SIST EN 60601-2-45:2002

Medical electrical equipment - Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices (IEC 60601-2-45:2001)

Formulates appropriate design and manufacturing requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices, reflecting the particular characteristics and circumstances of use of such equipment. Establishes particular requirements to ensure safety and to specify methods for demonstrating compliance with those requirements. The safety requirements for the X-ray generator and its sub-assemblies form an integral part of this standard. Cancels and replaces the first edition published in 1998 and constitutes a technical revision.

Medizinische elektrische Geräte - Teil 2-45: Besondere Festlegungen für die Sicherheit von Röntgen-Mammographiegeräten und mammographischen Stereotaxie-Einrichtungen (IEC 60601-2-45:2001)

Appareils électromédicaux - Partie 2-45: Règles particulières de sécurité pour les appareils de radiographie mammaire et les appareils mammographiques stéréotaxiques (CEI 60601-2-45:2001)

La présente norme a pour objet: 1. de donner les exigences de conception et de fabrication appropriées pour la sécurité des équipements de mammographie à rayonnement x et des appareils de mammographie stéréotaxique, reflétant les caractéristiques et les circonstances particulières d'utilisation de ce type de matériel; 2. d'établir des exigences particulières pour assurer la sécurité et de spécifier des méthodes pour démontrer la conformité avec ces exigences. C'est la version bilingue de la version anglaise publiée en 2001.

Medicinska električna oprema - 2-45. del: Posebne varnostne zahteve za mamografsko rentgensko opremo in mamografske stereotaktične naprave (IEC 60601-2-45:2001)

General Information

• Status: Withdrawn
• Publication Date: 31-Oct-2002
• Withdrawal Date: 19-Apr-2016
• ICS: 11.040.50 - Radiographic equipment
• ICS: 13.280 - Radiation protection
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 19-Apr-2016
• Due Date: 12-May-2016
• Completion Date: 20-Apr-2016
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: 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

Relations

• Revised: 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)
• Effective Date: 25-Mar-2014
• Replaced By: 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)
• Effective Date: 28-Jan-2023
• Replaced By: 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)
• Effective Date: 17-Mar-2014

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-45:2002
01-november-2002
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQHYDUQRVWQH]DKWHYH]D
PDPRJUDIVNRUHQWJHQVNRRSUHPRLQPDPRJUDIVNHVWHUHRWDNWLþQHQDSUDYH,(&

Medical electrical equipment - Part 2-45: Particular requirements for the safety of
mammographic X-ray equipment and mammographic stereotactic devices (IEC 60601-2-
45:2001)
Medizinische elektrische Geräte - Teil 2-45: Besondere Festlegungen für die Sicherheit
von Röntgen-Mammographiegeräten und mammographischen Stereotaxie-Einrichtungen
(IEC 60601-2-45:2001)
Appareils électromédicaux - Partie 2-45: Règles particulières de sécurité pour les
appareils de radiographie mammaire et les appareils mammographiques stéréotaxiques
(CEI 60601-2-45:2001)
Ta slovenski standard je istoveten z: EN 60601-2-45:2001
ICS:
11.040.50 Radiografska oprema Radiographic equipment
13.280 Varstvo pred sevanjem Radiation protection
SIST EN 60601-2-45:2002 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

EUROPEAN STANDARD EN 60601-2-45
NORME EUROPÉENNE
EUROPÄISCHE NORM July 2001
ICS 11.040.50 Supersedes EN 60601-2-45:1998
English version
Medical electrical equipment
Part 2-45: Particular requirements for the safety of
mammographic X-ray equipment and
mammographic stereotactic devices
(IEC 60601-2-45:2001)
Appareils électromédicaux Medizinische elektrische Geräte
Partie 2-45: Règles particulières Teil 2-45: Besondere Festlegungen
de sécurité pour les appareils de für die Sicherheit von Röntgen-
radiographie mammaire et les appareils Mammographiegeräten und
mammographiques stéréotaxiques mammographischen Stereotaxie-
(CEI 60601-2-45:2001) Einrichtungen
(IEC 60601-2-45:2001)
This European Standard was approved by CENELEC on 2001-07-01. 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, Czech Republic,
Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway,
Portugal, Spain, Sweden, Switzerland and United Kingdom.
CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
Central Secretariat: rue de Stassart 35, B - 1050 Brussels
© 2001 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-45:2001 E

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EN 60601-2-45:2001 - 2 -
Foreword
The text of document 62B/427/FDIS, future edition 2 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 2001-07-01.
This European Standard supersedes EN 60601-2-45:1998.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2002-04-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2004-07-01
Annexes designated "normative" are part of the body of the standard.
Annexes designated "informative" are given for information only.
In this standard, annexes AA and CC are normative and annex BB is informative.
In this standard, the following print types are used:
– requirements, compliance with which can be tested, and definitions: roman type;
– explanations, advice, notes, general statements and exceptions: smaller roman type;
– test specifications and headings of subclauses: italic type;
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD, IN THIS STANDARD, IN IEC 60788 OR IN OTHER
IEC STANDARDS REFERENCED IN ANNEX AA: SMALL CAPITALS.
NOTE  Attention is drawn to the existence of legislation in some countries concerning RADIATION safety which may not align with
the provisions of this standard.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-45:2001 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 60417-2 NOTE  Harmonized as EN 60417-2:1998 (not modified).
IEC 60601-2-32 NOTE  Harmonized as EN 60601-2-32:1994(not modified).
IEC 60613 NOTE  Harmonized as EN 60613:1990 (not modified).
__________

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NORME CEI
INTERNATIONALE
IEC



60601-2-45
INTERNATIONAL


Deuxième édition
STANDARD

Second edition

2001-05


Appareils électromédicaux –
Partie 2-45:
Règles particulières de sécurité pour
les appareils de radiographie mammaire et les
appareils mammographiques stéréotaxiques

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

 IEC 2006 Droits de reproduction réservés  Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in any
utilisée sous quelque forme que ce soit et par aucun procédé, form or by any means, electronic or mechanical, including
électronique ou mécanique, y compris la photocopie et les photocopying and microfilm, without permission in writing from
microfilms, sans l'accord écrit de l'éditeur. the publisher.
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: [phone] Telefax: [phone] E-mail: [e-mail] Web: www.iec.ch
CODE PRIX
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PRICE CODE
Commission Electrotechnique Internationale
International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
Pour prix, voir catalogue en vigueur
For price, see current catalogue

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60601-2-45  IEC:2006 – 3 –
CONTENTS
FOREWORD.7

SECTION 1: GENERAL
1 Scope and object .11
1.1 Scope.11
1.2 Object.11
1.3 Particular standards.13
2 Terminology and definitions .15
2.101 Additional definitions.17
3 General requirements .19
5 Classification.19
6 Identification, marking and documents .19
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts .19
6.7 Indicator lights and push-buttons .23
6.8 ACCOMPANYING DOCUMENTS .23

SECTION 2: ENVIRONMENTAL CONDITIONS
10 Environmental conditions .29

SECTION 3: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
15 Limitation of voltage and/or energy.31
16 ENCLOSURES and PROTECTIVE COVERS .31
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS.31
19.3 Allowable values.31
20 Dielectric strength.33
20.3 Values of test voltages.33
20.4 Tests.35

SECTION 4: PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength.37
21.101 Application of maximum compression force .37
22 Moving parts.41
22.101 Motion of X-RAY TUBE – image receptor assembly.41
22.102 COMPRESSION DEVICE .41
22.103 MAMMOGRAPHIC STEREOTACTIC DEVICE .45
24 Stability in NORMAL USE.47

SECTION 5: PROTECTION AGAINST HAZARDS
FROM UNWANTED OR EXCESSIVE RADIATION
29 X-RADIATION.49
29.1 X-RADIATION generated by mammographic X-RAY EQUIPMENT .49

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60601-2-45  IEC:2006 – 5 –
29.207 PRIMARY PROTECTIVE SHIELDING .55
29.208 Protection against STRAY RADIATION.57
36 Electromagnetic compatibility.57

SECTION 6: PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES

SECTION 7: PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
42 Excessive temperatures.57

SECTION 8: ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data.59
50.1 General.59
50.101 Indication of electric and RADIATION output .59
50.102 Reproducibility, linearity and constancy.61
50.103 Accuracy of LOADING FACTORS .65
50.104 Test conditions.67
50.105 Conditions for measuring AIR KERMA.69
51 Protection against hazardous output .71

SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS

SECTION 10: CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly.71
56.7 Batteries.71
57 MAINS PARTS, components and layout.71
57.10 CREEPAGE DISTANCES and AIR CLEARANCES .73

Annex AA (normative) Terminology – Index of defined terms .77
Annex BB (informative) Rationale for allowing full IRRADIATION of mammograms .83
Annex CC (normative) Values of the series R'10 and R'20, ISO 497.85

Bibliography .87

Figure 101 – Example of a test device for MAMMOGRAPHIC STEREOTACTIC DEVICES .75

Table 101 – Tests for verifying reproducibility and linearity .71

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60601-2-45  IEC:2006 – 7 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
__________

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-45: Particular requirements for the safety 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 provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
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 second edition cancels and replaces the first edition published in 1998 and constitutes a
technical revision.

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60601-2-45  IEC:2006 – 9 –
This bilingual version (2006-02) replaces the English version.
The text of this Particular Standard is based on the following documents:
FDIS Report of voting
62B/427/FDIS 62B/438/RVD

The French version of this standard has not been voted upon.
Full information on the voting for the approval of this standard can be found in the report of
voting indicated in the above table.
In this standard, the following print types are used:
– requirements, compliance with which can be tested, and definitions: roman type;
explanations, advice, notes, general statements and exceptions: smaller roman type;
–
– test specifications and headings of subclauses: italic type;
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD, IN THIS STANDARD, IN IEC 60788 OR IN
OTHER IEC STANDARDS REFERENCED IN ANNEX AA: SMALL CAPITALS.
NOTE Attention is drawn to the existence of legislation in some countries concerning RADIATION safety which may
not align with the provisions of this standard.
The committee has decided that the contents of this publication will remain unchanged until the
maintenance result 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.

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60601-2-45  IEC:2006 – 11 –
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-45: Particular requirements for the safety of mammographic
X-ray equipment and mammographic stereotactic devices



SECTION 1: GENERAL
The clauses and subclauses of this section of the General Standard apply except as follows:
1 Scope and object
This clause of the General Standard applies except as follows:
1.1 Scope
Addition:
This Particular Standard contains requirements for the safety of X-RAY EQUIPMENT designed for
mammography and MAMMOGRAPHIC STEREOTACTIC DEVICES. The safety requirements for the
X-RAY GENERATOR and its sub-assemblies form an integral part of this standard.
1.2 Object
Replacement:
The object of this standard is
1 to formulate appropriate design and manufacturing requirements for the safety of
mammographic X-RAY EQUIPMENT and MAMMOGRAPHIC STEREOTACTIC DEVICES, reflecting the
particular characteristics and circumstances of use of such equipment;
2 to establish particular requirements to ensure safety and to specify methods for
demonstrating compliance with those requirements.
NOTE 1 Requirements for reproducibility, linearity, constancy and accuracy are given because of their relationship
to the quality and quantity of the IONIZING RADIATION produced and are confined to those considered necessary for
safety.
NOTE 2 Both the levels for compliance and the tests prescribed to determine compliance reflect the fact that the
safety of HIGH-VOLTAGE GENERATORS is not sensitive to small differences in levels of performance. The combinations
of LOADING FACTORS specified for the tests are therefore limited in number but chosen from experience as being
appropriate in most cases. It is considered important to standardize the choice of combinations of LOADING FACTORS
so that comparison can be made between tests performed in different places on different occasions. However,
combinations other than those specified could be of equal technical validity.
NOTE 3 The safety philosophy on which this standard is based is described in the introduction to the General
Standard and in IEC 60513.

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60601-2-45  IEC:2006 – 13 –
NOTE 4 Concerning RADIOLOGICAL PROTECTION it has been assumed in the preparation of this standard that
MANUFACTURERS and USERS do accept the general principles of the International Commission on Radiological
)
1
Protection (ICRP) as stated in ICRP 60, 1990, paragraph 112, namely:
"(a) No practice involving exposures to radiation should be adopted unless it produces sufficient benefit to the
exposed individuals or to society to offset the radiation detriment it causes. (The justification of a practice.)
(b) In relation to any particular source within a practice, the magnitude of individual doses, the number of people
exposed and the likelihood of incurring exposures where these are not certain to be received should all be kept as
low as reasonably achievable, economic and social factors being taken into account. This procedure should be
constrained by restrictions on the doses to individuals (dose constraints), or the risks to individuals in the case of
potential exposures (risk constraints), so as to limit the inequity likely to result from the inherent economic and
social judgements. (The optimisation of protection.)
(c) The exposure of individuals resulting from the combination of all the relevant practices should be subject to
dose limits, or to some control of risk in the case of potential exposures. These are aimed at ensuring that no
individual is exposed to radiation risks that are judged to be unacceptable from these practices in any normal
circumstances. Not all sources are susceptible of control by action at the source and it is necessary to specify the
sources to be included as relevant before selecting a dose limit. (Individual dose and risk limits.)"
NOTE 5 Most of the requirements on X-RAY EQUIPMENT and its sub-assemblies for protection against IONIZING
RADIATION are given in the Collateral Standard IEC 60601-1-3.
This standard does, however, deal with some aspects of RADIOLOGICAL PROTECTION, mainly those that depend upon
the supply, control and indication of electrical energy from the HIGH-VOLTAGE GENERATOR.
NOTE 6 It is recognized that many of the judgements necessary to follow the ICRP general principles have to be
made by the USER and not by the MANUFACTURER of the EQUIPMENT.
1.3 Particular standards
Addition:
This Particular Standard, hereinafter referred to as "this standard", amends and supplements a
set of IEC publications, hereinafter referred to as "General Standard", consisting of
IEC 60601-1: 1988, Medical electrical equipment – Part 1: General requirements for safety, its
amendments 1 (1991) and 2 (1995) and all Collateral Standards.
The numbering of sections, clauses and subclauses of this standard corresponds to that of the
General Standard. 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 is replaced
completely by the text of this standard.
"Addition" means that the text of this standard is additional to the requirements of the General
Standard.
"Amendment" means that the clause or subclause of the General Standard is amended as
indicated by the text of this standard.
Subclauses or figures which are additional to those of the General Standard are numbered
starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb),
etc.
___________
1)
ICRP Publication 60: Recommendations of the International Commission on Radiological Protection (Annals of
the ICRP Vol. 21 No 1-3, 1990). Published by Pergamon Press.

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60601-2-45  IEC:2006 – 15 –
Where there is no corresponding section, clause or subclause in this standard, the section,
clause or subclause of the General Standard applies without modification.
Where it is intended that any part of the General Standard, although possibly relevant, is not to
be applied, a statement to that effect is given in this standard.
A requirement of this standard replacing or modifying requirements of the General Standard
takes precedence over the original requirements concerned.
1.3.101 Related International Standards
IEC 60601-2-28:1993, Medical electrical equipment – Part 2: Particular requirements for the
safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
IEC 60664-1:1992, Insulation coordination for equipment within low-voltage systems – Part 1:
Principles, requirements and tests
IEC 60788:1984, Medical radiology – Terminology
IEC 61223-3-2:1996, Evaluation and routine testing in medical imaging departments – Part 3-2:
Acceptance tests – Imaging performance of mammographic X-RAY EQUIPMENT
ISO 497:1973, Guide to the choice of series of preferred numbers and of series containing
more rounded values of preferred numbers
2 Terminology and definitions
This clause of the General Standard applies except as follows:
Associated conditions qualifying the usage of certain terms are given in 2.102.
a) In this standard unless otherwise indicated:
– values of X-RAY TUBE VOLTAGE refer to peak values, transients being disregarded;
– values of X-RAY TUBE CURRENT refer to average values.
b) The electric power in the high-voltage circuit mentioned in 6.8.2 a) 3) and 6.8.2 a) 4) is
calculated according to the formula:
P = f U I
where
P is the electric power;
f is the factor depending on the waveform of the X-RAY TUBE VOLTAGE, selected as below and
is:
a) 0,95 for SIX-PEAK HIGH-VOLTAGE GENERATORS; or
b) 1,00 for TWELVE-PEAK HIGH-VOLTAGE GENERATORS and CONSTANT POTENTIAL high-voltage
generators; or
c) for other HIGH-VOLTAGE GENERATORS, the most appropriate value, 0,95 or 1,00, chosen
according to the waveform of the X-RAY TUBE VOLTAGE, with a statement of the value
selected;
U is the X-RAY TUBE VOLTAGE;
I is the X-RAY TUBE CURRENT.

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60601-2-45  IEC:2006 – 17 –
2.101 Additional definitions
In this standard, terms printed in SMALL CAPITALS are used in accordance with their definitions
either in the General Standard, in this standard, in IEC 60788 or in other IEC standards
referenced in annex AA.
NOTE Attention is drawn to the fact that, in cases where the concept addressed is not strongly confined to the
definition given in one of the publications listed above, a corresponding term is printed in lower case letters.
An index of defined terms used in this standard is given in annex AA.
For the purposes of this standard, the following additional definitions apply.
2.101.1 Not used.
2.101.2
MAMMOGRAPHIC STEREOTACTIC DEVICE
device for three-dimensional localization of a point within the breast, and for mechanically
guided placement of a needle or position marker for such purposes as fine-needle aspiration,
core biopsy and pre-surgical localization. The localization is based on radiographic images of
an immobilized breast acquired at different known angles. Such a device may be a dedicated
system or an ACCESSORY for mammographic X-RAY EQUIPMENT
2.101.3
CORE BIOPSY GUN
automatic needle device for performing core biopsy
2.101.4
DIRECT FOCAL DISTANCE
shortest distance from the X-RAY IMAGE RECEPTOR to the position of the FOCAL SPOT
2.102 Qualifying conditions for defined terms
2.102.1
operating conditions for NOMINAL X-RAY TUBE VOLTAGE
NOMINAL X-RAY TUBE VOLTAGE is defined in IEC 60788 (rm-36-03) as the highest permitted
X-RAY TUBE VOLTAGE for specific operating conditions. In this standard, if specific operating
conditions are not stated, it is to be assumed that the value referenced is unconditional and is
thus the highest X-RAY TUBE VOLTAGE permitted for NORMAL USE of the item under
consideration. Such a value cannot be higher, but is sometimes lower, than values permitted
for certain separate sub-assemblies or parts of the item
2.102.2
PERCENTAGE RIPPLE in CONSTANT POTENTIAL HIGH-VOLTAGE GENERATORS
Unless otherwise stated, it is to be assumed that for a HIGH-VOLTAGE GENERATOR to be
regarded as a CONSTANT POTENTIAL HIGH-VOLTAGE GENERATOR, the PERCENTAGE RIPPLE of its
output voltage (under the relevant conditions) does not exceed 4
2.102.3
RADIATION QUANTITY for NOMINAL SHORTEST IRRADIATION TIME
The definition of NOMINAL SHORTEST IRRADIATION TIME refers to a required constancy of a
RADIATION QUANTITY. In this standard the RADIATION QUANTITY concerned is AIR KERMA

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60601-2-45  IEC:2006 – 19 –
2.102.4
IRRADIATION TIME
Generally the IRRADIATION TIME is measured in terms of LOADING TIME as the time interval
between:
− the instant that the X-RAY TUBE VOLTAGE has risen for the first time to a value of 75 % of the
peak value; and
− the instant at which it finally drops below the same value
3 General requirements
This clause of the General
...