Standard IEC 60601-1-3:2008/A1:2013 was approved by CENELEC as a
European Standard without any modification.

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