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

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

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Published
Publication Date
01-Aug-2022
Current Stage
PPUB - Publication issued
Completion Date
02-Aug-2022
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IEC 60601-2-45:2011/AMD2:2022 - Amendment 2 - Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
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IEC 60601-2-45
Edition 3.0 2022-08
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 2
AMENDEMENT 2
Medical electrical equipment –
Part 2-45: Particular requirements for the basic safety and essential
performance of mammographic X-ray equipment and mammographic
stereotactic devices
Appareils électromédicaux –
Partie 2-45: Exigences particulières pour la sécurité de base et les
performances essentielles des appareils de mammographie à rayonnement X et
des appareils mammographiques stéréotaxiques
IEC 60601-2-45:2011-02/AMD2:2022-08(en-fr)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
IEC 60601-2-45
Edition 3.0 2022-08
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 2
AM ENDEMENT 2
Medical electrical equipment –
Part 2-45: Particular requirements for the basic safety and essential
performance of mammographic X-ray equipment and mammographic
stereotactic devices
Appareils électromédicaux –
Partie 2-45: Exigences particulières pour la sécurité de base et les
performances essentielles des appareils de mammographie à rayonnement X et
des appareils mammographiques stéréotaxiques
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-4876-8

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 3 ----------------------
– 2 – IEC 60601-2-45:2011/AMD2:2022
© IEC 2022
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-45: Particular requirements for the basic safety and
essential performance of mammographic X-ray equipment
and mammographic stereotactic devices
AMENDMENT 2
FOREWORD

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

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

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

in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,

Publicly Available Specifications (PAS) and Guides (hereafter referred to as "IEC Publication(s)"). Their

preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with

may participate in this preparatory work. International, governmental and non-governmental organizations liaising

with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for

Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.

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

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

interested IEC National Committees.

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

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

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

misinterpretation by any end user.

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

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

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

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

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

services carried out by independent certification bodies.

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

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

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

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

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

Publications.

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

indispensable for the correct application of this publication.

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

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

Amendment 2 to IEC 60601-2-45:2011 has been prepared by subcommittee 62B: Diagnostic

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

The text of this Amendment is based on the following documents:
Draft Report on voting
62B/1271/CDV 62B/1282/RVC

Full information on the voting for its approval can be found in the report on voting indicated in

the above table.
The language used for the development of this Amendment is English.
---------------------- Page: 4 ----------------------
IEC 60601-2-45:2011/AMD2:2022 – 3 –
© IEC 2022

This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in

accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available

at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are

described in greater detail at www.iec.ch/standardsdev/publications/.

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

stability date indicated on the IEC website under webstore.iec.ch in the data related to the

specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

NOTE The attention of National Committees is drawn to the fact that equipment MANUFACTURERS and testing

organizations may need a transitional period following publication of a new, amended or revised IEC publication in

which to make products in accordance with the new requirements and to equip themselves for conducting new or

revised tests. It is the recommendation of the committee that the content of this publication be adopted for

implementation nationally not earlier than 3 years from the date of publication.
___________
INTRODUCTION to Amendment 2

This second amendment to the third edition of this particular standard has been prepared to

provide a complete set of safety requirements for MAMMOGRAPHIC X-RAY EQUIPMENT, based on

the second amendment (2020) to IEC 60601-1:2005 and associated collateral standards.

Moreover, in Annex AA the description of the term for ESSENTIAL PERFORMANCE is modified to

better reflect the clarification published as interpretation sheet 1 of IEC 60601-1:2005/

AMD1:2012. This particular standard addresses the system level of MAMMOGRAPHIC X-RAY

EQUIPMENT including the equipment for MAMMOGRAPHIC TOMOSYNTHESIS.
---------------------- Page: 5 ----------------------
– 4 – IEC 60601-2-45:2011/AMD2:2022
© IEC 2022
FOREWORD

Replace, in the second paragraph, “IEC 60601-1-3 (2008)”, modified by Amendment 1, with

“IEC 60601-1-3 (2008), Amendment 1 of IEC 60601-1-3 (2013) and Amendment 2 of IEC 60601-

1-3 (2021)”.
201.1 Scope, object and related standards

Replace, in footnote 1), “IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012”, modified by

Amendment 1, with “IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
1:2005/AMD2:2020”.
201.1.3 Collateral standards
Replace the first sentence of the second paragraph with:

IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-3:2008, IEC 60601-1-

3:2008/AMD1:2013 and IEC 60601-1-3:2008/AMD2:2021 apply as modified in Clauses 202 and

203, respectively.

Replace, at the end of the second sentence of the second paragraph, modified by Amendment

1, the existing footnote with:
201.2 Normative references

Replace the existing reference to IEC 60601-1-2:2014, modified by Amendment 1, with:

IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic

safety and essential performance – Collateral standard: Electromagnetic disturbances –

Requirements and tests
IEC 60601-1-2:2014/AMD1:2020

Replace the existing reference to IEC 60601-1-3:2008, modified by Amendment 1, with:

IEC 60601-1-3:2008, Medical electrical equipment – Part 1-3: General requirements for basic

safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-

ray equipment
IEC 60601-1-3:2008/AMD1:2013
IEC 60601-1-3:2008/AMD2:2021
___________

IEC 60601-1-8, Medical electrical equipment – Part 1-8: General requirements for basic safety and essential

performance – Collateral standard: General requirements, tests and guidance for alarm systems in medical

electrical equipment and medical electrical systems. IEC 60601-1-9, Medical electrical equipment – Part 1-9:

General requirements for basic safety and essential performance – Collateral Standard: Requirements for

environmentally conscious design. IEC 60601-1-10, Medical electrical equipment – Part 1-10: General

requirements for basic safety and essential performance – Collateral Standard: Requirements for the

development of physiologic closed-loop controllers. IEC 60601-1-11, Medical electrical equipment – Part 1-11:

General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical

electrical equipment and medical electrical systems used in the home healthcare environment. IEC 60601-1-12,

Medical electrical equipment – Part 1-12: General requirements for basic safety and essential performance –

Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for

use in the emergency medical services environment.
---------------------- Page: 6 ----------------------
IEC 60601-2-45:2011/AMD2:2022 – 5 –
© IEC 2022
Add, under "Addition:", the following reference:

IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety

and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
Replace the existing reference “IEC 60788:2004” with “IEC TR 60788:2004”.
201.3 Terms and definitions

Replace the first paragraph of this subclause, modified by Amendment 1, with the following:

For the purposes of this document, the terms and definitions given in IEC 60601-1,

IEC 60601‑1‑3 and IEC TR 60788 apply, except as follows:
201.4.3.101 *Additional ESSENTIAL PERFORMANCE requirements
Replace the title of this subclause with the following new title:
201.4.3.101 *Additional potential ESSENTIAL PERFORMANCE requirements
Replace the first paragraph of this subclause with the following:

Additional potential ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in

Table 201.101.
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements
Replace the existing title of the table with the following new title:
Table 201.101 – Distributed potential ESSENTIAL PERFORMANCE requirements
Add, after the existing Subclause 201.7.8.102, the following new subclause:
201.7.8.1 Colours of indicator lights
Addition:

Yellow and green colours of lights which are listed in Table 2 of the general standard should

only be used if they are clearly distinguishable from the indication the X-ray related states as

required in Subclause 203.6.4.2.

If applicable, conflicts which may arise from using same or similar colours for indication of X-

RAY related states and other functions of the ME EQUIPMENT shall be evaluated by using the

USABILITY ENGINEERING process.

Colours of indicator lights and alarm indicator lights for ME EQUIPMENT which are designated as

HIGH PRIORITY, MEDIUM PRIORITY, and LOW PRIORITY ALARM CONDITION listed in Table 2 of the

general standard do not apply to this particular standard.

NOTE Even though 7.8 of the general standard mentions the collateral standard IEC 60601-1-8 which application

is excluded in 201.1.3 of this particular standard, the selected specified references therein are considered informative

and help to understand the requirements of 7.8.
Compliance is checked by inspection of the USABILITY ENGINEERING FILE.
---------------------- Page: 7 ----------------------
– 6 – IEC 60601-2-45:2011/AMD2:2022
© IEC 2022
201.7.9.2.17 *ME EQUIPMENT emitting radiation

Replace the first paragraph of this subclause, added by Amendment 1, with the following:

This subclause of IEC 60601-1 does not apply.

201.10.1.2 ME EQUIPMENT intended to produce diagnostic or therapeutic X-radiation

Replace, in the first paragraph of this subclause, modified by Amendment 1, the reference to

“IEC 60601-1-3:2008 and IEC 60601-1-3:2008/AMD1:2013” with “IEC 60601-1-3”.
202 Electromagnetic compatibility – Requirements and tests

Replace, in the first line, modified by Amendment 1, “IEC 60601-1-2:2007” with “IEC 60601-1-

2:2014 and IEC 60601-1-2:2014/AMD1:2020”.
203 Radiation protection in diagnostic X-ray equipment

Replace, in the first line, modified by Amendment 1, “IEC 60601-1-3:2008 and IEC 60601-1-

3:2008/AMD1:2013” with “IEC 60601-1-3:2008, IEC 60601-1-3:2008/AMD1:2013 and
IEC 60601-1-3:2008/AMD2:2021”.
203.4.1 Statement of compliance

Replace the existing reference to “IEC 60601-2-45:2015”, modified by Amendment 1, with

“IEC 60601-2-45:2011, IEC 60601-2-45:2011/AMD1:2015 and IEC 60601-2-
45:2011/AMD2:2022”.
203.4.101.2 *LOADING TIME

Delete, in Note 1 the reference to “and IEC 60601-1-3:2008/AMD1:2013”, added by Amendment

203.6.3.1.1 General requirements for the adjustment of RADIATION dose and RADIATION

QUALITY

Replace in the second paragraph, modified by Amendment 1, the reference to “IEC 60601-1-

3:2008 and IEC 60601-1-3:2008/AMD1:2013” with “IEC 60601-1-3:2008,
IEC 60601-1-3:2008/AMD1:2013 and IEC 60601-1-3:2008/AMD2:2021”.
203.6.7.104.1 Minimum AIR KERMA RATE
Replace in the third paragraph, modified by Amendment 1, “IEC 60601-1-3:2008 and

IEC 60601-1-3:2008/AMD1:2013” with “IEC 60601-1-3:2008, IEC 60601-1-3:2008/AMD1:2013

and IEC 60601-1-3:2008/AMD2:2021”.
203.7.3 Indication of FILTER properties

Delete, in the existing text, the reference to “and IEC 60601-1-3:2008/AMD1:2013”, added by

Amendment 1.
---------------------- Page: 8 ----------------------
IEC 60601-2-45:2011/AMD2:2022 – 7 –
© IEC 2022
Annex AA – Particular guidance and rationale
AA.1 Rationale for particular clauses and subclauses
Subclause 201.4.3.101 – Additional ESSENTIAL PERFORMANCE requirements
Replace the existing text and title with the following:
Subclause 201.4.3.101 – Additional potential ESSENTIAL PERFORMANCE requirements
IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 state that the term ESSENTIAL

PERFORMANCE is directly related to the performance of a clinical function (definition 3.27 in

IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012). Table 201.101 of this particular

standard provides a list of requirements that can be correlated with the performance of a clinical

function and that can therefore be ESSENTIAL PERFORMANCE. The decision on whether any of

these requirements constitutes ESSENTIAL PERFORMANCE is subject to a RISK EVALUATION that

considers the INTENDED USE of the ME EQUIPMENT.

The identification of potential ESSENTIAL PERFORMANCE requirements is justified because the

RISK associated with ionizing X-RADIATION used to generate mammographic images is

overweighed by the benefits expected from the procedure (e.g., breast screening). Evidence is

provided by several state-of-the-art clinical studies [12][13][14][15][16] based on diagnostic

data generated by MAMMOGRAPHIC X-RAY EQUIPMENT in the field.

The intent of the requirements in this particular standard is to support manufacturers in

providing state-of-the-art X-ray equipment that is safe and effective under normal conditions

and SINGLE FAULT CONDITIONS as described below. The effectiveness is ensured by meeting the

ESSENTIAL PERFORMANCE requirements.

Requirements under single fault conditions are either stipulated in clauses of the general

standard and this particular standard or are determined by the risk evaluation. There can be

some cases in which simply detection of a single faults during regular checks within a

maintenance or a quality control procedure are considered sufficient. In some other cases, a

risk which occurs under single fault conditions is considered acceptable due to its low

probability or low severity. However, single fault conditions that result in an unacceptable risk

due to the probability of harm or the severity of harm require additional control measures. These

could include frequent functional self-monitoring, and installation of redundant parts, or

appropriate protective devices.

Refer to IEC 60601-1:2005/AMD1:2012/ISH1:2021 [17] for further information on "ESSENTIAL

PERFORMANCE in SINGLE FAULT CONDITION".
---------------------- Page: 9 ----------------------
– 8 – IEC 60601-2-45:2011/AMD2:2022
© IEC 2022
Bibliography

Add, after the existing list, modified by Amendment 1, the following new bibliographic

references:

[12] Hendrick RE, "Radiation Doses and Risks in Breast Screening," J Breast Imag, vol. 2,

pp 188-200, 2020.

[13] Martha B. Pitman, MD, "Current Controversies in Screening Mammography," Cancer

Cytopathology, pp. 559-560, 2014.

[14] R.M.K. M.Ali, A. England, M.F. McEntee, C.E. Mercer, A. Tootell, P. Hogg, "Effective

lifetime radiation risk for a number of national mammography screening programmes,"

Radiography, pp. 240-246, 2018.

[15] R. Edward Hendrick and Mark A. Helvie, "Mammography Screening: A New Estimate of

Number Needed to Screen to Prevent One Breast Cancer Death," American Journal of
Roentgenology, pp. 723-728., 2012.

[16] Raed M.K. M.Ali, Andrew England, Claire Mercer, Andrew Tootell, Lucy Walton, Wouter

Schaake, Peter Hogg, "Mathematical modelling of radiation-induced cancer risk from

breast screening by mammography," European Journal of Radiology, pp. 98-103, 2017.

[17] IEC 60601-1:2005/AMD1:2012/ISH1:2021, Interpretation Sheet 1 – Amendment 1 –

Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance
---------------------- Page: 10 ----------------------
IEC 60601-2-45:2011/AMD2:2022 – 9 –
© IEC 2022
Index of defined terms used in this particular standard

Replace the existing line for HAZARD, modified by Amendment 1, with the following:

HAZARD ............................................................................. IEC 60601-1:2005/AMD2:2020, 3.39

Replace the existing line for INTENDED USE, modified by Amendment 1, with the following:

INTENDED USE .............................................. IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012

........................................................................... and IEC 60601-1:2005/AMD2:2020, 3.44

Replace the existing line for MANUFACTURER, modified by Amendment 1, with the following:

MANUFACTURER ............................. IEC 60601-1:2005 and IEC 60601-1:2005/AMD2:2020, 3.55

Replace the existing line for PROCESS, modified by Amendment 1, with the following:

PROCESS ....................................... IEC 60601-1:2005 and IEC 60601-1:2005/AMD2:2020, 3.89

Replace the existing lines for RISK, RISK MANAGEMENT and RISK MANAGEMENT FILE, modified by

Amendment 1, with the following:

RISK ............................................................ IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012

......................................................................... and IEC 60601-1:2005/AMD2:2020, 3.102

RISK MANAGEMENT ....................................... IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012

......................................................................... and IEC 60601-1:2005/AMD2:2020, 3.107

RISK MANAGEMENT FILE ................................. IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012

......................................................................... and IEC 60601-1:2005/AMD2:2020, 3.108

Add the following new lines:

PROCEDURE ................................... IEC 60601-1:2005 and IEC 60601-1:2005/AMD2:2020, 3.88

USABILITY ENGINEERING ................ IEC 60601-1:2005 and IEC 60601-1:2005/AMD2:2020, 3.137

___________
---------------------- Page: 11 ----------------------
– 10 – IEC 60601-2-45:2011/AMD2:2022
© IEC 2022
COMMISSION ÉLECTROTECHNIQUE INTERNATIONALE
____________
APPAREILS ÉLECTROMÉDICAUX –
Partie 2-45: Exigences particulières pour la sécurité de base et
les performances essentielles des appareils de mammographie à
rayonnement X et des appareils mammographiques stéréotaxiques
AMENDEMENT 2
AVANT-PROPOS

1) La Commission Electrotechnique Internationale (IEC) est une organisation mondiale de normalisation composée

de l'ensemble des comités électrotechniques nationaux (Comités nationaux de l’IEC). L’IEC 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, l’IEC – 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 l’IEC"). 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 l’IEC, participent également aux

travaux. L’IEC 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 l’IEC concernant les questions techniques représentent, dans la mesure du

possible, un accord international sur les sujets étudiés, étant donné que les Comités nationaux de l’IEC intéressés

sont représentés dans chaque comité d’études.

3) Les Publications de l’IEC se présentent sous la forme de recommandations internationales et sont agréées

comme telles par les Comités nationaux de l’IEC. Tous les efforts raisonnables sont entrepris afin que l’IEC

s'assure de l'exactitude du contenu technique de ses publications; l’IEC 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 l’IEC s'engagent, dans toute la

mesure possible, à appliquer de façon transparente les Publications de l’IEC dans leurs publications nationales

et régionales. Toutes divergences entre toutes Publications de l’IEC et toutes publications nationales ou

régionales correspondantes doivent être indiquées en termes clairs dans ces dernières.

5) L’IEC elle-même ne fournit aucune attestation de conformité. Des organismes de certification indépendants

fournissent des services d'évaluation de conformité et, dans certains secteurs, accèdent aux marques de

conformité de l’IEC. L’IEC n'est responsable d'aucun des services effectués par les organismes de certification

indépendants.

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 l’IEC, 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 l’IEC,

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 l’IEC ou de toute autre Publication de l’IEC,

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 du présent document de l'IEC peuvent faire l’objet de

droits de brevet. L’IEC ne saurait être tenue po
...

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