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/A2:2019)

2020-01-08 CV: BT decision (D164/C119) to proceed to publication without link to legislation
2019-11-07 mah: consultant assessment missing: blocked.
2019-11-12 - JO: BT document to remove link to the MDD under review

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

Medicinska električna oprema - 2-43. del: Posebne zahteve za osnovno varnost in bistvene lastnosti rentgenske opreme za interventne postopke - Dopolnilo A2 (IEC 60601-2-43:2010/A2:2019)

General Information

Status
Published
Publication Date
28-Apr-2020
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
22-Apr-2020
Due Date
27-Jun-2020
Completion Date
29-Apr-2020

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SLOVENSKI STANDARD
SIST EN 60601-2-43:2010/A2:2020
01-junij-2020
Medicinska električna oprema - 2-43. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti rentgenske opreme za interventne postopke - Dopolnilo A2 (IEC
60601-2-43:2010/A2:2019)

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/A2:2019)

Appareils électromédicaux - Partie 2-43: Exigences particulières pour la sécurité de base

et les performances essentielles des appareils à rayonnement X lors d’interventions

Ta slovenski standard je istoveten z: EN 60601-2-43:2010/A2:2020
ICS:
11.040.50 Radiografska oprema Radiographic equipment
13.280 Varstvo pred sevanjem Radiation protection
SIST EN 60601-2-43:2010/A2:2020 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 60601-2-43:2010/A2:2020
---------------------- Page: 2 ----------------------
SIST EN 60601-2-43:2010/A2:2020
EUROPEAN STANDARD EN 60601-2-43:2010/A2
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2020
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/A2:2019)
Appareils électromédicaux - Partie 2-43: Exigences To be completed

particulières pour la sécurité de base et les performances (IEC 60601-2-43:2010/A2:2019)

essentielles des appareils à rayonnement X lors
d'interventions
(IEC 60601-2-43:2010/A2:2019)

This amendment A2 modifies the European Standard EN 60601-2-43:2010; it was approved by CENELEC on 2019-11-20. 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the

Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, 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

© 2020 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.

Ref. No. EN 60601-2-43:2010/A2:2020 E
---------------------- Page: 3 ----------------------
SIST EN 60601-2-43:2010/A2:2020
EN 60601-2-43:2010/A2:2020 (E)
European foreword

The text of document 62B/1137/FDIS, future IEC 60601-2-43/A2, 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/A2:2020.
The following dates are fixed:

• latest date by which the document has to be implemented at national (dop) 2020-10-03

level by publication of an identical national standard or by endorsement

• latest date by which the national standards conflicting with the (dow) 2023-04-03

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 shall not be held responsible for identifying any or all such patent rights.

This document has been prepared under a mandate given to CENELEC by the European

Commission and the European Free Trade Association, and supports essential requirements of EU

Directive(s).

For the relationship with EU Directive(s), see informative Annex ZZ, included in EN 60601-2-43:2010.

Endorsement notice

The text of the International Standard IEC 60601-2-43:2010/A2:2019 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 60601-1-8 NOTE Harmonized as EN 60601-1-8
IEC 60601-1-9 NOTE Harmonized as EN 60601-1-9
IEC 60601-1-10 NOTE Harmonized as EN 60601-1-10
IEC 60601-1-12 NOTE Harmonized as EN 60601-1-12
---------------------- Page: 4 ----------------------
SIST EN 60601-2-43:2010/A2:2020
EN 60601-2-43:2010/A2:2020 (E)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements 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 1 Where 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.
The Annex ZA of EN 60601-1:2006 is applicable, except as follows:
Publication Year Title EN/HD Year
Amendment
IEC 60529 1989 Degrees of protection provided by EN 60529 1991
enclosures (IP Code)
+EN 1993
60529:1991/corrige
ndum May 1993
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
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: EN 60601-1-3 2008
General requirements for basic safety and
essential performance - Collateral
Standard: Radiation protection in
diagnostic X-ray equipment
+EN 60601-1-2010
3:2008/corrigendum
Mar. 2010
+A11 2016
Addition
IEC 60580 2000 Medical electrical equipment - Dose area EN 60580 2000
product meters
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
+A12 2014
+EN 60601-2010
1:2006/corrigendum
Mar. 2010
+AC 2014
+A11 2011
---------------------- Page: 5 ----------------------
SIST EN 60601-2-43:2010/A2:2020
EN 60601-2-43:2010/A2:2020 (E)
Publication Year Title EN/HD Year

IEC 60601-2-54 2009 Medical electrical equipment - Part 2-54: EN 60601-2-54 2009

Particular requirements for the basic safety
and essential performance of X-ray
equipment for radiography and radioscopy
IEC 61910-1 2014 Medical electrical equipment - Radiation EN 61910-1 2014
dose documentation - Part 1: Radiation
dose structured reports for radiography
and radioscopy
IEC 62220-1 2003 Medical electrical equipment - EN 62220-1 2004
Characteristics of digital X-ray imaging
devices -- Part 1: Determination of the
detective quantum efficiency
IEC 62220-1-1 2015 Medical electrical equipment - EN 62220-1-1 2015
Characteristics of digital X-ray imaging
devices - Part 1-1: Determination of the
detective quantum efficiency - Detectors
used in radiographic imaging
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
---------------------- Page: 6 ----------------------
SIST EN 60601-2-43:2010/A2:2020
IEC 60601-2-43
Edition 2.0 2019-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
A MENDMENT 2
AM ENDEMENT 2
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 ISBN 978-2-8322-7349-4

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: 7 ----------------------
SIST EN 60601-2-43:2010/A2:2020
– 2 – IEC 60601-2-43:2010/AMD2:2019
 IEC 2019
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:
FDIS Report on voting
62B/1137/FDIS 62B/1146/RVD

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.

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates

that it contains colours which are considered to be useful for the correct

understanding of its contents. Users should therefore print this document using a

colour printer.
___________
INTRODUCTION to Amendment 2

The purpose of this second amendment to IEC 60601-2-43:2010 is to introduce changes as

follows:

– scope clarification with regards to MOBILE X-ray equipment and applicability of

IEC 60601-2-54 subclauses;
– reference to IEC 60601-2-54:2009/AMD2:2018 for common subclauses;

– alignment of 201.7.9.1 with IEC 60601-2-54:2009/AMD2:2018 – 201.7.9.1 is no longer

modified;
– inclusion of adapted requirements or recommendations from
IEC 60601-2-54:2009/AMD2:2018 for
• management of radioscopy image storage in 203.6.1.101,
• display of last image hold (LIH RADIOGRAM) in 203.6.7.101, and
• graphical indication of the boundaries of the X-RAY FIELD in 203.8.102.2;

– inclusion of a recommendation for protection of gantry enclosures in 201.11.6.5.103;

– inclusion of a requirement for X-RADIATION pulse repetition frequency during radioscopy

in 203.6.3.103;
---------------------- Page: 8 ----------------------
SIST EN 60601-2-43:2010/A2:2020
IEC 60601-2-43:2010/AMD2:2019 – 3 –
 IEC 2019

– inclusion of a recommendation for a DOSE MAP in 203.6.4.5 with additional definitions

in 201.3;
– inclusion of a requirement for display unit of dose area product in 203.6.4.5;
– addition of a number of technical clarifications.
__________
201.1.1 Scope

Replace the first sentence of the first existing paragraph by the following new sentence:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of both

FIXED and MOBILE X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for
RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, hereafter referred to as
INTERVENTIONAL X-RAY EQUIPMENT.

Replace the third existing note, including the footnote, by the following new note and footnote:

NOTE 3 INTERVENTIONAL X-RAY EQUIPMENT, when used for cone-beam CT mode, is covered by this standard and

not by IEC 60601-2-44 [2] . No additional requirements for operation in cone-beam CT mode were identified for this

standard (see also Note 4 in 203.6.4.5).
__________
2) Figures in square brackets refer to the Bibliography.
Add, after the fourth existing note, the following new paragraph:

The subclauses of this standard supersede IEC 60601-2-54 subclauses. IEC 60601-2-54

applies only with regards to the cited subclauses; non-cited subclauses of IEC 60601-2-54 do

not apply.
201.1.3 Collateral standards

Replace, in the second existing paragraph, the second sentence, including its corresponding

footnotes, modified by IEC 60601-2-43:2010/AMD1:2017, by the following new sentence and

footnotes:
6 7 8 9 10

IEC 60601-1-8 , IEC 60601-1-9 , IEC 60601-1-10 , IEC 60601-1-11 , IEC 60601-1-12 do

not apply.
__________

6 IEC 60601-1-8, Medical electrical equipment – Part 1-8: General requirements for basic safety and essential

performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical

electrical equipment and medical electrical systems

7 IEC 60601-1-9, Medical electrical equipment – Part 1-9: General requirements for basic safety and essential

performance – Collateral Standard: Requirements for environmentally conscious design

8 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

9 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

10 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: 9 ----------------------
SIST EN 60601-2-43:2010/A2:2020
– 4 – IEC 60601-2-43:2010/AMD2:2019
 IEC 2019
201.2 Normative references
Add, immediately after the instruction "Amendment", the following new reference:
IEC 60529:1989, Degrees of protection provided by enclosures (IP Code)
IEC 60529:1989/AMD1:1999
IEC 60529:1989/AMD2:2013
Replace, under "Addition", the existing reference to IEC 60580 and the one to
IEC 60601-2-54, modified by IEC 60601-2-43:2010/AMD1:2017, by the following new
references:
IEC 60580:2000, Medical electrical equipment – Dose area product meters

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 60601-2-54:2009/AMD2:2018
201.3 Terms and definitions

Replace the first existing paragraph, modified by IEC 60601-2-43:2010/AMD1:2017, by the

following new paragraph:

For the purposes of this document, the terms and definitions given in IEC 60601-1:2005 and

IEC 60601-1:2005/AMD1:2012, IEC 60601-1-3:2008 and IEC 60601-1-3/AMD1:2013,
IEC 60601-2-54:2009, IEC 60601-2-54:2009/AMD1:2015 and IEC 60601-2-

54:2009/AMD2:2018, IEC TR 60788:2004, IEC 61910-1:2014, IEC 62220-1-1:2015 and the

following apply.

Add, after the existing definition 201.3.204, added by IEC 60601-2-43:2010/AMD1:2017, the

following new terms and definitions:
201.3.205
DOSE MAP
representation of the spatial distribution of a RADIATION dose quantity
201.3.206
SKIN DOSE
estimated ABSORBED DOSE to the skin at a specific point
201.3.207
SKIN DOSE MAP
DOSE MAP of the SKIN DOSE
201.4.102 RADIATION dose documentation

Add, at the end of the paragraph, modified by IEC 60601-2-43:2010/AMD1:2017, but before

the compliance statement, the following new paragraph:
The data elements shall be populated with the specified data.

Replace the existing compliance statement by the following new compliance statement:

Compliance is checked by appropriate inspection and functional test.
---------------------- Page: 10 ----------------------
SIST EN 60601-2-43:2010/A2:2020
IEC 60601-2-43:2010/AMD2:2019 – 5 –
 IEC 2019
201.5 General requirements for testing of ME EQUIPMENT
Replace the existing text by the following new text:
Clause 5 of the general standard applies, except as follows:
201.5.7 Humidity preconditioning treatment
Addition:

For INTERVENTIONAL X-RAY EQUIPMENT that is to be used only in controlled environments, as

specified in the ACCOMPANYING DOCUMENTS, no humidity preconditioning treatment is required.

The ACCOMPANYING DOCUMENTS shall include the time period that the room environmental

operating conditions need to be maintained prior to powering the system on.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
201.7.2.104 Marking of compliance

Replace, in the second existing paragraph, the reference "IEC 60601-2-43:2010" by

"IEC 60601-2-43:2010, IEC 60601-2-43:2010/AMD1:2017, IEC 60601-2-43:2010/AMD2:2019".

201.7.2.105 Protection against ingress of liquids

Replace, in the existing paragraph, the reference "IEC 60529" by "IEC 60529:1989,

IEC 60529:1989/AMD1:1999 and IEC 60529:1989/AMD2:2013".
201.7.9.1 General
Replace the existing text by the following new text:

Subclause 201.7.9.1 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD2:2018 applies.

201.7.9.101 Additional statements in ACCOMPANYING DOCUMENTS
Table 201.102 – Other subclauses requiring statements in ACCOMPANYING DOCUMENTS
Add, after the last row, the following new rows:
201.5.7 Humidity preconditioning treatment
201.11.6.5.103 ENCLOSURES
203.5.2.4.102 EXAMINATION PROTOCOLS
203.6.4.5 Dosimetric indications
Add, after Table 201.102, the following new note:

NOTE While Table 201.C.102 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD2:2018 lists the following

subclauses "203.6.4.5 Dosimetric indications" and "203.5.2.4.5.101 Dosimetric information for X-RAY EQUIPMENT

specified for RADIOSCOPY and/or SERIAL RADIOGRAPHY", the corresponding requirements for statements in

ACCOMPANYING DOCUMENTS are located in this standard and not in IEC 60601-2-54:2009 and its amendments.

201.8 Protection against electrical HAZARDS from ME EQUIPMENT

Delete the sentence: "Clause 8 of the general standard applies, except as follows:"

---------------------- Page: 11 ----------------------
SIST EN 60601-2-43:2010/A2:2020
– 6 – IEC 60601-2-43:2010/AMD2:2019
 IEC 2019
201.9.8 HAZARDS associated with support systems
Replace the existing title of this subclause by the following new title:
201.9.8 MECHANICAL HAZARDS associated with support systems
201.9.8.3.3 Dynamic forces due to loading from persons

Replace, in the existing paragraph, the reference "IEC 60601-2-54:2009" by "IEC 60601-2-

54:2009 and IEC 60601-2-54:2009/AMD2:2018".
201.10 Protection against unwanted and excessive radiation HAZARDS

Replace the existing paragraph, excluding the note, by the following new paragraph:

Clause 201.10 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD2:2018 applies.
201.11 Protection against excessive temperatures and other HAZARDS
201.11.6.5.103 ENCLOSURES

Add, in the first existing paragraph, the following new sentence to the third dash, modified by

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

For the PATIENT SUPPORT test, testing may be considered sufficient by angulating the PATIENT

SUPPORT 15° from the horizontal position.
Add, in the first existing paragraph, the following item to the dash list:

– X-RAY TUBE ASSEMBLY and associated GANTRY elements should have a minimum degree of

protection of IPX2, except for INTERVENTIONAL X-RAY EQUIPMENT with a FIXED over-table X-

RAY SOURCE ASSEMBLY. The ACCOMPANYING DOCUMENTS shall describe the associated
GANTRY elements that are included within the IPX2 classification. Testing may be

considered sufficient by tilting the C-arm in the least favourable position with a maximum

of 15° in any direction from the vertical position.
Replace, in the second paragraph, the reference "IEC 60529" by "IEC 60529:1989,
IEC 60529:1989/AMD1:1999 and IEC 60529:1989/AMD2:2013".
Replace "NOTE 1" by "NOTE".
Delete the second note.
Add, after 201.11.6.5.103, the following new text:
201.11.8 Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT

Subclause 201.11.8 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD2:2018 applies.

201.12 Accuracy of controls and instruments and protection against
hazardous outputs

Replace, in the note, the reference "under 203.6.4.3 of IEC 60601-2-54:2009" by "under

203.6.4.3 of this document".
---------------------- Page: 12 ----------------------
SIST EN 60601-2-43:2010/A2:2020
IEC 60601-2-43:2010/AMD2:2019 – 7 –
 IEC 2019
201.16 ME SYSTEMS
Replace the existing text by the following new text:
Clause 16 of the general standard applies, except as follows:
201.16.8 Interruption of the power supply to parts of an ME SYSTEM
Replacement:

Subclause 201.16.8 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD2:2018 applies.

203.4.1 Statement of compliance

Replace, in the existing paragraph, modified by IEC 60601-2-43:2010/AMD1:2017, the

reference "IEC 60601-2-43:2010" by "IEC 60601-2-43:2010, IEC 60601-2-
43:2010/AMD1:2017 and IEC 60601-2-43:2010/AMD2:2019".
Add, after the existing 203.4.101, the following new text:
203.5.2.1 References in subclauses
Table 2 – Subclauses requiring statements in ACCOMPANYING DOCUMENTS
Amendment:
The row about Clinical protocols, Subclause 5.2.4.4, does not apply.
203.5.2.4 Instructions for use
Add, after the existing 203.5.2.4, the following new subclause:
203.5.2.4.4 Clinical protocols
Subclause 5.2.4.4 of IEC 60601-1-3:2008 does not apply.
203.5.2.4.5.102 Test for dosimetric information
Replace, in the last paragraph, "NOTE 2" by "NOTE".
Add, after the existing 203.5.2.4.101, the following new subclause:
203.5.2.4.102 EXAMINATION PROTOCOLS
Subclause 203.5.2.4.101 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD2:2018
applies.
NOTE The numbering of the cited subclause from IEC 60601-2-54 is different.
Add, after the existing 203.6, the following new text:
203.6.1 General
Additional subclauses:
---------------------- Page: 13 ----------------------
SIST EN 60601-2-43:2010/A2:2020
– 8 – IEC 60601-2-43:2010/AMD2:2019
 IEC 2019
203.6.1.101 Management of RADIOSCOPY image storage

NTERVENTIONAL X-RAY EQUIPMENT shall provide the capability to store a RADIOSCOPY REPLAY

IMAGE SEQUENCE for display. This capability may be limited to storage of images as follows:

RADIOSCOPY;
– at pulse rates up to 10 pulses per second, the last 30 s of
– for pulse rates greater than 10 pulses per second, the last 300 images;
RADIOSCOPY, the last 10 s of RADIOSCOPY.
– for continuous

This requirement does not apply to MOBILE X-RAY EQUIPMENT with a maximum FOCAL SPOT TO

less than 45 cm and that is specified for extremities use only in its
IMAGE RECEPTOR DISTANCE
INTENDED USE.
NOTE The storage is not required to be a permanent storage.
Compliance is checked by functional test.
203.6.1.102 Management of EXAMINATION PROTOCOLS
Subclause 203.6.1.102 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD2:2018
applies.
203.6.2 Initiation and termination of the IRRADIATION

Replace, in the existing paragraph, the reference "IEC 60601-2-54:2009" by "IEC 60601-2-

54:2009 and IEC 60601-2-54:2009/AMD2:2018".
203.6.3 RADIATION dose and RADIATION QUALITY
203.6.3.2 Reproducibility of the RADIATION output

Replace, in the existing paragraph, the reference "IEC 60601-2-54:2009" by "IEC 60601-2-

54:2009 and IEC 60601-2-54:2009/AMD2:2018".
Add, after the existing 203.6.3.102, the following new subclause:
203.6.3.103 * X-RADIATION pulse repetition frequency during RADIOSCOPY

If the RADIOSCOPY pulse rate is selectable, the minimum pulse rate shall be less than or equal

to 4 pulses per second.
203.6.4.3 Indication of LOADING FACTORS and MODES OF OPERATION

Replace, in the existing paragraph, the reference "IEC 60601-2-54:2009" by "IEC 60601-2-

54:2009 and IEC 60601-2-54:2009/AMD2:2018".
203.6.4.5 * Dosimetric indications
Replace the existing note by the following new note:

NOTE 1 Differences related to the same subclause in IEC 60601-2-54:2009, IEC 60601-2-54:2009/AMD1:2015

st rd

and IEC 60601-2-54:2009/AMD2:2018 include: the 1 dash of the 3 paragraph is applicable also to SERIAL

th 2 2

RADIOGRAPHY; in the 4 paragraph, the minimal value is 2,5 Gy⋅cm instead of 5 µGy⋅m , i.e. is 50 times larger; the

DOSE AREA PRODUCT is Gy⋅cm ; a requirement to have means for configuring
recommended unit for displaying the

the display unit of the DOSE AREA PRODUCT is present; additional requirements and recommendations are present

after the requirement about DOSE AREA PRODUCT METERS, including additional requirement and recommendation

about DOSE MAP and SKIN DOSE MAP; and also, unlike in IEC 60601-2-54, there is no specific requirement for

INDIRECT RADIOGRAPHY and DIRECT RADIOGRAPHY.

Add, in the third existing paragraph after the note, the following dashed item to the list:

---------------------- Page: 14 ----------------------
SIST EN 60601-2-43:2010/A2:2020
IEC 60601-2-43:2010/AMD2:2019 – 9 –
 IEC 2019

– The displayed values of REFERENCE AIR KERMA RATE and cumulative REFERENCE AIR KERMA

may be measured or calculated.

Add, in the fourth paragraph after the note, the following new text after the third sentence:

Means shall be provided to the RESPONSIBLE ORGANIZATION to allow configuring the unit for

display of DOSE AREA PRODUCT at least among all the following:
– Gy⋅cm ;
2 2
– µGy⋅m or cGy⋅cm ;
– mGy⋅cm .

The instructions for use shall indicate that the unit for display of DOSE AREA PRODUCT is

configurable.
Delete, in the fourth paragraph after the note, the last sentence.
Add, after the fourth paragraph after the note, the following new paragraph:

The overall uncertainty of the displayed values of the cumulative DOSE AREA PRODUCT above

2,50 Gy⋅cm shall not exceed 35 %.
Add, before the compliance statement, the following new text:
The INTERVENTIONAL X-RAY EQUIPMENT should have a DOSE MAP.

NOTE 2 If a DOSE MAP is provided, it is intended for display during the procedure and to be available for export at

the end of the procedure.

NOTE 3 A SKIN DOSE MAP is preferred over other DOSE MAPS. An example of a DOSE MAP can be obtained by

cumulating the values of REFERENCE AIR KERMA over ranges of the available parameters that influence the location

of the X-RAY BEAM relative to the PATIENT. When the INTERVENTIONAL X-RAY EQUIPMENT cannot determine the

orientation of the X-RAY BEAM AXIS, creation of a DOSE MAP is not practical. Mapping head, chest, abdomen and

pelvic anatomy is of primary value; mapping extremities is of secondary value due to smaller body part thickness

and their variability in position on the PATIENT SUPPORT.

A DOSE MAP shall not be designated as a SKIN DOSE MAP, unless the RADIATION dose quantity is

SKIN DOSE.

NOTE 4 Dosimetric indications apply also for operation in cone-beam CT mode. This provides a means to

combine the RADIATION dose for all MODES OF OPERATIONS.
203.6.5 AUTOMATIC CONTROL SYSTEM

Replace, in the existing paragraph, the reference "IEC 60601-2-54:2009" by "IEC 60601-2-

54:2009 and IEC 60601-2-54:2009/AMD2:2018".
203.6.6 SCATTERED RADIATION reduction

Replace, in the first sentence of the subclause, the reference "IEC 60601-2-54:2009" by

"IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD2:2018".
203.6.7 Imaging performance
Replace the existing paragraph by the following new text:
Additional subclause:
---------------------- Page: 15 ----------------------
SIST EN 60601-2-43:2010/A2:2020
– 10 – IEC 60601-2-43:2010/AMD2:2019
 IEC 2019
203.6.7.101 * Display of LAST IMAGE HOLD RADIOGRAM or RADIOSCOPY REPLAY IMAGE
SEQUENCE

INTERVENTIONAL X-RAY EQUIPMENT shall be equipped with means to display either a LIH

RADIOGRAM or a RADIOSCOPY REPLAY IMAGE SEQUENCE following termination of the radioscopic

IRRADIATION and shall comply with the following.

1) When the LIH RADIOGRAM is displayed, it shall be displayed following termination of the

radioscopic IRRADIATION and shall remain visible either until an action by the OPERATOR or

until display of the RADIOSCOPY REPLAY IMAGE SEQUENCE.

2) Means shall be provided to clearly indicate to the OPERATOR whether a displayed image is

– a LIH RADIOGRAM or a RADIOSCOPY REPLAY IMAGE SEQUENCE, or
– from ongoing RADIOSCOPY.

3) Display of the LIH RADIOGRAM or the RADIOSCOPY REPLAY IMAGE SEQUENCE shall be replaced

by the RADIOSCOPY image concurrently with reinitiation of radioscopic IRRADIATION, unless

DISPLAY is provided for the RADIOSCOPY images.
a separate

4) For a LIH RADIOGRAM obtained by retaining pre-termination RADIOSCOPY images, if the

number of images and method of combining images are selectable by the OPERATOR, the

selection shall be indicated prior to initiation of the radioscopic IRRADIATION.
Compliance is checked by inspection and functional tests.
203.7 RADIATION QUALITY

Replace, in the existing paragraph, modified by IEC 60601-2-43:2010/AMD1:2017, the

reference "IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD1:2015" by "IEC 60601-2-

54:2009, IEC 60601-2-54:2009/AMD1:2015 and IEC 60601-2-54:2009/AMD2:2018".
203.8.102 Methods of beam limitation in X-RAY EQUIPMENT
Replace the existing paragraph by the following new text:
Additional subclauses:
203.8.102.1 General
Subclause 203.8.102.1 of IEC 60601-2-54:2009 applies.
203.8.102.2 Indication on th
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