EN 62570:2015
(Main)Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
IEC 62570:2014 applies to the practice of marking of items that might be used in the magnetic resonance (MR) environment. The purpose of this practice is to mark items that might be brought into the MR environment and to recommend information that should be included in the marking. The standard specifies the permanent marking of items, which are used in an MR environment, by means of terms and icons. MR image artifacts are not considered to be a performance issue and so are not addressed in this international standard practice. IEC 62570 is integrating the unmodified text of ASTM F2503-13. It has been developed by subcommittee 62B: Diagnostic imaging equipment, of IEC technical committee 62: Medical equipment in medical practice, in collaboration with ASTM.
Standardverfahren für die Kennzeichnung medizinischer Geräte und anderer Gegenstände zur Sicherheit in der Umgebung von Magnetresonanzeinrichtungen
Pratiques normalisées relatives au marquage des appareils médicaux et des éléments de sûreté divers dédiés aux environnements de résonance magnétique
L'IEC 62570:2014 s'applique aux pratiques de marquage des éléments qui pourraient être utilisés dans des environnements de résonance magnétique (RM). L'objectif de cette pratique est de marquer les éléments qui peuvent ne pas être installés dans un environnement de RM, mais aussi d'indiquer les informations qu'il convient d'intégrer au marquage. La norme spécifie le marquage permanent des éléments utilisés dans un environnement de RM via des termes et symboles. Les artefacts d'image à RM ne constituent pas un problème de performance et ne sont donc pas abordés dans cette pratique internationale normalisée. Les valeurs indiquées dans des unités SI doivent être considérées comme normalisées. Aucune autre unité de mesure n'est utilisée dans cette norme. L'IEC 62570 comprend le texte non modifié de la ASTM F2503-13. Elle a été établie par le sous-comité 62B: Appareils d'imagerie de diagnostic, du comité d'études 62 de l'IEC: Equipements électriques dans la pratique médicale, en collaboration avec la ASTM.
Oprema z magnetno resonanco za medicinsko slikanje - Navodila za označevanje predmetov znotraj nadzorovanega območja
Ta standard se nanaša na prakso označevanja predmetov, ki bi se lahko uporabljali v okolju magnetne resonance (MR). Namen te prakse je označevanje predmetov, ki bi se lahko vnesli v okolje MR, in priporočiti informacije, ki bi jih bilo smiselno vključiti v oznako. Standard določa trajno označevanje predmetov, ki se uporabljajo v okolju MR, in sicer z izrazi in ikonami. Artefakti pri slikah v okviru MR se ne štejejo za težavo pri delovanju, zato niso obravnavani v praksi tega mednarodnega standarda (glej točko X1.5). Vrednosti, podane v enotah SI, se štejejo za standard. V tem standardu niso vključene druge merilne enote. Ta standard ne obravnava vseh morebitnih varnostnih težav, ki se nanašajo na njegovo uporabo. Za vzpostavitev ustreznih varnostnih in zdravstvenih praks ter za določitev uporabnosti regulativnih omejitev pred uporabo je odgovoren uporabnik tega standarda.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 62570:2015
01-september-2015
2SUHPD]PDJQHWQRUHVRQDQFR]DPHGLFLQVNRVOLNDQMH1DYRGLOD]DR]QDþHYDQMH
SUHGPHWRY]QRWUDMQDG]RURYDQHJDREPRþMD
Magnetic resonance equipment for medical imaging - Instructions for marking items
within the controlled access area
Standardverfahren für die Kennzeichnung medizinischer Geräte und anderer
Gegenstände zur Sicherheit in der Umgebung von Magnetresonanzeinrichtungen
Appareils à résonance magnétique utilisés pour l'imagerie médicale - Instructions pour le
marquage des éléments à l'intérieur de la zone à accès contrôlé
Ta slovenski standard je istoveten z: EN 62570:2015
ICS:
11.040.50 Radiografska oprema Radiographic equipment
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
SIST EN 62570:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 62570:2015
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SIST EN 62570:2015
EUROPEAN STANDARD EN 62570
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2015
ICS 11.040.50; 11.040.55
English Version
Standard practice for marking medical devices and other items
for safety in the magnetic resonance environment
(IEC 62570:2014)
Pratiques normalisées relatives au marquage des appareils Standardverfahren für die Kennzeichnung medizinischer
médicaux et des éléments de sûreté divers dédiés aux Geräte und anderer Gegenstände zur Sicherheit in der
environnements de résonance magnétique Umgebung von Magnetresonanzeinrichtungen
(IEC 62570:2014) (IEC 62570:2014)
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 62570:2015 E
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SIST EN 62570:2015
EN 62570:2015
Foreword
The text of document 62B/933/FDIS, future edition 1 of IEC 62570, 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 62570:2015.
The following dates are fixed:
(dop) 2016-01-14
• latest date by which the document has to be implemented at
national level by publication of an identical national
standard or by endorsement
(dow) 2018-04-14
• 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).
For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part
of this document.
Endorsement notice
The text of the International Standard IEC 62570:2014 was approved by CENELEC as a European
Standard without any modification.
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SIST EN 62570:2015
EN 62570:2015
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
...
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