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
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 05-Dec-2022

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)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
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

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 60601-2-43:2010/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:
---------------------- Page: 4 ----------------------
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

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
---------------------- Page: 5 ----------------------
– 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.
---------------------- Page: 6 ----------------------
IEC 60601-2-43:2010/AMD1:2017 – 5 –
 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 of the recoverable equipment failure;
– normal operation of the PATIENT SUPPORT;
– normal operation of the gantry;
– normal operation of tableside controls for all functions described above;
– normal operation of the irradiation disabling switch (see 203.6.103);

– normal operation of the motion disabling switch (see 201.9.2.3.1 in IEC 60601-2-54:2009

and IEC 60601-2-54:2009/AMD1:2015);
– normal operation of anti-collision functions (see 201.9.2.4).

Compliance is checked by inspection of the risk management file and by functional tests.

201.4.102 * RADIATION dose documentation
Replace the existing text of this subclause by the following new text:

The INTERVENTIONAL X-RAY EQUIPMENT shall create RADIATION DOSE STRUCTURED REPORTS

(RDSR) and shall have the ability to perform RDSR END OF PROCEDURE TRANSMISSION.

The RDSR shall contain the data elements that are required (‘shall’) in 5.1.2 and 5.1.3 of

IEC 61910-1:2014.

The RDSR should contain the data elements that are recommended (‘should’) in 5.1.2 and

5.1.3 of IEC 61910-1:2014.

NOTE The conditional statements associated with the data elements in IEC 61910-1:2014 are considered to be

part of these data elements.
If the INTERVENTIONAL X-RAY EQUIPMENT does not have means to determine GANTRY

angulations, the RDSR need not contain the data elements related to positioner angles.

Compliance is checked by functional test.
201.7.2.101 Beam limiting device

Replace the reference to “IEC 60601-2-54:2009” by “IEC 60601-2-54:2009 and IEC 60601-2-

54:2009/AMD1:2015”.
201.7.2.105 * Protection against ingress of liquids
Add, after the existing Note 2, the following new note:
NOTE 3 Parts that are IPX0 need not be marked.
201.7.9.2.12 * Cleaning, disinfection and sterilization
Add, after the existing note, the following new subclause:
---------------------- Page: 7 ----------------------
– 6 – IEC 60601-2-43:2010/AMD1:2017
 IEC 2017
201.7.9.2.17 ME EQUIPMENT emitting radiation
Subclause 201.7.9.2.17 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD1:2015
applies.
201.9.2 HAZARDS associated with moving parts
Replace the existing title of this subclause by the following:
201.9.2 MECHANICAL HAZARDS associated with moving parts
Add, before the existing 201.9.2.2.4, the following new title:
201.9.2.2 TRAPPING ZONE
201.9.2.2.4 GUARDS and protective measures
Replace the existing title and text of this subclause by the following:
201.9.2.2.4 GUARDS and other RISK CONTROL measures

Subclause 201.9.2.2.4 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD1:2015 applies.

201.9.2.3 Other HAZARDS associated with moving parts
Replace the existing title and text of this subclause by the following:
201.9.2.3 Other MECHANICAL HAZARDS associated with moving parts

Subclause 201.9.2.3 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD1:2015 applies.

201.11.6.5.101 Footswitches

Replace, in the second paragraph, “a saline solution of at least 0.9 %” by “a saline solution of

at least 0,9 % weight to volume of sodium chloride in water”.
201.11.6.5.103 * ENCLOSURES
Replace the third dash by the following new dash:

– PATIENT SUPPORT should have a minimum degree of protection of IPX2 or should be

protected against spraying water at any angle up to 15° from the vertical.

Renumber the existing Note as NOTE 1, and add, after this note, the following new note:

NOTE 2 For the PATIENT SUPPORT test, the PATIENT SUPPORT can be placed on a 15° slope.

201.11.101 Protection against excessive temperatures of X-RAY TUBE ASSEMBLIES

Replace the reference to “IEC 60601-2-54:2009” by “IEC 60601-2-54:2009 and IEC 60601-2-

54:2009/AMD1:2015”.
201.12 Accuracy of controls and instruments and protection against
hazardous output
201.12.4 * Protection against hazardous output
Add, after the title of this subclause, the following new subclause:
---------------------- Page: 8 ----------------------
IEC 60601-2-43:2010/AMD1:2017 – 7 –
 IEC 2017
201.12.4.5.2 Diagnostic X-ray equipment
Replacement:
INTERVENTIONAL X-RAY EQUIPMENT shall comply with IEC 60601-1-3:2008 and
IEC 60601-1-3:2008/AMD1:2013 as modified by this particular standard.
Compliance is checked as specified in IEC 60601-1-3:2008 and
IEC 60601-1-3:2008/AMD1:2013 as modified by this particular standard.
201.12.4.106 * Tableside controls
Replace the existing text of this subclause by the following new text:

For tableside controls, as a minimum, the following user interface controls, requiring operation

by touch, shall be individually and unambiguously identifiable both by touch alone and also by

sight alone:
– GANTRY and PATIENT SUPPORT motions controls (not including motion controls for
preselecting INTERVENTIONAL X-RAY EQUIPMENT positions);
– IRRADIATION SWITCHES (other than footswitches);
– collimation blade control (not including WEDGE FILTER control).

Collimation blade control may additionally be operated by a duplicated tableside control, such

as a touchscreen user interface.

All tableside controls shall be identifiable under the lighting conditions for the INTENDED USE,

and if applicable, when covered by transparent protective drapes.
Compliance is checked by inspection and by functional tests.

NOTE A tableside control is a control that can be operated adjacent to the PATIENT during a procedure regardless

of whether or not it is physically attached to the PATIENT SUPPORT. A footswitch is not a tableside control for the

purposes of this subclause.
202 Electromagnetic compatibility – Requirements and tests
Replace the existing clause title by the following:
202 Electromagnetic disturbances – Requirements and tests
Replace “IEC 60601-1-2:2007” by “IEC 60601-1-2:2014”.
202.101 Immunity testing of ESSENTIAL PERFORMANCE
Replace the existing text of this subclause by the following sentence:

Subclause 202.101 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD1:2015 applies.

203 Radiation protection in diagnostic X-ray equipment

Replace, in the first paragraph, “IEC 60601-1-3:2008 applies” by “IEC 60601-1-3:2008 and

IEC 60601-1-3:2008/AMD1:2013 apply”.
---------------------- Page: 9 ----------------------
– 8 – IEC 60601-2-43:2010/AMD1:2017
 IEC 2017
203.4.1 Statement of compliance

Replace the existing text after "Replacement" and before "Additional subclause" by the

following:

If, for INTERVENTIONAL X-RAY EQUIPMENT, compliance with this standard is to be stated, the

statement shall be made with the following content:
– model or type reference;
– IEC 60601-2-43:2010.

203.5.2.4.5.101 * Dosimetric information for X-RAY EQUIPMENT specified for RADIOSCOPY

and/or SERIAL RADIOGRAPHY
In item d), last dash, replace “shall by specified” by “shall be specified”.
203.6.4.5 * Dosimetric indications
Replace, in the note, “IEC 60601-2-54:2009” by “IEC 60601-2-54:2009 and
IEC 60601-2-54:2009/AMD1:2015”.

Replace, in the third paragraph, the second, third and fourth dashes by the following:

– The value of the cumulative REFERENCE AIR KERMA resulting from RADIOSCOPY and
RADIOGRAPHY since the last reset operation shall be

• continuously displayed at the working position of the OPERATOR in mGy together with

this unit and updated at least once every 5 s; or
• displayed not later than 5 s after the interruption or termination of LOADING.

– The values for the REFERENCE AIR KERMA RATE and the cumulative REFERENCE AIR KERMA

shall be clearly distinguishable from each other.

The correction to the fifth paragraph starting with "The instructions…" applies to the French

text only.
203.7 RADIATION QUALITY

Replace the reference to “IEC 60601-2-54:2009” by “IEC 60601-2-54:2009 and IEC 60601-2-

54:2009/AMD1:2015”.
Annex AA
Subclause 201.4.101 – Recovery management
Delete the third and fourth paragraphs (both starting with “Less than …”).
Bibliography

Delete the reference [23] to DICOM and the reference [24] to IEC/PAS 61910-1:2007.

Index of defined terms used in this particular standard

Replace, in the existing list, all references to "IEC 60788:2004" by references to

"IEC TR 60788:2004".
Replace the following references as follows:
---------------------- Page: 10 ----------------------
IEC 60601-2-43:2010/AMD1:2017 – 9 –
 IEC 2017

CLEARLY LEGIBLE ........................... IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.15

ESSENTIAL PERFORMANCE ............... IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.27

HARM ............................................ IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.38

HAZARD ......................................... IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.39

HAZARDOUS SITUATION ................... IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.40

INTENDED USE ................................ IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.44

MANUFACTURER ............................. IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.55

NORMAL USE .................................. IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.71

ORIGINAL DATA .................................................................................. IEC 62220-1-1:2015, 3.13

PATIENT ......................................... IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.76

PROCEDURE ................................... IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.88

PROCESS ....................................... IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.89

RISK ............................................ IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.102

RISK MANAGEMENT ....................... IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.107

RISK MANAGEMENT FILE ................. IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.108

SEVERITY ..................................... IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.114

SINGLE FAULT CONDITION .............. IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.116

Add, to the existing list, the following new references:

EMERGENCY RADIOSCOPY ........................................................................................... 201.3.204

GUARD ................................................................................................. IEC 60601-1:2005, 3.36

MECHANICAL HAZARD ............................................................................. IEC 60601-1:2005, 3.61

RADIATION DOSE STRUCTURED REPORT (RDSR)........................................... IEC 61910-1:2014, 3.3

RDSR END OF PROCEDURE TRANSMISSION .................................................. IEC 61910-1:2014, 3.5

RISK CONTROL ................................. IEC 60601-1:2005 et IEC 60601-1:2005/AMD1:2012, 3.105

TRAPPING ZONE ................................................................................... IEC 60601-1:2005, 3.131

___________
---------------------- Page: 11 ----------------------
– 10 – IEC 60601-2-43:2010/AMD1:2017
 IEC 2017
AVANT-PROPOS

Le présent amendement a été établi par le sous-comité 62B: Appareils d'imagerie de

diagnostic, du comité d’études 62 de l'IEC: Équipements électriques dans la pratique

médicale.
Le texte de cet amendement est issu des documents suivants:
CDV Rapport de vote
62B/1012/CDV 62B/1037/RVC

Le rapport de vote indiqué dans le tableau ci-dessus donne toute information sur le vote ayant

abouti à l'approbation de cet amendement.

Le comité a décidé que le contenu de cet amendement et de la publication de base ne sera

pas modifié avant la date de stabilité indiquée sur le site web de l'IEC sous

"http://webstore.iec.ch" dans les données relatives à la publication recherchée. A cette date,

la publication sera
• reconduite,
• supprimée,
• remplacée par une édition révisée, ou
• amendée.
_____________
INTRODUCTION à l'amendement

Ce premier amendement à l’IEC 60601-2-43:2010 a pour but d’introduire les modifications

suivantes:

– référence à l’IEC 60601-1:2005 et à à l’IEC 60601-1:2005/AMD1:2012 et ses normes

collatérales applicables;

– référence à l’IEC 60601-2-54:2009 et à l’IEC 60601-2-54:2009/AMD1:2015 et adaptations

des articles en conséquence;

– intégration d’une exigence relative à un temps maximal de 10 min nécessaire à la reprise

de toutes les fonctions après une défaillance qui peut être traitée, au 201.4.101;

– ajout de plusieurs aspects tirés de l’IEC 61910-1:2014 et suppression de la référence à

l’IEC PAS 61910-1:2007 au 201.4.102;
– intégration d’une méthode alternative d’essai au 201.11.6.5.103;
– ajout d’une clarification relative aux commandes côté table au 201.12.4.106.
De plus, un certain nombre d’erreurs techniques ont été corrigées.
_____________
201.1 Domaine d’application, objet et normes connexes
Remplacer le texte de la note de bas de page existante par la note suivante:
---------------------- Page: 12 ----------------------
IEC 60601-2-43:2010/AMD1:2017 – 11 –
 IEC 2017

1) La norme générale est l’IEC 60601-1:2005 et l'IEC 60601-1:2005/AMD1:2012, Appareils électromédicaux –

Partie 1: Exigences générales pour la sécurité de base et les performances essentielles

201.1.3 Normes collatérales
Remplacer la deuxième phrase existante du deuxième alinéa par le texte suivant:
1) ) )
2 3

L'IEC 60601-1-8, l'IEC 60601-1-10 , l'IEC 60601-1-11 et l'IEC 60601-1-12 ne s’appliquent

pas.
201.2 Références normatives
Remplacer, sous "Amendement", les références existantes à l'IEC 60601-1-2 et à
l'IEC 60601-1-3 par les références suivantes:

IEC 60601-1-2:2014, Appareils électromédicaux – Partie 1-2: Exigences générales pour la

sécurité de base et les performances essentielles – Norme collatérale: Perturbations

électromagnétiques – Exigences et essais

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 à rayonnement X de diagnostic
IEC 60601-1-3:2008/AMD1:2013
Ajouter, sous "Addition", les nouvelles références suivantes:

IEC 60601-1:2005, Appareils électromédicaux – Partie 1: Exigences générales pour la

sécurité de base et les performances essentielles
IEC 60601-1:2005/AMD1:2012

IEC 61910-1:2014, Appareils électromédicaux – Documentation sur la dose de rayonnement –

Partie 1: Rapports structurés sur la dose de rayonnement pour la radiographie et la

radioscopie

IEC 62220-1-1:2015, Appareils électromédicaux – Caractéristiques des dispositifs d'imagerie

à rayonnement X – Partie 1-1: Détermination de l'efficacité quantique de détection –

Détecteurs utilisés en imagerie radiographique

Remplacer, sous "Addition", les références existantes à l'IEC 60601-2-54 et à l'IEC 60788 par

les références suivantes:

IEC 60601-2-54:2009, Appareils électromédicaux – Partie 2-54: Exigences particulières pour

la sécurité de base et les performances essentielles des appareils à rayonnement X utilisés

pour la radiographie et la radioscopie
IEC 60601-2-54:2009/AMD1:2015
IEC T
...