IEC 60601-2-45:2001
(Main)Medical electrical equipment - Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices
Medical electrical equipment - Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices
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. It is the bilingual version of the english version published in 2001.
Appareils électromédicaux - Partie 2-45: Règles particulières de sécurité pour les appareils de radiographie mammaire et les appareils mammographiques stéréotaxiques
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.
General Information
Relations
Overview
IEC 60601-2-45:2001 is a Particular Standard of the IEC 60601 family that specifies safety requirements for mammographic X‑ray equipment and mammographic stereotactic devices. Published as the second edition in 2001 (bilingual English/French), it amends and supplements the IEC 60601‑1 General Standard to reflect the special characteristics and use conditions of mammography systems. The standard’s objective is to define design, manufacturing and testing requirements and methods to demonstrate compliance, with an emphasis on both electrical and radiological safety.
Key topics and technical requirements
The standard addresses device‑specific hazards and test methods while preserving the General Standard structure. Major technical topics include:
- Electrical safety and protection against electric shock
- Limits on leakage and patient auxiliary currents, dielectric strength and insulation requirements.
- Radiation protection and X‑radiation control
- Requirements linked to the high‑voltage generator, output indication and controls to limit unwanted or excessive X‑radiation.
- Accuracy of operating data
- Tests and requirements for reproducibility, linearity, constancy and accuracy of radiation output because of their direct relation to patient dose and image quality.
- Mechanical and thermal safety
- Mechanical strength, moving parts, stability in normal use and protection against excessive temperatures.
- Electromagnetic compatibility (EMC)
- Measures to ensure correct operation in clinical electromagnetic environments.
- Abnormal operation and fault conditions
- Tests and constructional requirements for safe behaviour during faults, including batteries and mains parts.
- Documentation, marking and indicators
- Clear user instructions, labeling, indicator lights and push‑button functions.
- Annexes
- Includes normative terminology (Annex AA), informative rationale (Annex BB) and technical data (Annex CC).
The standard references radiological protection principles from ICRP and indicates that many radiological protection specifics are covered in collateral standards.
Applications and who uses it
IEC 60601-2-45 is used by:
- Manufacturers of mammography units and stereotactic biopsy devices to design and validate compliant products.
- Test laboratories and certification bodies to assess conformity with electrical and radiological safety requirements.
- Regulatory authorities and hospital biomedical engineering teams for procurement, safety audits and acceptance testing.
- Clinical engineers and medical physicists tasked with commissioning, verification and routine quality assurance.
Related standards
- IEC 60601‑1: General requirements for basic safety and essential performance
- IEC 60601‑1‑3 (Collateral): Requirements related to radiation protection (referred to in this standard)
- IEC 60601‑2‑28: Related particular requirements (referenced)
- IEC 60513: Safety philosophy for radiological equipment
Keywords: IEC 60601‑2‑45, mammographic X‑ray equipment, mammographic stereotactic devices, medical electrical equipment, mammography safety, radiological protection, reproducibility, leakage current, dielectric strength, EMC.
Standards Content (Sample)
INTERNATIONAL IEC
STANDARD
60601-2-45
Second edition
2001-05
Medical electrical equipment –
Part 2-45:
Particular requirements for the safety of
mammographic X-ray equipment and
mammographic stereotactic devices
Appareils électromédicaux –
Partie 2-45:
Règles particulières de sécurité pour les appareils
de radiographie mammaire et les appareils
mammographiques stéréotaxiques
Reference number
Publication numbering
As from 1 January 1997 all IEC publications are issued with a designation in the
60000 series. For example, IEC 34-1 is now referred to as IEC 60034-1.
Consolidated editions
The IEC is now publishing consolidated versions of its publications. For example,
edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the base publication, the
base publication incorporating amendment 1 and the base publication incorporating
amendments 1 and 2.
Further information on IEC publications
The technical content of IEC publications is kept under constant review by the IEC,
thus ensuring that the content reflects current technology. Information relating to
this publication, including its validity, is available in the IEC Catalogue of
publications (see below) in addition to new editions, amendments and corrigenda.
Information on the subjects under consideration and work in progress undertaken
by the technical committee which has prepared this publication, as well as the list
of publications issued, is also available from the following:
• IEC Web Site (www.iec.ch)
• Catalogue of IEC publications
The on-line catalogue on the IEC web site (www.iec.ch/catlg-e.htm) enables
you to search by a variety of criteria including text searches, technical
committees and date of publication. On-line information is also available on
recently issued publications, withdrawn and replaced publications, as well as
corrigenda.
• IEC Just Published
This summary of recently issued publications (www.iec.ch/JP.htm) is also
available by email. Please contact the Customer Service Centre (see below) for
further information.
• Customer Service Centre
If you have any questions regarding this publication or need further assistance,
please contact the Customer Service Centre:
Email: custserv@iec.ch
Tel: +41 22 919 02 11
Fax: +41 22 919 03 00
INTERNATIONAL IEC
STANDARD
60601-2-45
Second edition
2001-05
Medical electrical equipment –
Part 2-45:
Particular requirements for the safety of
mammographic X-ray equipment and
mammographic stereotactic devices
Appareils électromédicaux –
Partie 2-45:
Règles particulières de sécurité pour les appareils
de radiographie mammaire et les appareils
mammographiques stéréotaxiques
IEC 2001 Copyright - all rights reserved
No part of this publication may be reproduced or utilized in any form or by any means, electronic or
mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: +41 22 919 0300 e-mail: inmail@iec.ch IEC web site http://www.iec.ch
Commission Electrotechnique Internationale
PRICE CODE
S
International Electrotechnical Commission
For price, see current catalogue
– 2 – 60601-2-45 IEC:2001(E)
CONTENTS
FOREWORD 4
..........................................................................................................................
SECTION 1: GENERAL
1 Scope and object 6
...............................................................................................................
1.1 Scope 6
.......................................................................................................................
1.2 Object 6
.......................................................................................................................
1.3 Particular Standards 7
.................................................................................................
2 Terminology and definitions 8
................................................................................................
3 General requirements 10
......................................................................................................
5 Classification 10
...................................................................................................................
6 Identification, marking and documents 10
..............................................................................
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts 10
.........................................
6.7 Indicator lights and push-buttons 11
.............................................................................
6.8 ACCOMPANYING DOCUMENTS 12
.....................................................................................
SECTION 2: ENVIRONMENTAL CONDITIONS
10 Environmental conditions 14
...............................................................................................
SECTION 3: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
15 Limitation of voltage and/or energy 15
..............................................................................
NCLOSURES PROTECTIVE COVERS
16 E and 16
..........................................................................
LEAKAGE CURRENTS PATIENT AUXILIARY CURRENTS
19 Continuous and 16
.................................
19.3 Allowable values 16
................................................................................................
20 Dielectric strength 17
.......................................................................................................
20.3 Values of test voltages 17
.......................................................................................
20.4 Tests 17
.................................................................................................................
SECTION 4: PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength 18
....................................................................................................
22 Moving parts 20
................................................................................................................
24 Stability in NORMAL USE 23
................................................................................................
SECTION 5: PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
29 X-RADIATION 24
.................................................................................................................
29.1 X-RADIATION generated by mammographic X-RAY EQUIPMENT 24
..............................
36 Electromagnetic compatibility 28
.......................................................................................
60601-2-45 IEC:2001(E) – 3 –
SECTION 6: PROTECTION AGAINST HAZARDS OF IGNITION OF
FLAMMABLE ANAESTHETIC MIXTURES
SECTION 7: PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
42 Excessive temperatures 28
..............................................................................................
SECTION 8: ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data 29
..........................................................................................
50.1 General 29
.........................................................................................................
50.101 Indication of electric and RADIATION output 29
......................................................
50.102 Reproducibility, linearity and constancy 30
..........................................................
LOADING FACTORS
50.103 Accuracy of 32
........................................................................
50.104 Test conditions 33
..............................................................................................
AIR KERMA
50.105 Conditions for measuring 34
...............................................................
51 Protection against hazardous output 34
............................................................................
SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
SECTION 10: CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly 35
.............................................................................
56.7 Batteries 35
............................................................................................................
57 MAINS PARTS, components and layout 35
...........................................................................
57.10 CREEPAGE DISTANCES and AIR CLEARANCES 35
........................................................
Annex AA (normative) Terminology – Index of defined terms 37
................................................
Annex BB (informative) Rationale for allowing full IRRADIATION of mammograms 40
...................
Annex CC (normative) Values of the series R´10 and R´20, ISO 497 41
....................................
Bibliography 42
.........................................................................................................................
Figure 101 – Example of a TEST DEVICE for MAMMOGRAPHIC STEREOTACTIC DEVICES 36
................
Table 101 – Tests for verifying reproducibility and linearity 34
....................................................
– 4 – 60601-2-45 IEC:2001(E)
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 IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of the 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, the IEC publishes International Standards. 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. The 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 the 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 National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical specifications, technical reports or guides and they are accepted by the National
Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. The 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.
The text of this Particular Standard is based on the following documents:
FDIS Report of voting
62B/427/FDIS 62B/438/RVD
Full information on the voting for the approval of this standard can be found in the report of
voting indicated in the above table.
Annexes AA and CC form an integral part of this standard.
Annex BB is for information only.
60601-2-45 IEC:2001(E) – 5 –
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
2004-06. At this date, the publication will be
reconfirmed;
•
withdrawn;
•
replaced by a revised edition, or
•
amended.
•
A bilingual version of this publication may be issued at a later date.
– 6 – 60601-2-45 IEC:2001(E)
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
RAY GENERATOR
X- 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.
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
)
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.)
___________
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.
60601-2-45 IEC:2001(E) – 7 –
(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.)"
RAY EQUIPMENT IONIZING
NOTE 5 Most of the requirements on X- and its sub-assemblies for protection against
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, , its
Medical electrical equipment – Part 1: General requirements for safety
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.
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.
– 8 – 60601-2-45 IEC:2001(E)
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;
RAY TUBE VOLTAGE
f is the factor depending on the waveform of the X- , 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
HIGH VOLTAGE GENERATORS
c) for other - , 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.
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.
60601-2-45 IEC:2001(E) – 9 –
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.
Not used.
2.101.1
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
RAY IMAGE RECEPTOR FOCAL SPOT
shortest distance from the X- to the position of the
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
NOMINAL SHORTEST IRRADIATION TIME
The definition of refers to a required constancy of a
RADIATION QUANTITY. In this standard the RADIATION QUANTITY concerned is AIR KERMA
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
−
– 10 – 60601-2-45 IEC:2001(E)
3 General requirements
This clause of the General Standard applies except as follows:
Addition:
Mammographic X-RAY EQUIPMENT shall be designed so as not to deliver in NORMAL USE to any
connected X-RAY TUBE ASSEMBLY a voltage greater than the NOMINAL X-RAY TUBE VOLTAGE for
the X-RAY TUBE ASSEMBLY concerned.
5 Classification
This clause of the General Standard applies except as follows:
5.1 Replacement:
RAY EQUIPMENT CLASS I EQUIPMENT INTERNALLY POWERED
Mammographic X- shall be or
EQUIPMENT.
Replacement:
5.6
Unless otherwise specified, mammographic X-RAY EQUIPMENT or sub-assemblies thereof shall
be classified as suitable for continuous connection to the SUPPLY MAINS in the STAND-BY STATE
and for specified LOADINGS; see also 6.1 m) and 6.8.101.
6 Identification, marking and documents
This clause of the General Standard applies except as follows:
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts
g) Connection to the supply
Addition:
– For mammographic X-RAY EQUIPMENT that is specified to be permanently installed, the
information required in 6.1 g) of the General Standard may be stated in the ACCOMPANYING
DOCUMENTS only.
h) Supply frequency
Addition:
RAY EQUIPMENT
– For mammographic X- that is specified to be permanently installed, the
ACCOMPANYING
information required in 6.1 h) of the General Standard may be stated in the
DOCUMENTS only.
j) Power input
Addition:
For mammographic X-RAY EQUIPMENT that is specified to be permanently installed, the following
information may be stated in the ACCOMPANYING DOCUMENTS only.
60601-2-45 IEC:2001(E) – 11 –
The information on the power input shall be specified in terms of combinations of:
1) the rated MAINS VOLTAGE of the mammographic X-RAY EQUIPMENT in volts; see item g);
2) the number of phases; see item g);
3) the frequency in hertz; see item h);
4) the maximum permissible value for apparent resistance of supply mains in ohms;
5) the characteristics of OVER-CURRENT RELEASES required in the supply mains.
m) Mode of operation
Replacement:
The mode of operation – where appropriate, together with maximum permissible ratings – shall
ACCOMPANYING DOCUMENTS
be stated in the ; see 6.8.101.
n) Fuses
Addition:
For mammographic X-RAY EQUIPMENT that is specified to be permanently installed, this
subclause of the General Standard does not apply; see item j).
p) Output
Replacement:
This subclause of the General Standard does not apply.
Addition:
aa) Marking of compliance
If, for a mammographic X-RAY EQUIPMENT or sub-assembly thereof, compliance with this
standard is to be marked on the outside of the EQUIPMENT, such marking shall be made in
combination with the MODEL OR TYPE REFERENCE as follows:
+)
IEC 60601-2-45
+)
MODEL OR TYPE REFERENCE
6.7 Indicator lights and push-buttons
a) Colours of indicator lights
after the first paragraph:
Addition
For a mammographic X-RAY EQUIPMENT, the colours to be used for indicator lights shall be as
follows:
– the colour green shall be used at the CONTROL PANEL to indicate the state from which one
further action leads to the LOADING STATE, if this state is indicated by a single function
indicator light;
– 12 – 60601-2-45 IEC:2001(E)
– for any indication of the LOADING STATE the colour yellow shall be used to indicate.
NOTE The colours of indicator lights need to be chosen according to the message to be given. Thus, the same
EQUIPMENT
operational state of an can have simultaneous indications in different colours depending upon the place
CONTROL PANEL EXAMINATION ROOM
of indication, for example green at the and red at the entrance to the .
6.8 ACCOMPANYING DOCUMENTS
6.8.1 General
Addition:
The ACCOMPANYING DOCUMENTS shall include a declaration of the dimensions of all available
X-RAY FIELDS.
The ACCOMPANYING DOCUMENTS of any MAMMOGRAPHIC STEREOTACTIC DEVICE designed as an
ACCESSORY RAY EQUIPMENT
for mammographic X- shall contain:
– at least one MODEL OR TYPE REFERENCE to mammographic X-RAY EQUIPMENT with which it is
designed to operate;
– a reference to the relevant standards with which the MAMMOGRAPHIC STEREOTACTIC DEVICE
complies.
6.8.2 INSTRUCTIONS FOR USE
a) General information
Addition:
INSTRUCTIONS FOR USE
– shall contain instructions for the inspection and safe use of all
RAY EQUIPMENT
compression plates used with the mammographic X- .
– INSTRUCTIONS FOR USE of mammographic stereotactic devices shall contain:
instructions for the safe handling and use of needles and CORE BIOPSY GUNS;
•
the designation of the types of needles and CORE BIOPSY GUNS with which they are
•
designed to be used, including a warning against the use of any other types.
Electric output data shall be stated in the INSTRUCTIONS FOR USE in terms of LOADING FACTORS
as described in 6.8.2 a) 1) to 6.8.2 a) 6).
The following combinations and data shall be stated:
1) the NOMINAL X-RAY TUBE VOLTAGE and the highest X-RAY TUBE CURRENT available at that
voltage;
RAY TUBE CURRENT RAY TUBE VOLTAGE
2) the highest X- and the highest X- available at that
current;
3) the corresponding combination of X-RAY TUBE VOLTAGE and X-RAY TUBE CURRENT which
results in the highest electric output power;
4) the NOMINAL ELECTRIC POWER given as the highest constant electric output power in
kilowatts which the X-RAY GENERATOR can deliver, for a LOADING TIME of 0,1 s at an X-RAY
TUBE VOLTAGE of 30 kV or, if these values are not selectable, with an X-RAY TUBE VOLTAGE
nearest to 30 kV and the value of LOADING TIME nearest to but not less than 0,1 s.
The nominal electric power shall be given together with the combination of X-RAY TUBE
VOLTAGE RAY TUBE CURRENT LOADING TIME
and X- and the ;
NOTE The values stated are only for characterising the equipment.
60601-2-45 IEC:2001(E) – 13 –
5) for mammographic X-RAY EQUIPMENT indicating precalculated or measured CURRENT TIME
PRODUCT, the lowest CURRENT TIME PRODUCT or the combinations of LOADING FACTORS
resulting in the lowest CURRENT TIME PRODUCT.
If the value of the lowest CURRENT TIME PRODUCT depends upon the X-RAY TUBE VOLTAGE or
upon certain combinations of values of LOADING FACTORS, the lowest CURRENT TIME PRODUCT
may be given as a table or curve showing the dependence;
6) for mammographic X-RAY EQUIPMENT provided with automatic exposure control controlling
IRRADIATION TIME IRRADIATION TIME
the , the nominal shortest .
If the NOMINAL SHORTEST IRRADIATION TIME depends upon LOADING FACTORS such as X-RAY
TUBE VOLTAGE RAY TUBE CURRENT LOADING FACTORS
and X- , the ranges of these for which the
NOMINAL SHORTEST IRRADIATION TIME is valid shall be stated.
For mammographic X-RAY EQUIPMENT provided with AUTOMATIC EXPOSURE CONTROL controlling
the X-RAY TUBE VOLTAGE or the X-RAY TUBE CURRENT, the range of the X-RAY TUBE VOLTAGE or
the X-RAY TUBE CURRENT during the IRRADIATION shall be stated in the INSTRUCTIONS FOR USE.
Addition:
CONTROLLED AREA
INSTRUCTIONS FOR USE USER
The shall draw the attention of the to the need to restrict access to
the EQUIPMENT in accordance with local regulations for RADIOLOGICAL PROTECTION.
6.8.3 Technical description
Addition:
aa) cooling conditions
The accompanying documents shall state the cooling requirements for safe operation of the
mammographic X-RAY EQUIPMENT, including:
– information concerning the heat dissipation into the surrounding air during NORMAL USE; and
NORMAL USE
– if applicable, information concerning the heat to be removed in by any external
cooling medium, and the details necessary for the provision concerned.
6.8.101 Reference to ACCOMPANYING DOCUMENTS
The following clauses and subclauses of this standard contain additional requirements
concerning the content of ACCOMPANYING DOCUMENTS:
Mode of operation and specified LOADINGS 5.6 and 6.1 m)
..........................................................
Connection to the supply 6.1 g)
..................................................................................................
Number of phases of SUPPLY MAINS 6.1 g) and 6.1 j) 2)
...............................................................
Frequency of SUPPLY MAINS 6.1 h) and 6.1 j) 3)
...........................................................................
Power input 6.1 j)
......................................................................................................................
AINS VOLTAGE
M 6.1 j) 1)
.............................................................................................................
PPARENT RESISTANCE OF SUPPLY MAINS
A 6.1 j) 4) and 10.2.2
........................................................
OVER-CURRENT RELEASE 6.1 j) 5)
................................................................................................
Fuses 6.1 n)
..............................................................................................................................
– 14 – 60601-2-45 IEC:2001(E)
Cooling conditions 6.8.3aa)
........................................................................................................
Electric output data, combinations of LOADING FACTORS 6.8.2 a) and 50.101
...............................
Suitable combinations for compliance test 50.1
.........................................................................
Compliance with this standard 6.8.102
.......................................................................................
Central connection point PROTECTIVE EARTH CONDUCTOR 19.3
.....................................................
Range and interrelation of LOADING FACTORS 29.1.102 e)
............................................................
Test conditions for AUTOMATIC EXPOSURE CONTROL 29.1.102 e)
....................................................
Method to check the AUTOMATIC EXPOSURE CONTROL 29.1.104 d)
.................................................
Combinations with the mammographic X-RAY EQUIPMENT 50.1
....................................................
Suitable test combinations 50.1
.................................................................................................
OADING FACTORS
L and modes of operation 50.101.1 a)
...............................................................
LOADING FACTORS in fixed combinations 50.101.2
.......................................................................
Density correction of AUTOMATIC EXPOSURE CONTROL 50.102.2 dd) 2)
..........................................
6.8.102 Statement of compliance
If for a mammographic X-RAY EQUIPMENT, or for a sub-assembly, compliance with this standard
is to be stated, the statement shall be made in the following form:
++)
mammographic X-RAY EQUIPMENT . IEC 60601-2-45:2001
++)
MODEL OR TYPE REFERENCE
SECTION 2: ENVIRONMENTAL CONDITIONS
The clauses and subclauses of this section of the General Standard apply except as follows:
10 Environmental conditions
This clause of the General Standard applies except as follows:
10.2.2 Power supply
Item a)
Addition:
The internal impedance of a SUPPLY MAINS is to be considered sufficiently low for the operation
of a mammographic X-RAY EQUIPMENT if the value of the APPARENT RESISTANCE OF SUPPLY MAINS
does not exceed the value specified according to 6.1 j) 4).
NOTE The requirements of this standard are based upon the assumption that three-phase systems have a
symmetrical configuration of the MAINS VOLTAGE with respect to earth and include a neutral conductor, and that
single-phase systems are derived from such three-phase systems. A mammographic X-RAY EQUIPMENT is
considered to comply with the requirements of this standard only if its specified NOMINAL ELECTRIC POWER can be
demonstrated at an APPARENT RESISTANCE OF SUPPLY MAINS having a value not less than the APPARENT RESISTANCE
OF SUPPLY MAINS
specified according to 6.1 j) 4).
60601-2-45 IEC:2001(E) – 15 –
For this purpose, the APPARENT RESISTANCE OF SUPPLY MAINS is determined according to the
R
formula:
-
U U
0 1
R =
I1
where
U is the no-load MAINS VOLTAGE;
U is the MAINS VOLTAGE under load;
I is the mains current under load.
The MAINS VOLTAGE shall be measured between
– phase and neutral in a single-phase system;
– phase and phase in a two-phase system;
– each two phases in a three-phase system.
The APPARENT RESISTANCE OF SUPPLY MAINS shall be measured by applying a single resistive
load of a value corresponding approximately to the NOMINAL ELECTRIC POWER specified
according to 6.8.2 a) 4), but not more than 5 kW.
SECTION 3: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
The clauses and subclauses of this section of the General Standard apply except as follows:
15 Limitation of voltage and/or energy
This clause of the General Standard applies except as follows:
Addition:
aa) Detachable high-voltage cable connections to the X-RAY TUBE ASSEMBLY shall be
designed so that the use of TOOLS is required to disconnect them or to remove their
PROTECTIVE COVERS
Compliance is checked by inspection.
bb) Provision shall be made to prevent the appearance of an unacceptably high voltage in
the MAINS PART or in any other low-voltage circuit.
NOTE This may be achieved for example:
– by provision of a winding layer or a conductive screen connected to the protective earth terminal between
high-voltage and low-voltage circuits;
– by provision of a voltage-limiting device across terminals to which external devices are connected and between
which an excessive voltage might arise if the external path becomes discontinuous.
Compliance is checked by inspection of design data and construction.
– 16 – 60601-2-45 IEC:2001(E)
NCLOSURES PROTECTIVE COVERS
16 E and
This clause of the General Standard applies except as follows:
Addition:
NOTE Requirements concerning the resistance and earthing of a flexible conductive screen of high-voltage cables
connected to X-RAY TUBE ASSEMBLIES are given in IEC 60601-2-28.
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
This clause of the General Standard applies except as follows:
19.3 Allowable values
Addition:
RAY EQUIPMENT
For mammographic X- and sub-assemblies thereof the column on Type B and
EARTH LEAKAGE CURRENT NORMAL CONDITION SINGLE FAULT CONDITION
the rows on in and and on
ENCLOSURE LEAKAGE CURRENT in NORMAL CONDITION of table IV, including the notes, of the
General Standard apply.
The allowable values of EARTH LEAKAGE CURRENT are permitted for each sub-assembly of a
mammographic X-RAY EQUIPMENT that is supplied by its own exclusive connection to the SUPPLY
MAINS or to a central connection point, if the latter is fixed and permanently installed.
A fixed and permanently installed central connection point may be provided inside the outer
ENCLOSURE or cover of the mammographic X-RAY EQUIPMENT. If other sub-assemblies such as
RAY SOURCE ASSEMBLY ASSOCIATED EQUIPMENT
an X- or are connected to the central connection
point, the EARTH LEAKAGE CURRENT between such a central connection point and the external
protective system may exceed the allowable values for any one of the single devices
connected.
NOTE The limitation of the EARTH LEAKAGE CURRENTS within the environment of a mammographic X-RAY EQUIPMENT
is intended to ensure that ACCESSIBLE PARTS do not become live and to prevent interference in other electrical
equipment.
The provision of a central connection point is acceptable, as for fixed and PERMANENTLY INSTALLED EQUIPMENT the
interruption of the PROTECTIVE EARTH CONDUCTOR is not considered to be a SINGLE FAULT CONDITION. However, in
such cases, adequate information on the combination of sub-assemblies needs to be provided.
19.3, table IV, note 3)
Addition:
For permanently installed mammographic X-RAY EQUIPMENT, the EARTH LEAKAGE CURRENT under
NORMAL CONDITION SINGLE FAULT CONDITION
and shall not exceed 10 mA (see 19.3 a)).
For permanently installed mammographic X-RAY EQUIPMENT, regardless of waveform and
frequency, the EARTH LEAKAGE CURRENT under NORMAL CONDITION and SINGLE FAULT CONDITION
shall not exceed 20 mA (see 19.3b)).
60601-2-45 IEC:2001(E) – 17 –
19.3, table IV, note 4)
Addition:
For mobile equipment and transportable equipment, the earth leakage current under normal
condition shall not exceed 2,5 mA and under single-fault condition shall not exceed 5 mA. The
enclosure leakage current under single-fault condition shall not exceed 2 mA.
20 Dielectric strength
This clause of the General Standard applies except as follows:
20.3 Values of test voltages
Addition:
The dielectric strength of the electrical insulation of high-voltage circuits shall be sufficient to
withstand the test voltages for the durations given in 20.4 a).
The test voltage shall be 1,2 times the NOMINAL X-RAY TUBE VOLTAGE.
The test shall be carried out with the X-RAY TUBE ASSEMBLY and its interconnecting cables
disconnected, unless the X-RAY TUBE ASSEMBLY is integrated with other parts of the high-
voltage circuit or the MANUFACTURER specifies that the X-RAY TUBE ASSEMBLY is to be connected
during the test.
HIGH VOLTAGE GENERATOR RAY TUBE
If the - can be tested only with the X- connected and if the
X-RAY TUBE does not allow the HIGH-VOLTAGE GENERATOR to be tested with a test voltage of
1,2 times the NOMINAL X-RAY TUBE VOLTAGE, the test voltage shall be lower but not less than
1,1 times that voltage.
20.4 Tests
Item a)
Addition:
The high-voltage circuits are tested by applying a test voltage of 50 % of its final value
according to 20.3 and raising it over a period of 10 s or less to the final value which then is
maintained for the duration of 3 min.
Item d)
Replacement:
During the dielectric strength test, the test voltage in the high-voltage circuit shall be
maintained in the range of 100 % to 105 % of the value required.
Item f)
Addition:
During the dielectric strength test, slight corona discharges in the high-voltage circuit are to be
disregarded if they cease when the test voltage is lowered to 110 % of the voltage to which the
test condition is referred.
– 18 – 60601-2-45 IEC:2001(E)
Item
l)
Addition:
The test voltage for the dielectric strength testing of the stator and stator circuit used for the
operation of the rotating ANODE of the X-RAY TUBE is to be referred to the voltage existing after
reduction of the stator supply voltage to its steady-state operating value.
Additional item aa):
RAY TUBE ASSEMBLY LOADING
1) If the test is to be performed without disconnecting the X- , is to
MANUFACTURER S
be applied in accordance with the ’ recommendations, if any, with particular
RAY TUBE LOAD RAY TUBE
care to avoid exceeding permitted values of X- when the applied X-
VOLTAGE exceeds the NOMINAL X-RAY TUBE VOLTAGE.
2) If the dielectric strength test is performed with an X-RAY TUBE connected and the
high-voltage circuit is not accessible for the measurement of the test voltage applied,
appropriate measures are to be taken to ensure that the values lie within the limits required
in 20.4 d).
SECTION 4: PROTECTION AGAINST MECHANICAL HAZARDS
The clauses and subclauses of this section of the General Standard apply except as follows:
21 Mechanical strength
This clause of the General Standard applies except as follows:
Addition:
21.101 Application of maximum compression force
21.101.1 Motion of ANTI-SCATTER GRID
For mammographic X-RAY EQUIPMENT with a moving ANTI-SCATTER GRID, the application of the
maximum force attainable for the COMPRESSION DEVICE shall not impede the motion of the ANTI-
SCATTER GRID.
Compliance is determined by the following test:
a) Test equipment
The following test equipment is required:
– appropriately sized objects, one for each image receptor format, leading to sufficiently
realistic force distributions when under compression. The objects shall be sand-filled bags
or soft rubber blocks. Their thickness shall be in the range from 20 mm to 50 mm. The
objects shall be 100 mm to 120 mm long and wide for the smallest image receptor format
and 120 mm to 150 mm long and wide for larger formats;
– an aluminium plate of 2 mm thickness and of dimensions sufficient to intercept the whole
RAY BEAM
X- when mounted as described below;
-----
...
IEC 60601-2-45
Edition 2.0 2001-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-45: Particular requirements for the safety of mammographic X-ray
equipment and mammographic stereotactic devices
Appareils électromédicaux –
Partie 2-45: Règles particulières de sécurité pour les appareils de radiographie
mammaire et les appareils mammographiques stéréotaxiques
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by
any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IEC or
IEC's member National Committee in the country of the requester.
If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication,
please contact the address below or your local IEC member National Committee for further information.
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie
et les microfilms, sans l'accord écrit de la CEI ou du Comité national de la CEI du pays du demandeur.
Si vous avez des questions sur le copyright de la CEI ou si vous désirez obtenir des droits supplémentaires sur cette
publication, utilisez les coordonnées ci-après ou contactez le Comité national de la CEI de votre pays de résidence.
IEC Central Office
3, rue de Varembé
CH-1211 Geneva 20
Switzerland
Email: inmail@iec.ch
Web: www.iec.ch
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.
ƒ Catalogue of IEC publications: www.iec.ch/searchpub
The IEC on-line Catalogue enables you to search by a variety of criteria (reference number, text, technical committee,…).
It also gives information on projects, withdrawn and replaced publications.
ƒ IEC Just Published: www.iec.ch/online_news/justpub
Stay up to date on all new IEC publications. Just Published details twice a month all new publications released. Available
on-line and also by email.
ƒ Electropedia: www.electropedia.org
The world's leading online dictionary of electronic and electrical terms containing more than 20 000 terms and definitions
in English and French, with equivalent terms in additional languages. Also known as the International Electrotechnical
Vocabulary online.
ƒ Customer Service Centre: www.iec.ch/webstore/custserv
If you wish to give us your feedback on this publication or need further assistance, please visit the Customer Service
Centre FAQ or contact us:
Email: csc@iec.ch
Tel.: +41 22 919 02 11
Fax: +41 22 919 03 00
A propos de la CEI
La Commission Electrotechnique Internationale (CEI) est la première organisation mondiale qui élabore et publie des
normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.
A propos des publications CEI
Le contenu technique des publications de la CEI est constamment revu. Veuillez vous assurer que vous possédez
l’édition la plus récente, un corrigendum ou amendement peut avoir été publié.
ƒ Catalogue des publications de la CEI: www.iec.ch/searchpub/cur_fut-f.htm
Le Catalogue en-ligne de la CEI vous permet d’effectuer des recherches en utilisant différents critères (numéro de référence,
texte, comité d’études,…). Il donne aussi des informations sur les projets et les publications retirées ou remplacées.
ƒ Just Published CEI: www.iec.ch/online_news/justpub
Restez informé sur les nouvelles publications de la CEI. Just Published détaille deux fois par mois les nouvelles
publications parues. Disponible en-ligne et aussi par email.
ƒ Electropedia: www.electropedia.org
Le premier dictionnaire en ligne au monde de termes électroniques et électriques. Il contient plus de 20 000 termes et
définitions en anglais et en français, ainsi que les termes équivalents dans les langues additionnelles. Egalement appelé
Vocabulaire Electrotechnique International en ligne.
ƒ Service Clients: www.iec.ch/webstore/custserv/custserv_entry-f.htm
Si vous désirez nous donner des commentaires sur cette publication ou si vous avez des questions, visitez le FAQ du
Service clients ou contactez-nous:
Email: csc@iec.ch
Tél.: +41 22 919 02 11
Fax: +41 22 919 03 00
IEC 60601-2-45
Edition 2.0 2001-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-45: Particular requirements for the safety of mammographic X-ray
equipment and mammographic stereotactic devices
Appareils électromédicaux –
Partie 2-45: Règles particulières de sécurité pour les appareils de radiographie
mammaire et les appareils mammographiques stéréotaxiques
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
X
CODE PRIX
ICS 11.040.50 ISBN 2-8318-8519-1
– 2 – 60601-2-45 © CEI:2001
SOMMAIRE
AVANT-PROPOS .6
SECTION 1: GÉNÉRALITÉS
1 Domaine d’application et objet .10
1.1 Domaine d'application.10
1.2 Objet.10
1.3 Normes Particulières .12
2 Terminologie et définitions .14
2.101 Définitions supplémentaires .16
3 Exigences générales.18
5 Classification.18
6 Identification, marquage et documentation .18
6.1 Marquage sur l’extérieur de l’APPAREIL ou des parties d’APPAREIL .18
6.7 Voyants lumineux et boutons poussoirs.22
6.8 Documents d’accompagnement .22
SECTION 2: CONDITIONS D’ENVIRONNEMENT
10 Conditions d'environnement .28
SECTION 3: PROTECTION CONTRE LES RISQUES DE CHOCS ÉLECTRIQUES
15 Limitation des tensions et/ou de l’énergie.30
16 ENVELOPPES et CAPOTS DE PROTECTION .30
19 COURANTS DE FUITE PERMANENTS et COURANTS AUXILIAIRES PATIENT .30
19.3 Valeurs admissibles.30
20 Tension de tenue .32
20.3 Valeurs des tensions d'essai.32
20.4 Essais.34
SECTION 4: PROTECTION CONTRE LES RISQUES MÉCANIQUES
21 Résistance mécanique.36
21.101 Application d’une force de compression maximale .36
22 Parties en mouvement .40
22.101 Mouvement de l’ensemble TUBE RADIOGENE – récepteur d’image .40
22.102 Dispositif de compression .40
22.103 APPAREILS DE MAMMOGRAPHIE STEREOTAXIQUE .44
24 Stabilité en UTILISATION NORMALE.46
SECTION 5: PROTECTION CONTRE LES RISQUES DUS
AUX RAYONNEMENTS NON DÉSIRÉS OU EXCESSIFS
29 RAYONNEMENTS X.48
29.1 RAYONNEMENTS X générés par les EQUIPEMENTS de mammographie A
RAYONNEMENT X .48
60601-2-45 © IEC:2001 – 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
– 4 – 60601-2-45 © CEI:2001
29.207 BARRIERES DE PROTECTION CONTRE LE FAISCEAU .54
29.208 Protection contre les RAYONNEMENTS PARASITES.56
36 Compatibilité électromagnétique .56
SECTION 6: PROTECTION CONTRE LES RISQUES D’IGNITION
DE MÉLANGES ANESTHÉSIQUES INFLAMMABLES
SECTION 7: PROTECTION CONTRE LES TEMPÉRATURES EXCESSIVES
ET LES AUTRES RISQUES
42 Températures excessives.56
SECTION 8: PRECISION DES CARACTÉRISTIQUES DE FONCTIONNEMENT
ET PROTECTION CONTRE LES CARACTÉRISTIQUES DE SORTIE
PRÉSENTANT DES RISQUES
50 Précision des caractéristiques de fonctionnement .58
50.1 Généralités.58
50.101 Indication des caractéristiques de sortie électriques et de RAYONNEMENT .58
50.102 Reproductibilité, linéarité et constance.60
50.103 Précision des PARAMETRES DE CHARGE.64
50.104 Conditions d’essai .66
50.105 Conditions pour la mesure du KERMA DANS L’AIR .68
51 Protection contre les caractéristiques de sortie présentant des risques.70
SECTION 9: FONCTIONNEMENT ANORMAL ET CONDITIONS DE DÉFAUT;
ESSAIS D’ENVIRONNEMENT
SECTION 10: RÈGLES DE CONSTRUCTION
56 Composants et ensembles.70
56.7 Batteries d'accumulateurs.70
57 PARTIES RELIEES AU RESEAU, composants et montage.70
57.10 LIGNES DE FUITE et DISTANCES DANS L'AIR .72
Annexe AA (normative) Terminologie – Index des termes définis .76
Annexe BB (informative) Justification de l'autorisation d'IRRADIATION complète des
mammogrammes .82
Annexe CC (normative) Valeurs des séries R'10 et R'20, ISO 497 .84
Bibliographie .86
Figure 101 – Exemple de DISPOSITIF D’ESSAI pour les APPAREILS DE MAMMOGRAPHIE
.....................................................................................................................74
STEREOTAXIQUE
Tableau 101 – Essais pour la vérification de la reproductibilité et la linéarité.70
60601-2-45 © IEC:2001 – 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
– 6 – 60601-2-45 © CEI:2001
COMMISSION ÉLECTROTECHNIQUE INTERNATIONALE
__________
APPAREILS ÉLECTROMÉDICAUX –
Partie 2-45: Règles particulières de sécurité pour les appareils
de radiographie mammaire et les appareils
mammographiques stéréotaxiques
AVANT-PROPOS
1) La Commission Electrotechnique Internationale (CEI) est une organisation mondiale de normalisation composée
de l'ensemble des comités électrotechniques nationaux (Comités nationaux de la CEI). La CEI a pour objet de
favoriser la coopération internationale pour toutes les questions de normalisation dans les domaines de
l'électricité et de l'électronique. A cet effet, la CEI – entre autres activités – publie des Normes internationales,
des Spécifications techniques, des Rapports techniques, des Spécifications accessibles au public (PAS) et des
Guides (ci-après dénommés "Publication(s) de la CEI"). Leur élaboration est confiée à des comités d'études,
aux travaux desquels tout Comité national intéressé par le sujet traité peut participer. Les organisations
internationales, gouvernementales et non gouvernementales, en liaison avec la CEI, participent également aux
travaux. La CEI collabore étroitement avec l'Organisation Internationale de Normalisation (ISO), selon des
conditions fixées par accord entre les deux organisations.
2) Les décisions ou accords officiels de la CEI concernant les questions techniques représentent, dans la mesure
du possible, un accord international sur les sujets étudiés, étant donné que les Comités nationaux de la CEI
intéressés sont représentés dans chaque comité d’études.
3) Les Publications de la CEI se présentent sous la forme de recommandations internationales et sont agréées
comme telles par les Comités nationaux de la CEI. Tous les efforts raisonnables sont entrepris afin que la CEI
s'assure de l'exactitude du contenu technique de ses publications; la CEI ne peut pas être tenue responsable de
l'éventuelle mauvaise utilisation ou interprétation qui en est faite par un quelconque utilisateur final.
4) Dans le but d'encourager l'uniformité internationale, les Comités nationaux de la CEI s'engagent, dans toute la
mesure possible, à appliquer de façon transparente les Publications de la CEI dans leurs publications
nationales et régionales. Toutes divergences entre toutes Publications de la CEI et toutes publications
nationales ou régionales correspondantes doivent être indiquées en termes clairs dans ces dernières.
5) La CEI n’a prévu aucune procédure de marquage valant indication d’approbation et n'engage pas sa
responsabilité pour les équipements déclarés conformes à une de ses Publications.
6) Tous les utilisateurs doivent s'assurer qu'ils sont en possession de la dernière édition de cette publication.
7) Aucune responsabilité ne doit être imputée à la CEI, à ses administrateurs, employés, auxiliaires ou
mandataires, y compris ses experts particuliers et les membres de ses comités d'études et des Comités
nationaux de la CEI, pour tout préjudice causé en cas de dommages corporels et matériels, ou de tout autre
dommage de quelque nature que ce soit, directe ou indirecte, ou pour supporter les coûts (y compris les frais
de justice) et les dépenses découlant de la publication ou de l'utilisation de cette Publication de la CEI ou de
toute autre Publication de la CEI, ou au crédit qui lui est accordé.
8) L'attention est attirée sur les références normatives citées dans cette publication. L'utilisation de publications
référencées est obligatoire pour une application correcte de la présente publication.
9) L’attention est attirée sur le fait que certains des éléments de la présente Publication de la CEI peuvent faire
l’objet de droits de propriété intellectuelle ou de droits analogues. La CEI ne saurait être tenue pour
responsable de ne pas avoir identifié de tels droits de propriété et de ne pas avoir signalé leur existence.
La Norme internationale CEI 60601-2-45 a été établie par le sous-comité 62B: Appareils
d'imagerie de diagnostic, du comité d’études 62 de la CEI: Equipements électriques dans la
pratique médicale.
Cette seconde édition annule et remplace la première édition publiée en 1998 et constitue une
révision technique.
60601-2-45 © IEC:2001 – 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.
– 8 – 60601-2-45 © CEI:2001
Cette version bilingue, publiée en 2006-02, correspond à la version anglaise.
Le texte anglais de cette norme est issu des documents 62B/427/FDIS et 62B/438/RVD. Le
rapport de vote 62B/438/RVD donne toute information sur le vote ayant abouti à l’approbation
de cette norme.
La version française de cette norme n’a pas été soumise au vote.
Dans la présente norme, les caractères d’imprimerie suivants sont utilisés:
– exigences, dont la conformité peut être vérifiée par un essai, et définitions: caractères
romains;
– explications, conseils, notes, énoncés de portée générale et exceptions: petits caractères romains;
– spécifications d'essai et titres des paragraphes: caractères italiques;
– TERMES DEFINIS DANS L'ARTICLE 2 DE LA NORME GENERALE, DANS LA PRESENTE NORME, DANS LA
CEI 60788 OU DANS D’AUTRES NORMES CEI DONT LES REFERENCES SONT DONNEES A L’ANNEXE AA:
PETITES MAJUSCULES.
NOTE L’attention du lecteur est attirée sur l’existence, dans certains pays, d’une législation concernant la sécurité
RAYONNEMENTS qui peut ne pas s’aligner avec les dispositions de la présente norme.
en matière de
Le comité a décidé que le contenu de cette publication ne sera pas modifié avant la date de
maintenance indiquée sur le site web de la CEI sous «http://webstore.iec.ch» dans les données
relatives à la publication recherchée. A cette date, la publication sera
• reconduite;
• supprimée;
• remplacée par une édition révisée, ou
• amendée.
60601-2-45 © IEC:2001 – 9 –
This bilingual version, published in 2006-02, corresponds to 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.
– 10 – 60601-2-45 © CEI:2001
APPAREILS ÉLECTROMÉDICAUX –
Partie 2-45: Règles particulières de sécurité pour les appareils
de radiographie mammaire et les appareils
mammographiques stéréotaxiques
SECTION 1: GÉNÉRALITÉS
Les articles et paragraphes de la section correspondante de la Norme Générale s’appliquent
avec les exceptions suivantes:
1 Domaine d’application et objet
L'article correspondant de la Norme Générale s’applique avec l'exception suivante:
1.1 Domaine d'application
Addition:
Cette norme particulière contient des exigences relatives à la sécurité des EQUIPEMENTS A
RAYONNEMENT X destinés à la mammographie et des APPAREILS DE MAMMOGRAPHIE STEREO-
TAXIQUE. Les exigences relatives à la sécurité des GROUPES RADIOGENES et de leurs sous-
ensembles font partie intégrante de la présente norme.
1.2 Objet
Remplacement:
La présente norme a pour objet:
1 de donner les exigences de conception et de fabrication appropriées pour la sécurité des
EQUIPEMENTS de mammographie A RAYONNEMENT X et des APPAREILS DE MAMMOGRAPHIE
STEREOTAXIQUE, 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.
NOTE 1 Les exigences concernant la reproductibilité, la linéarité, la constance et la précision sont données en
raison de leur influence sur la qualité et la quantité des RAYONNEMENTS IONISANTS produits et se limitent aux
exigences considérées comme nécessaires pour la sécurité.
NOTE 2 Les niveaux de conformité et les essais prescrits pour déterminer cette conformité montrent que la
sécurité des GENERATEURS RADIOLOGIQUES n’est pas sensible aux petites différences de niveaux de performance.
C’est pourquoi les combinaisons de PARAMETRES DE CHARGE spécifiées pour les essais sont en nombre limité mais
choisies d’après l’expérience acquise pour être appropriées dans la plupart des cas. On considère qu’il est
important de normaliser le choix des combinaisons des PARAMETRES DE CHARGE de manière à pouvoir comparer les
essais réalisés en différents endroits à différentes occasions. Cependant, des combinaisons différentes de celles
spécifiées pourraient avoir la même validité technique.
NOTE 3 La philosophie en matière de sécurité de la présente norme est décrite dans l’introduction de la norme
générale et dans la CEI 60513.
60601-2-45 © IEC:2001 – 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.
– 12 – 60601-2-45 © CEI:2001
NOTE 4 En ce qui concerne la PROTECTION RADIOLOGIQUE, on a estimé au moment de l’établissement de la
présente norme que les CONSTRUCTEURS et les UTILISATEURS acceptaient les principes généraux de la Commission
1)
Internationale de Protection Radiologique (CIPR), tels qu’ils sont définis dans la CIPR 60, 1990, paragraphe 112 ,
à savoir:
"(a) Il convient de n’adopter aucune pratique entraînant des expositions aux rayonnements à moins que les
individus exposés ou la société n’en retirent un bénéfice suffisant pour contrebalancer le préjudice causé en terme
de rayonnement. (Justification d’une pratique.)
(b) Pour toute source particulière dans le cadre d’une pratique, il convient de maintenir à un niveau aussi faible
que possible l’amplitude des doses individuelles, le nombre de personnes exposées et la probabilité de risques
d’expositions lorsqu’il y a incertitude en la matière, en tenant compte des facteurs économiques et sociaux. Il
convient que cette procédure soit encadrée par des restrictions concernant les doses touchant les individus
(contraintes de dose) ou les risques pour les individus en cas d’expositions potentielles (contraintes de risques), de
manière à limiter l’iniquité pouvant résulter des jugements économiques et sociaux en jeu. (Optimisation de la
protection.)
(c) Il convient que l’exposition d’individus résultant de la combinaison de toutes les pratiques applicables soit
soumise à des limites de dose ou à un certain contrôle du risque en cas d’exposition potentielle. Elles sont
destinées à assurer qu’aucun individu n’est exposé à des risques de rayonnements jugés inacceptables à partir de
ces pratiques dans toute circonstance normale. Toutes les sources ne peuvent pas être contrôlées par une action à
la source et il est nécessaire de spécifier les sources à inclure avant de choisir une limite de dose. (dose
individuelle et limites de risques.)"
NOTE 5 La plupart des exigences concernant les EQUIPEMENTS A RAYONNEMENT X et leurs sous-ensembles pour la
protection contre les RAYONNEMENTS IONISANTS sont données dans la Norme Collatérale CEI 60601-1-3.
La présente norme traite, cependant, de certains aspects de PROTECTION RADIOLOGIQUE, essentiellement ceux qui
dépendent de l’alimentation, du contrôle et de l’indication de l’énergie électrique du GENERATEUR RADIOLOGIQUE.
NOTE 6 Il est reconnu que beaucoup de jugements nécessaires pour suivre les principes généraux CIPR doivent
venir de l’UTILISATEUR et non du FABRICANT de l’APPAREIL.
1.3 Normes Particulières
Addition:
La présente Norme Particulière, désignée ci-après sous le terme "la présente norme", modifie
et complète un ensemble de normes CEI, désigné ci-après sous le terme "Norme Générale"
comprenant la CEI 60601-1: Appareils électromédicaux – Partie 1: Règles générales de
sécurité, son Amendement 1 (1991) et son Amendement 2 (1995) et toutes les normes
collatérales.
La numérotation des sections, articles et paragraphes de la présente norme correspond à celle
de la Norme Générale. Les modifications apportées au texte de la Norme Générale sont
précisées en utilisant les termes suivants:
"Remplacement" signifie que l'article ou le paragraphe correspondant de la Norme Générale
est remplacé complètement par le texte de la présente norme.
"Addition" signifie que le texte de la présente norme complète les exigences de la Norme
Générale.
"Amendement" signifie que l'article ou le paragraphe de la Norme Générale est modifié comme
indiqué par le texte de la présente norme.
Les paragraphes ou figures ajoutés à la Norme Générale sont numérotés à partir de 101, les
annexes supplémentaires sont appelées AA, BB, etc., et les points complémentaires aa), bb),
etc.
___________
1)
Publication 60 de la CIRP: Recommandations de la Commission Internationale de Protection Radiologique
(Annales de la CRIP Vol. 21 No 1-3, 1990). Publiée par Pergamon Press
60601-2-45 © IEC:2001 – 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
)
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.
– 14 – 60601-2-45 © CEI:2001
Lorsque la présente norme ne comprend pas une section, un article ou un paragraphe de la
Norme Générale, la section, l'article ou le paragraphe de la Norme Générale s'applique sans
modification.
Lorsqu’il est prévu qu’une partie de la Norme Générale, bien qu’éventuellement pertinente, ne
doit pas être appliquée, une indication doit en être donnée à cet effet dans la présente norme.
Une exigence de la présente norme qui remplace ou modifie des exigences de la Norme
Générale a priorité sur ces exigences de base.
1.3.101 Normes internationales connexes
CEI 60601-2-28:1993, Appareils électromédicaux – Partie 2: Règles particulières de sécurité
pour les ensembles radiogènes à rayonnement X et les gaines équipées pour diagnostic
médical
CEI 60664-1:1992, Coordination de l'isolement des matériels dans les systèmes (réseaux) à
basse tension – Partie 1: Principes, prescriptions et essais
CEI 60788:1984, Radiologie médicale – Terminologie
CEI 61223-3-2:1996, Essais d'évaluation et de routine dans les services d'imagerie médicale –
Partie 3-2: Essais d’acceptation – Performance d’imagerie des APPAREILS de mammographie A
RAYONNEMENT X.
ISO 497:1973, Guide pour le choix des séries de nombres normaux et des séries comportant
des valeurs plus arrondies de nombres normaux
2 Terminologie et définitions
Cet article de la Norme Générale s’applique avec les exceptions suivantes:
Des conditions associées qualifiant l’usage de certains termes sont données en 2.102.
a)
...
Frequently Asked Questions
IEC 60601-2-45:2001 is a standard published by the International Electrotechnical Commission (IEC). Its full title is "Medical electrical equipment - Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices". This standard covers: 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. It is the bilingual version of the english version published in 2001.
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. It is the bilingual version of the english version published in 2001.
IEC 60601-2-45:2001 is classified under the following ICS (International Classification for Standards) categories: 11.040.50 - Radiographic equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
IEC 60601-2-45:2001 has the following relationships with other standards: It is inter standard links to IEC 60601-2-45:1998, IEC 60601-2-45:2011. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase IEC 60601-2-45:2001 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of IEC standards.
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...