EN 60601-1-3:2008
(Main)Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
This collateral standard applies to X-ray equipment and to subassemblies of such equipment, where radiological images of a human patient are used for diagnosis, planning or guidance of medical procedures. The object of this collateral standard is to establish general requirements for protection against X-radiation in X-ray equipment, in order that the irradiation of the human patient, the operator, staff and members of the public can be kept as low as reasonably achievable, without jeopardizing the benefit of the radiological procedure. Particular standards may specify their appropriate values and/or measures for general requirements specified in this collateral standard. The implementation of the general requirements or the reference to the particular standard instead, shall be justified in the risk management process. This collateral standard considers radiation protection aspects related to X-radiation only. Requirements for the control of the electrical energy used to generate X-radiation, which is also an important aspect of radiation protection, are included in IEC 60601-1 and in particular standards for the safety and essential performance of the equipment concerned. This document cancels and replaces the first edition of IEC 60601-1-3, published in 1994 (which replaced IEC 407 issued in 1973). It constitutes a technical revision. This edition has been restructured and aligned to IEC 60601-1(2005) and focussed on general requirements for RADIATION PROTECTION that apply to all diagnostic X-RAY EQUIPMENT. Requirements particular to specific equipment have been removed and will be covered in particular standards. For a description of the changes, see the mapping in Annex C.
Medizinische elektrische Geräte - Teil 1-3: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Strahlenschutz von diagnostischen Röntgengeräten
Appareils électromédicaux - Partie 1-3: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Radioprotection dans les appareils à rayonnement X de diagnostic
La présente norme collatérale s'applique aux appareils à rayonnement X et à leurs sous-ensembles, dont les images radiologiques d'un patient humain sont utilisées à des fins de diagnostic, de planification ou de guide pour les procédures médicales. L'objet de la présente norme collatérale est d'établir des exigences générales pour la protection contre les rayonnements X dans les appareils à rayonnement X, afin que l'irradiation des patients humains, de l'opérateur, des membres de l'équipe médicale et des autres personnes présentes puisse être maintenue à un niveau aussi bas que raisonnablement possible, sans compromettre le bénéfice de la procédure radiologique. Des normes particulières peuvent spécifier des valeurs et/ou mesures qui leur sont appropriées par rapport aux exigences générales spécifiées dans la présente norme collatérale. La mise en uvre des exigences générales ou, à la place, la référence à la norme particulière doit être justifiée dans le processus de gestion des risques. La présente norme collatérale traite des aspects de radioprotection liés aux rayonnements X uniquement. Les exigences pour la commande de l'énergie électrique utilisée pour produire le rayonnement X, qui est aussi un aspect important de la radioprotection, figurent dans la CEI 60601-1 et dans les normes particulières pour la sécurité et les performances essentielles des appareils concernés. Ce document annule et remplace la première édition de la CEI 60601-1-3, publiée en 1994 (qui a remplacé la CEI 407 publiée en 1973). Elle constitue une révision technique. La présente édition a été restructurée et alignée avec la CEI 60601-1 (2005) et traite des exigences générales pour la radioprotection qui s'appliquent à tous les appareils à rayonnement X de diagnostic. Les exigences particulières pour des appareils spécifiques ont été enlevées et seront couvertes dans des normes particulières. Pour une description des modifications, voir la correspondance présentée à l'Annexe C.
Medicinska električna oprema - 1-3. del: Splošne zahteve za osnovno varnost in bistvene lastnosti - Spremljevalni standard: Varstvo pred sevanjem pri rentgenski diagnostični opremi (IEC 60601-1-3:2008)
Ta mednarodni standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI MEDICINSKE ELEKTRIČNE OPREME in MEDICINSKIH ELEKTRIČNIH SISTEMOV (v nadaljevanju tudi: ELEKTROMEDICINSKA OPREMA in ELEKTROMEDICINSKI SISTEM). Ta spremljevalni standard se uporablja za RENTGENSKO OPREMO in podsestave tovrstne opreme,
kadar se RADIOLOŠKE SLIKE človeških PACIENTOV uporabljajo za diagnosticiranje, načrtovanje ali usmerjanje medicinskih postopkov.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2008
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SIST EN 60601-1-3:1998
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ELVWYHQHODVWQRVWL6SUHPOMHYDOQLVWDQGDUG 9DUVWYRSUHGVHYDQMHPSULUHQWJHQVNL
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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)
Medizinische elektrische Geräte - Teil 1-3: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Strahlenschutz
von diagnostischen Röntgengeräten (IEC 60601-1-3:2008)
Appareils électromédicaux - Partie 1-3: Exigences générales pour la sécurité de base et
les performances essentielles - Norme collatérale: Radioprotection dans les appareils a
rayonnement X de diagnostic (CEI 60601-1-3:2008)
Ta slovenski standard je istoveten z: EN 60601-1-3:2008
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 60601-1-3
NORME EUROPÉENNE
April 2008
EUROPÄISCHE NORM
ICS 11.040.50; 13.280 Supersedes EN 60601-1-3:1994
English version
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)
Appareils électromédicaux - Medizinische elektrische Geräte -
Partie 1-3: Exigences générales Teil 1-3: Allgemeine Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles - der wesentlichen Leistungsmerkmale -
Norme collatérale: Radioprotection Ergänzungsnorm: Strahlenschutz
dans les appareils à rayonnement X von diagnostischen Röntgengeräten
de diagnostic (IEC 60601-1-3:2008)
(CEI 60601-1-3:2008)
This European Standard was approved by CENELEC on 2008-03-01. 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, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
Central Secretariat: rue de Stassart 35, B - 1050 Brussels
© 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-1-3:2008 E
Foreword
The text of document 62B/673/FDIS, future edition 2 of IEC 60601-1-3, 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 60601-1-3 on 2008-03-01.
The following date was fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
(dop) 2008-12-01
national standard or by endorsement
This European Standard supersedes EN 60601-1-3:1994. However, EN 60601-1-3:1994 remains valid
until all the Parts 2 that are used in conjunction with it have been withdrawn. No date of withdrawal of
conflicting national standards (dow) has therefore been fixed. However, when Part 1-3 is used for
appliances not covered by a Part 2, EN 60601-1-3:1994 is not to be used after 2009-09-12.
This EN 60601-1-3 has been restructured and aligned to EN 60601-1:2006 and focussed on general
requirements for RADIATION PROTECTION that apply to all diagnostic X-RAY EQUIPMENT. Requirements
particular to specific equipment have been removed and will be covered in particular standards. For a
description of the changes, see the mapping in Annex C.
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive 93/42/EEC. See Annex ZZ.
This European Standard constitutes a collateral standard to EN 60601-1:2006, hereafter referred to as
the general standard.
In the 60601 series of publications, collateral standards specify general requirements for safety applicable
to:
– a subgroup of MEDICAL ELECTRICAL EQUIPMENT (e.g. RADIOLOGICAL equipment); or
– a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT, not fully addressed in the general
standard (e.g. alarm systems).
In this collateral standard, the following print types are used:
− requirements and definitions: in roman type;
− test specifications: in italic type;
− informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of
tables is also in a smaller type;
− TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS COLLATERAL STANDARD OR AS NOTED: IN
SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the thirteen numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 7 includes Subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of
Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the clause
number. References to subclauses within this standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination
of the conditions is true.
- 3 - EN 60601-1-3:2008
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives,
Part 2. For the purposes of this standard, the auxiliary verb
− “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
− “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;
− “may” is used to describe a permissible way to achieve compliance with a requirement or test.
Clauses, subclauses and definitions for which a rationale is provided in informative Annex A are marked
with an asterisk (*).
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-1-3:2008 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
IEC 60601-2-7 NOTE Harmonized as EN 60601-2-7:1998 (not modified).
IEC 60601-2-28 NOTE Harmonized as EN 60601-2-28:1993 (not modified).
IEC 60601-2-29 NOTE Harmonized as EN 60601-2-29:1999 (not modified).
IEC 60601-2-32 NOTE Harmonized as EN 60601-2-32:1994 (not modified).
IEC 60601-2-43 NOTE Harmonized as EN 60601-2-43:2000 (not modified).
IEC 60601-2-44 NOTE Harmonized as EN 60601-2-44:2001 (not modified).
IEC 60601-2-45 NOTE Harmonized as EN 60601-2-45:2001 (not modified).
IEC 60580 NOTE Harmonized as EN 60580:2000 (not modified).
IEC 60627 NOTE Harmonized as EN 60627:2001 (not modified).
IEC 61262 NOTE Harmonized in EN 61262 series (not modified).
IEC 62220 NOTE Harmonized in EN 62220 series (not modified).
IEC 62220-1 NOTE Harmonized as EN 62220-1:2003 (not modified).
__________
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Publication Year Title EN/HD Year
1) 2)
IEC 60336 - Medical electrical equipment - X-ray tube EN 60336 2005
assemblies for medical diagnosis -
Characteristics of focal spots
IEC 60522 1999 Determination of the permanent filtration of EN 60522 1999
X-ray tube assemblies
IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic safety
and essential performance
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
1)
ISO 497 - Guide to the choice of series of preferred - -
numbers and series containing more rounded
values of preferred numbers
1)
Undated reference.
2)
Valid edition at date of issue.
- 5 - EN 60601-1-3:2008
Annex ZZ
(informative)
Coverage of Essential Requirements of EC Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers all
relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.
IEC 60601-1-3
Edition 2.0 2008-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 1-3: General requirements for basic safety and essential performance –
Collateral Standard: Radiation protection in diagnostic X-ray equipment
Appareils électromédicaux –
Partie 1-3: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Radioprotection dans les appareils à
rayonnement X de diagnostic
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
X
CODE PRIX
ICS 11.040.50; 13.280 ISBN 2-8318-9541-3
– 2 – 60601-1-3 © IEC:2008
CONTENTS
FOREWORD.5
INTRODUCTION.8
1 Scope, object and related standards.9
1.1 Scope.9
1.2 Object .9
1.3 Related standards .9
1.3.1 IEC 60601-1 .9
1.3.2 Particular standards .9
2 Normative references .10
3 Terms and definitions .10
4 General requirements .20
4.1 Statement of compliance .20
4.2 Composition of reference materials .20
5 ME EQUIPMENT identification, marking and documents .20
5.1 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts .20
5.1.1 General .20
5.1.2 Marking requirements in subclauses.20
5.2 ACCOMPANYING DOCUMENTS.20
5.2.1 References in subclauses.21
5.2.2 Dosimetric calibration .21
5.2.3 General requirements for the reference of subassemblies and
ACCESSORIES.21
5.2.4 Instructions for use.22
6 RADIATION management.23
6.1 General .23
6.2 Initiation and termination of the IRRADIATION .24
6.2.1 Normal initiation and termination of the IRRADIATION.24
6.2.2 Safety measures against failure of normal termination of the
IRRADIATION.24
6.3 RADIATION dose and RADIATION QUALITY.24
6.3.1 Adjustment of RADIATION dose and RADIATION QUALITY .24
6.3.2 R
...
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