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SLOVENSKI STANDARD
01-julij-2018
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Medical electrical equipment - Part 2-43: Particular requirements for basic safety and
essential performance of X-ray equipment for interventional procedures (IEC 60601-2-
43:2010/A1:2017)
Medizinische elektrische Geräte - Teil 2-43: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Röntgeneinrichtungen für
interventionelle Verfahren (IEC 60601-2-43:2010/A1:2017)
Appareils électromédicaux - Partie 2-43: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils à rayonnement X lors d'interventions (IEC
60601-2-43:2010/A1:2017)
Ta slovenski standard je istoveten z: EN 60601-2-43:2010/A1:2018
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 60601-2-43:2010/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2018
ICS 11.040.50; 37.040.25
English Version
Medical electrical equipment - Part 2-43: Particular requirements
for the basic safety and essential performance of X-ray
equipment for interventional procedures
(IEC 60601-2-43:2010/A1:2017)
Appareils électromédicaux - Partie 2-43: Exigences Medizinische elektrische Geräte - Teil 2-43: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit und wesentlichen
essentielles des appareils à rayonnement X lors Leistungsmerkmale von Röntgeneinrichtungen für
d'interventions interventionelle Verfahren
(IEC 60601-2-43:2010/A1:2017) (IEC 60601-2-43:2010/A1:2017)
This amendment A1 modifies the European Standard EN 60601-2-43:2010; it was approved by CENELEC on 2017-07-05. CENELEC
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment 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 CEN-CENELEC
Management Centre or to any CENELEC member.
This amendment 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 CEN-CENELEC Management Centre has the same status as
the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden,
Switzerland, Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-43:2010/A1:2018 E
European foreword
The text of document 62B/1012/CDV, future edition 2 of IEC 60601-2-43:2010/A1, 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 approved by CENELEC as EN 60601-2-
43:2010/A1:2018.
The following dates are fixed:
• latest date by which the document has to be implemented at (dop) 2018-11-18
national level by publication of an identical national
standard or by endorsement
(dow) 2021-05-18
• latest date by which the national standards conflicting with
the document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
Endorsement notice
The text of the International Standard IEC 60601-2-43:2010/A1:2017 was approved by CENELEC as
a European Standard without any modification.
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is
available here: www.cenelec.eu.
Annex ZA of EN 60601-2-43:2010 applies, except as follows:
Publication Year Title EN/HD Year
Replace under “Amendment” the existing references to EN 60601-1-2 and EN 60601-1-
3 with the following:
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: General 2015
EN 60601-1-2
requirements for basic safety and essential
performance - Collateral Standard:
Electromagnetic disturbances - Requirements
and tests
IEC 60601-1-3 2008 Medical electrical equipment - Part 1-3: General EN 60601-1-3 2008
IEC 60601-1- 2013 requirements for basic safety and essential EN 60601-1- 2013
3:2008/AMD1 performance - Collateral Standard: Radiation 3:2008/A1:2013
protection in diagnostic X-ray equipment
Publication Year Title EN/HD Year
Add, under “Addition”, the following new references:
IEC 60601-1 2005 Medical electrical equipment - Part 1: General EN 60601-1 2006
IEC 60601- 2012 requirements for basic safety and essential EN 60601- 2013
1:2005/AMD1 performance 1:2006/A1
IEC 61910-1 2014 Medical electrical equipment - Radiation dose EN 61910-1 2014
documentation - Part 1: Radiation dose
structured reports for radiography and
radioscopy
IEC 62220-1-1 2015 Medical electrical equipment - Characteristics EN 62220-1 2015
of digital x-ray imaging devices - Part 1-1:
Determination of the detective quantum
efficiency - Detectors used in radiographic
imaging
Publication Year Title EN/HD Year
Replace, under “Addition”, the existing references to EN 60601-2-54 and to IEC 60788
as follows:
IEC 60601-2-54 2009 Medical electrical equipment - Part 2-54: EN 60601-2-54 2009
IEC 60601-2- 2015 Particular requirements for the basic safety and EN 60601-2- 2015
54:2009/AMD1 essential performance of X-ray equipment for 54:2009/AMD1
radiography and radioscopy
IEC TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
IEC 60601-2-43
Edition 2.0 2017-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –
Part 2-43: Particular requirements for the basic safety and essential performance
of X-ray equipment for interventional procedures
Appareils électromédicaux –
Partie 2-43: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils à rayonnement X lors d’interventions
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50; 37.040.25 ISBN 978-2-8322-4318-3
– 2 – IEC 60601-2-43:2010/AMD1:2017
IEC 2017
FOREWORD
This amendment 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:
CDV Report on voting
62B/1012/CDV 62B/1037/RVC
Full information on the voting for the approval of this amendment can be found in the report
on voting indicated in the above table.
The committee has decided that the contents of this amendment and the base publication will
remain unchanged until the stability date indicated on the IEC website 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.
_____________
INTRODUCTION to the Amendment
The purpose of this first amendment to IEC 60601-2-43:2010 is to introduce changes as
follows:
– refer to IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 and its applicable collateral
standards;
– refer to IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD1:2015 and consequent
subclause adaptations;
– include a requirement to have a maximum time of 10 min to recover all functions after a
recoverable failure in 201.4.101;
– include several aspects from IEC 61910-1:2014 and remove the reference to
IEC PAS 61910-1:2007 in 201.4.102;
– include an alternative way of testing in 201.11.6.5.103;
– include a clarification for tableside controls in 201.12.4.106.
In addition, a number of technical errors have been corrected.
_____________
201.1 Scope, object and related standards
Replace the text of the existing footnote by the following:
IEC 60601-2-43:2010/AMD1:2017 – 3 –
IEC 2017
1) The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance.
201.1.3 Collateral standards
Replace the existing second sentence of the second paragraph by the following:
1) 2) 3)
IEC 60601-1-8, IEC 60601-1-10 , IEC 60601-1-11 and IEC 60601-1-12 do not apply.
201.2 Normative references
Replace, under "Amendment", the existing references to IEC 60601-1-2 and to IEC 60601-1-3
as follows:
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 60601-1-3:2008, 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
Add, under "Addition", the following new references:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 61910-1:2014, Medical electrical equipment – Radiation dose documentation – Part 1:
Radiation dose structured reports for radiography and radioscopy
IEC 62220-1-1:2015, Medical electrical equipment – Characteristics of digital X-ray imaging
devices – Part 1-1: Determination of the detective quantum efficiency – Detectors used in
radiographic imaging
Replace, under "Addition", the existing references to IEC 60601-2-54 and to IEC 60788 as
follows:
IEC 60601-2-54:2009, Medical electrical equipment – Part 2-54: Particular requirements for
the basic safety and essential performance of X-ray equipment for radiography and
radioscopy
IEC 60601-2-54:2009/AMD1:2015
IEC TR 60788:2004, Medical electrical equipment – Glossary of defined terms
___________
1) 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
2)
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
3) 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
– 4 – IEC 60601-2-43:2010/AMD1:2017
IEC 2017
201.3 Terms and definitions
Replace the introductory paragraph by the following new paragraph:
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012, IEC 60601-1-3:2008, IEC 60601-2-54:2009,
IEC TR 60788:2004, IEC 61910-1:2014, IEC 62220-1-1:2015 and the following apply.
Add, after 201.3.203, the following new term and definition:
201.3.204
EMERGENCY RADIOSCOPY
RADIOSCOPY with availability of a limited set of functions (emergency functions), for use during
recovery from a recoverable failure of the INTERVENTIONAL X-RAY EQUIPMENT
201.4.3 ESSENTIAL PERFORMANCE
Replace, in the first sentence, “IEC 60601-2-54:2009” by “IEC 60601-2-54:2009 and
IEC 60601-2-54:2009/AMD1:2015”.
Delete the first sentence of the addition (sentence starting with ‘The list in Table…’).
201.4.101 * Recovery management
Replace the existing text of this subclause by the following new text:
The time to recover all of the functions necessary for performing EMERGENCY RADIOSCOPY,
after a failure recoverable automatically or by the OPERATOR shall be as short as reasonably
practicable. The RISK MANAGEMENT shall take into account the availability of emergency power
supply in the determination of the recovery time.
When the recovery is complete, a
...