EN 60601-2-45:2001

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

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

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

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.

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

General Information

• Status: Withdrawn
• Publication Date: 29-Jul-2001
• Withdrawal Date: 30-Jun-2004
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62B - IEC_SC_62B
• Parallel Committee: IEC/SC 62B - IEC_SC_62B
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 17-Mar-2014
• Completion Date: 17-Mar-2014
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN 60601-2-45:2002 - Medical electrical equipment - Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices (IEC 60601-2-45:2001)

Relations

• Replaced By: EN 60601-2-45:2011 - Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2002
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PDPRJUDIVNRUHQWJHQVNRRSUHPRLQPDPRJUDIVNHVWHUHRWDNWLþQHQDSUDYH,(&

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

EUROPEAN STANDARD EN 60601-2-45
NORME EUROPÉENNE
EUROPÄISCHE NORM July 2001
ICS 11.040.50 Supersedes EN 60601-2-45:1998
English version
Medical electrical equipment
Part 2-45: Particular requirements for the safety of
mammographic X-ray equipment and
mammographic stereotactic devices
(IEC 60601-2-45:2001)
Appareils électromédicaux Medizinische elektrische Geräte
Partie 2-45: Règles particulières Teil 2-45: Besondere Festlegungen
de sécurité pour les appareils de für die Sicherheit von Röntgen-
radiographie mammaire et les appareils Mammographiegeräten und
mammographiques stéréotaxiques mammographischen Stereotaxie-
(CEI 60601-2-45:2001) Einrichtungen
(IEC 60601-2-45:2001)
This European Standard was approved by CENELEC on 2001-07-01. CENELEC members are bound to
comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and
notified to the Central Secretariat has the same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Czech Republic,
Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway,
Portugal, Spain, Sweden, Switzerland and United Kingdom.
CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
Central Secretariat: rue de Stassart 35, B - 1050 Brussels
© 2001 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-45:2001 E
Foreword
The text of document 62B/427/FDIS, future edition 2 of IEC 60601-2-45, prepared by SC 62B,
Diagnostic imaging equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted
to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-45 on 2001-07-01.
This European Standard supersedes EN 60601-2-45:1998.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2002-04-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2004-07-01
Annexes designated "normative" are part of the body of the standard.
Annexes designated "informative" are given for information only.
In this standard, annexes AA and CC are normative and annex BB is informative.
In this standard, the following print types are used:
– requirements, compliance with which can be tested, and definitions: roman type;
– explanations, advice, notes, general statements and exceptions: smaller roman type;
– test specifications and headings of subclauses: italic type;
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD, IN THIS STANDARD, IN IEC 60788 OR IN OTHER
IEC STANDARDS REFERENCED IN ANNEX AA: SMALL CAPITALS.
NOTE  Attention is drawn to the existence of legislation in some countries concerning RADIATION safety which may not align with
the provisions of this standard.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-45:2001 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 60417-2 NOTE  Harmonized as EN 60417-2:1998 (not modified).
IEC 60601-2-32 NOTE  Harmonized as EN 60601-2-32:1994(not modified).
IEC 60613 NOTE  Harmonized as EN 60613:1990 (not modified).
__________
NORME CEI
INTERNATIONALE
IEC
60601-2-45
INTERNATIONAL
Deuxième édition
STANDARD
Second edition
2001-05
Appareils électromédicaux –
Partie 2-45:
Règles particulières de sécurité pour
les appareils de radiographie mammaire et les
appareils mammographiques stéréotaxiques

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

 IEC 2006 Droits de reproduction réservés  Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in any
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électronique ou mécanique, y compris la photocopie et les photocopying and microfilm, without permission in writing from
microfilms, sans l'accord écrit de l'éditeur. the publisher.
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Telephone: [phone] Telefax: [phone] E-mail: [e-mail] Web: www.iec.ch
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Pour prix, voir catalogue en vigueur
For price, see current catalogue

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

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

SECTION 2: ENVIRONMENTAL CONDITIONS
10 Environmental conditions .29

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

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

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

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

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

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

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

SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
SECTION 10: CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly.71
56.7 Batteries.71
57 MAINS PARTS, components and layout.71
57.10 CREEPAGE DISTANCES and AIR CLEARANCES .73

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

Bibliography .87

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

Table 101 – Tests for verifying reproducibility and linearity .71

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

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

FOREWORD
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agreement between the two orga
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