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/A2:2024 - 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
01-maj-2011
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SIST EN 60601-2-45:2002
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
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.
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 to be withdrawn
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller
type. Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR
STANDARD OR AS NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all
subdivisions (e.g., Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g., 7.1, 7.2 and 7.2.1 are all subclauses of
Clause 7).
References to clauses within this standard are preceded by the term “clause” followed by the clause
number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” , so a statement is true if any combination
of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives,
Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
– “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or test.

- 3 - EN 60601-2-45:2011
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that
there is guidance or rationale related to that item in Annex AA.
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive MDD (93/423/EEC). See Annex ZZ.
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-45:2011 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
IEC 60601-2-7:1998 NOTE  Harmonized as EN 60601-2-7:1998 (not modified).
IEC 60601-2-28:2010 NOTE  Harmonized as EN 60601-2-28:2010 (not modified).
IEC 60601-2-32:1994 NOTE  Harmonized as EN 60601-2-32:1994 (not modified).
IEC 60664-1:2007 NOTE  Harmonized as EN 60664-1:2007 (not modified).
ISO 4090:2001 NOTE  Harmonized as EN ISO 4090:2004 (not modified).
ISO 12052 NOTE  Harmonized as EN ISO 12052 (not modified).
__________
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

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

NOTE  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Annex ZA of EN 60601-1:2006 applies, except as follows:

Publication Year Title EN/HD Year

Replace IEC 60601-1-2 and IEC 60601-1-3 by:

IEC 60601-1-2 2007 Medical electrical equipment - EN 60601-1-2 2007
(mod) Part 1-2: General requirements for basic + corr. March 2010
safety and essential performance - Collateral
standard: Electromagnetic compatibility -
Requirements and tests
IEC 60601-1-3 2008 Medical electrical equipment - EN 60601-1-3 2008
Part 1-3: General requirements for basic + corr. March 2010
safety and essential performance - Collateral
Standard: Radiation protection in diagnostic
X-ray equipment
Add:
IEC 60336 2005 Medical electrical equipment - X-ray tube EN 60336 2005
assemblies for medical diagnosis -
Characteristics of focal spots

IEC 60613 2010 Electrical and loading characteristics of X-ray EN 60613 2010
tube assemblies for medical diagnosis

IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
IEC 61223-3-2 2007 Evaluation and routine testing in medical EN 61223-3-2 2008
imaging departments -
Part 3-2: Acceptance tests - Imaging
performance of mammographic X-ray
equipment
IEC 62220-1-2 2007 Medical electrical equipment - Characteristics EN 62220-1-2 2007
of digital X-ray imaging devices -
Part 1-2: Determination of the detective
quantum efficiency - Detectors use in
mammography
ISO 9236-3 1999 Photography - Sensitometry of screen/film - -
systems for medical radiography -
Part 3: Determination of sensitometric curve
shape, speed and average gradient for
mammography
- 5 - EN 60601-2-45:2011
Annex ZZ
(informative)
Coverage of Essential Requirements of EC 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 as given in Annex I of the EC Directive 93/42/EEC.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.
IEC 60601-2-45 ®
Edition 3.0 2011-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-45: Particular requirements for the basic safety and essential performance
of mammographic X-ray equipment and mammographic stereotactic devices

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

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XA
ICS 11.040.50 ISBN 978-2-88912-347-6

– 2 – 60601-2-45  IEC:2011
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions. 10
201.4 General requirements . 11
201.5 General requirements for testing of ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents . 12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 16
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 19
201.10 Protection against unwanted and excessive radiation HAZARDS . 21
201.11 Protection against excessive temperatures and other HAZARDS . 22
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 22
201.13 Hazardous situations and fault conditions . 22
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 22
201.15 Construction of ME EQUIPMENT . 22
201.16 ME SYSTEMS . 22
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 23
202 Electromagnetic compatibility – Requirements and tests . 23
203 Radiation protection in diagnostic X-ray equipment . 23
Annex AA (informative) Particular guidance and rationale . 46
Bibliography . 48
Index of defined terms used in this particular standard. 49

Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 11
Table 203.101 – Minimum values of TOTAL FILTRATION and factors for det
...