EN 60601-2-45:2011

Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices

IEC 60601-2-45:2011 applies to the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices. IEC 60601-2-45:2011 addresses the system level of mammographic X-ray equipment, which consists of a combination of an X-ray generator, associated equipment and accessories. Components functions are addressed as far as necessary. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of mammographic X-ray equipment. Like the previous edition of this Part 2-45, the present third edition includes requirements on high-voltage generators for mammography. This third edition cancels and replaces the second edition published in 2001. This edition constitutes a technical revision. The document has been aligned to the 3rd edition of IEC 60601-1 (2005) and to IEC 60601-1-3 (2010). Further modifications have been made with respect to the current technology of mammographic X-ray equipment.

Medizinische elektrische Geräte - Teil 2-45: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Röntgen-Mammographiegeräten und mammographischen Stereotaxie-Einrichtungen

Appareils électromédicaux - Partie 2-45: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de mammographie à rayonnement X et des appareils mammographiques stéréotaxiques

La CEI 60601-2-45:2011 s'applique à la sécurité de base et aux performances essentielles des appareils de mammographie à rayonnement X et des appareils mammographiques stéréotaxiques. La CEI 60601-2-45:2011 traite du niveau système de l'appareil de mammographie à rayonnement X, qui se compose de la combinaison d'un groupe radiogène, d'appareils associés et d'accessoires. Les fonctions des composants sont abordées pour autant que nécessaire. Les exigences minimales de sécurité spécifiées dans la présente norme particulière sont considérées comme assurant un degré pratique de sécurité dans le fonctionnement des appareils de mammographie à rayonnement X. La précédente édition de la présente Partie 2-45 comprenait les exigences relatives aux générateurs radiologiques pour mammographie, il en est de même pour la présente 3ème édition. Cette troisième édition annule et remplace la deuxième édition publiée en 2001 dont elle constitue une révision technique. Ce document a été aligné sur la 3ème édition de la CEI 60601-1 (2005) et sur la CEI 60601-1-3 (2010). Des modifications supplémentaires ont été apportées, tenant compte de la technologie actuelle des appareils de mammographie à rayonnement X.

Medicinska električna oprema - 2-45. del: Posebne zahteve za osnovno varnost in bistvene lastnosti rentgenske opreme za mamografijo in stereotaktičnih naprav za mamografijo (IEC 60601-2-45:2011)

Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI
RENTGENSKE OPREME za MAMOGRAFIJO in STEREOTAKTIČNIH NAPRAV za MAMOGRAFIJO, v nadaljevanju ME OPREMO.
OPOMBA 1: To vključuje RENTGENSKO OPREMO za MAMOGRAFIJO, ki uporablja vgrajene digitalne SPREJEMNIKE RENTGENSKE SLIKE ali vgrajene podsisteme za shranjevanje fosforja.
S področja uporabe tega standarda so izvzeti:
- načini delovanja rekonstruktivne tomografije;
- konzole za diagnostiko;
- sistemi za hranjenje slik in komunikacijo (PACS);
- nevgrajeni bralniki za shranjevanje fosforja;
- kamere za izpis v tiskani obliki;
- filmi, zasloni in kasete;
- zaznava z računalnikom (CAD);
- naprave za opravljanje biopsije z debelo iglo in drugi instrumenti za biopsijo;
- načini delovanja, namenjeni za prikaz sprejema lokalnega kontrastnega medija (s kontrastom
izboljšana digitalna mamografija);
Če je klavzula ali podklavzula izrecno namenjena samo uporabi za ME OPREMO ali samo za ME SISTEME, bosta naslov in vsebina te klavzule ali podklavzule to tudi navedla. Sicer klavzula in podklavzula veljata za ustrezno ME OPREMO in ME SISTEME.
OPOMBA 2: IRC 60601-2-7:1998 in IEC 60601-2-32 niso del tretje izdaje shem za RENTGENSKO OPREMO ZA MAMOGRAFIJO in ZA STEREOTAKTIČNE NAPRAVE za MAMOGRAFIJO.

General Information

• Status: Published
• Publication Date: 17-Mar-2011
• ICS: 11.040.50 - Radiographic equipment
• ICS: 11.040.60 - Therapy 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: 9093 - Decision to confirm - Review Enquiry
• Start Date: 21-Aug-2024
• 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 60601-2-45:2011 - Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices (IEC 60601-2-45:2011)

Relations

• Replaces: EN 60601-2-45:2001 - Medical electrical equipment - Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices
• Effective Date: 28-Jan-2023
• Amended By: EN 60601-2-45:2011/A1:2015 - Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
• Effective Date: 28-Jan-2023
• Amended By: EN 60601-2-45:2011/prA2:2022 - Amendment 2 - Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
• Effective Date: 09-Dec-2021

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-45:2011
01-maj-2011
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SIST EN 60601-2-45:2002
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLUHQWJHQVNHRSUHPH]DPDPRJUDILMRLQVWHUHRWDNWLþQLKQDSUDY]D
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Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and
essential performance of mammographic X-ray equipment and mammographic
stereotactic devices (IEC 60601-2-45:2011)
Medizinische elektrische Geräte - Teil 2-45: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Röntgen-
Mammographiegeräten und mammographischen Stereotaxie- Einrichtungen (IEC 60601-
2-45:2011)
Appareils électromédicaux - Partie 2-45: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de mammographie à rayonnement X et
des appareils mammographiques stéréotaxiques (CEI 60601-2-45:2011)
Ta slovenski standard je istoveten z: EN 60601-2-45:2011
ICS:
11.040.50 Radiografska oprema Radiographic equipment
13.280 Varstvo pred sevanjem Radiation protection
SIST EN 60601-2-45:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-45:2011

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SIST EN 60601-2-45:2011

EUROPEAN STANDARD
EN 60601-2-45

NORME EUROPÉENNE
March 2011
EUROPÄISCHE NORM

ICS 11.040.50 Supersedes EN 60601-2-45:2001


English version


Medical electrical equipment -
Part 2-45: Particular requirements for the basic safety and essential
performance of mammographic X-ray equipment and mammographic
stereotactic devices
(IEC 60601-2-45:2011)


Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-45: Exigences particulières pour Teil 2-45: Besondere Festlegungen für die
la sécurité de base et les performances Sicherheit einschließlich der wesentlichen
essentielles des appareils de Leistungsmerkmale von Röntgen-
mammographie à rayonnement X et des Mammographiegeräten und
appareils mammographiques mammographischen Stereotaxie-
stéréotaxiques Einrichtungen
(CEI 60601-2-45:2011) (IEC 60601-2-45:2011)




This European Standard was approved by CENELEC on 2011-03-17. 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, Croatia, 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

Management Centre: Avenue Marnix 17, B - 1000 Brussels


© 2011 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-45:2011 E

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SIST EN 60601-2-45:2011
EN 60601-2-45:2011 - 2 -
Foreword
The text of document 62B/817/FDIS, future edition 3 of IEC 60601-2-45, 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 60601-2-45 on 2011-03-17.
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 European Standard supersedes EN 60601-2-45:2001.
EN 60601-2-45:2011 has been aligned to EN 60601-1:2006 and to EN 60601-1-3:2008 + corrigendum
March 2010. Further modifications have been made with respect to the current technology of
MAMMOGRAPHIC X-RAY EQUIPMENT.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
(dop) 2011-12-17
national standard or by endorsement
– latest date by which the national standards conflicting
(dow) 2014-03-17
with the EN have t
...