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
Current Stage
6060 - Document made available
Due Date
18-Mar-2011
Completion Date
18-Mar-2011

RELATIONS

Buy Standard

Standard
EN 60601-2-45:2011
English language
56 pages
sale 10% off
Preview
sale 10% off
Preview

e-Library read for
1 day

Standards Content (sample)

SLOVENSKI STANDARD
SIST EN 60601-2-45:2011
01-maj-2011
1DGRPHãþD
SIST EN 60601-2-45:2002
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLUHQWJHQVNHRSUHPH]DPDPRJUDILMRLQVWHUHRWDNWLþQLKQDSUDY]D
PDPRJUDILMR ,(&

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.

---------------------- Page: 1 ----------------------
SIST EN 60601-2-45:2011
---------------------- Page: 2 ----------------------
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
---------------------- Page: 3 ----------------------
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 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.

---------------------- Page: 4 ----------------------
SIST EN 60601-2-45:2011
- 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).
__________
---------------------- Page: 5 ----------------------
SIST EN 60601-2-45:2011
EN 60601-2-45:2011 - 4 -
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
---------------------- Page: 6 ----------------------
SIST EN 60601-2-45:2011
- 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.
---------------------- Page: 7 ----------------------
SIST EN 60601-2-45:2011
---------------------- Page: 8 ----------------------
SIST EN 60601-2-45:2011
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
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 9 ----------------------
SIST EN 60601-2-45:2011
– 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 determining the

minimum AIR KERMA RATE ...................................................................................................... 38

---------------------- Page: 10 ----------------------
SIST EN 60601-2-45:2011
60601-2-45  IEC:2011 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-45: Particular requirements for the basic safety and essential
performance of mammographic X-ray equipment
and mammographic stereotactic devices
FOREWORD

1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising

all national electrotechnical committees (IEC National Committees). The object of IEC is to promote

international co-operation on all questions concerning standardization in the electrical and electronic fields. To

this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,

Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC

Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested

in the subject dealt with may participate in this preparatory work. International, governmental and non-

governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely

with the International Organization for Standardization (ISO) in accordance with conditions determined by

agreement between the two organizations.

2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international

consensus of opinion on the relevant subjects since each technical committee has representation from all

interested IEC National Committees.

3) IEC Publications have the form of recommendations for international use and are accepted by IEC National

Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC

Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any

misinterpretation by any end user.

4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications

transparently to the maximum extent possible in their national and regional publications. Any divergence

between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in

the latter.

5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity

assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any

services carried out by independent certification bodies.

6) All users should ensure that they have the latest edition of this publication.

7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and

members of its technical committees and IEC National Committees for any personal injury, property damage or

other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and

expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC

Publications.

8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is

indispensable for the correct application of this publication.

9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of

patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

International standard IEC 60601-2-45 has been prepared by subcommittee 62B: Diagnostic

imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice.

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 3 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.
---------------------- Page: 11 ----------------------
SIST EN 60601-2-45:2011
– 4 – 60601-2-45  IEC:2011
The text of this particular standard is based on the following documents:
FDIS Report on voting
62B/817/FDIS 62B/821/RVD

Full information on the voting for the approval of this particular standard can be found in the

report on voting indicated in the above table.

This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

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.

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.

A list of all parts of the IEC 60601 series, published under the general title: Medical electrical

equipment, can be found on the IEC website
---------------------- Page: 12 ----------------------
SIST EN 60601-2-45:2011
60601-2-45  IEC:2011 – 5 –

The committee has decided that the contents of this publication will remain unchanged until

the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data

related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
---------------------- Page: 13 ----------------------
SIST EN 60601-2-45:2011
– 6 – 60601-2-45  IEC:2011
INTRODUCTION

The third edition of this particular standard has been prepared to provide a complete set of

safety requirements for MAMMOGRAPHIC X-RAY EQUIPMENT, based on IEC 60601-1:2005 (3

edition) and its collaterals. This particular standard 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.
---------------------- Page: 14 ----------------------
SIST EN 60601-2-45:2011
60601-2-45  IEC:2011 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-45: Particular requirements for the basic safety and essential
performance of mammographic X-ray equipment
and mammographic stereotactic devices
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:

This international standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of

MAMMOGRAPHIC X-RAY EQUIPMENT and MAMMOGRAPHIC STEREOTACTIC DEVICES, hereafter also

referred to as ME EQUIPMENT.

NOTE 1 This includes MAMMOGRAPHIC X-RAY EQUIPMENT using integrated digital X-RAY IMAGE RECEPTORS or

integrated storage phosphor subsystems.
Excluded from the scope of this document are:
– reconstructive tomography modes of operation;
– diagnostic consoles;
– picture archiving and communication systems (PACS);
– non-integrated storage phosphor readers;
– hard copy cameras;
– films, screens and cassettes;
– computer aided detection (CAD);
– devices for performing core biopsy and other biopsy instruments;

– modes of operation intended to demonstrate local contrast medium uptake (contrast

enhanced digital mammography);

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to

ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the

case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

NOTE 2 IEC 60601-2-7:1998 and IEC 60601-2-32 are not part of the 3 edition scheme for MAMMOGRAPHIC X-RAY

EQUIPMENT and MAMMOGRAPHIC STEREOTACTIC DEVICES.
201.1.2 Object
Replacement:

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL

PERFORMANCE requirements for MAMMOGRAPHIC X-RAY EQUIPMENT and MAMMOGRAPHIC

STEREOTACTIC DEVICES, to ensure safety, to specify methods for demonstrating compliance

with those requirements and to provide guidance for RISK MANAGEMENT.
___________

The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for

basic safety and essential performance.
---------------------- Page: 15 ----------------------
SIST EN 60601-2-45:2011
– 8 – 60601-2-45  IEC:2011
201.1.3 Collateral standards
Addition:

This particular standard refers to those applicable collateral standards that are listed in

Clause 2 of the general standard and Clause 201.2 of this particular standard.

IEC 60601-1-2:2007 and IEC 60601-1-3:2008 apply as modified in Clauses 202 and 203,

respectively. IEC 60601-1-8, IEC 60601-1-9, IEC 60601-1-10, and IEC 60601-1-11 do not

apply . All other published collateral standards in the IEC 60601-1-X series apply as

published.
201.1.4 Particular standards
Replacement:

In the IEC 60601 series, particular standards may modify, replace or delete requirements

contained in the general standard and collateral standards as appropriate for the particular

ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.

A requirement of a particular standard takes priority over the general standard or a collateral

standard.

For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.

Collateral standards are referred to by their document number.

The numbering of clauses and subclauses of this particular standard corresponds to that of

the general standard with the prefix “201” (e.g., 201.1 in this standard addresses the content

of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”

where x is the final digit(s) of the collateral standard document number (e.g., 202.4 in this

particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral

standard, 203.4 in this particular standard addresses the content of Clause 4 of the

IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are

specified by the use of the following words:

"Replacement" means that the clause or subclause of the general standard or applicable

collateral standard is replaced completely by the text of this particular standard.

"Addition" means that the text of this particular standard is additional to the requirements of

the general standard or applicable collateral standard.

"Amendment" means that the clause or subclause of the general standard or applicable

collateral standard is amended as indicated by the text of this particular standard.

Subclauses, figures or tables which are additional to those of the general standard are

numbered starting from 201.101. However, due to the fact that definitions in the general

standard are numbered 3.1 through 3.139, additional definitions in this standard are

numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and

additional items aa), bb), etc.
___________

IEC 60601-1-9:2007, Medical electrical equipment – Part 1-9: General requirements for basic safety and

essential performance – Collateral Standard: Requirements for environmentally conscious design.

IEC 60601-1-10:2007, Medical electrical equipment – Part 1-10: General requirements for basic safety and

essential performance – Collateral Standard: Requirements for the development of physiologic closed-loop

controllers. IEC 60601-1-11:2010, Medical electrical equipment – Part 1-11: General requirements for basic

safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and

medical electrical systems used in the home healthcare environment
---------------------- Page: 16 ----------------------
SIST EN 60601-2-45:2011
60601-2-45  IEC:2011 – 9 –

Subclauses, figures or tables which are additional to those of a collateral standard are

numbered starting from 20x, where “x” is the number of the collateral standard, e.g., 202 for

IEC 60601-1-2, 203 for IEC 60601-1-3, etc.

The term "this standard" is used to make reference to the general standard, any applicable

collateral standards and this particular standard taken together.

Where there is no corresponding, clause or subclause in this particular standard, the clause

or subclause of the general standard or applicable collateral standard, although possibly not

relevant, applies without modification; where it is intended that any part of the general

standard or applicable collateral standard, although possibly relevant, is not to be applied, a

statement to that effect is given in this particular standard.
201.2 Normative references
NOTE Informative references are listed in the bibliography beginning on page 48.
Clause 2 of the general standard applies, except as follows:
Replacement:

IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic

safety and essential performance – Colla
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.