IEC 60601-2-43:2010/AMD1:2017

Amendment 1 - Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures

Amendement 1 - Appareils électromédicaux - Partie 2-43: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X lors d'interventions

General Information

• Status: Published
• Publication Date: 30-May-2017
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.50 - Radiographic equipment
• ICS: 37.040.25 - Radiographic films
• Technical Committee: SC 62B - Medical imaging equipment, software, and systems
• Drafting Committee: MT 41 - TC 62/SC 62B/MT 41
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 05-Dec-2022

Relations

• Amends: IEC 60601-2-43:2010 - Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
• Effective Date: 05-Sep-2023
• Revised: IEC 60601-2-43:2022 - Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
• Effective Date: 05-Sep-2023

Standards Content (Sample)

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

IEC 60601-2-43:2010-03/AMD1:2017-05(en-fr)

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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 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 reinitiation of IRRADIATION shall be required to produce
further IRRADIATION.
The time to recover all functions, after a failure recoverable automatically or by the operator,
shall be as short as reasonably practicable.
In case of a manually recoverable failure, the time to recover all functions shall not exceed
10 min from the time the OPERATOR has initiated the recovery to the time the INTERVENTIONAL
X-RAY EQUIPMENT has all functions available.
In case of an automatically detected and automatically recoverable failure, the time to recover
all functions shall not exceed 10 min from the time of the failure of the INTERVENTIONAL X-RAY
to the time the INTERVENTIONAL X-RAY EQUIPMENT has all functions available.
EQUIPMENT
INTERVENTIONAL X-RAY EQUIPMENT may have both recovery modes.
NOTE Less than 1 min is a desirable value for the time to recover all functions for performing EMERGENCY
RADIOSCOPY. Less than 3 min is a desirable value to recover all functions.
The instructions for use shall indicate:
– the time necessary to get all functions for EMERGENCY RADIOSCOPY operable;
– the time to restore all functions of the INTERVENTIONAL X-RAY EQUIPMENT;
– for failures recoverable by the OPERATOR, the required procedure which the OPERATOR
must follow to perform this recovery.

 IEC 2017
When the system is in the EMERGENCY RADIOSCOPY mode, this mode shall be indicated at the
working position of the OPERATOR.
The functions necessary for performing EMERGENCY RADIOSCOPY shall include, at minimum:
– RADIOSCOPY MODE OF OPERATION, in priority order:
• RADIOSCOPY in the MODE OF OPERATION that was used at the time of the recoverable
equipment failure;
• or, if this is not possible, RADIOSCOPY in the MODE OF OPERATION as close as possible to
the one which was used at the time o
...