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/A2:2018)

2019-04-04-JO-: link to legislation and mandate M/295 removed following CLC/BT decision D162/C076
2018-10-31: Lack of compliance from the HAS consultant
2018-08-23 : Consultant's assessment is missing.
in-check - 2018-07-12 - Consultant's assessment is rejected at CDV stage.

Medizinische elektrische Geräte - Teil 2-54: Besondere Festlegungen für die Sicherheit und die wesentlichen Leistungsmerkmale von Röntgeneinrichtungen für Radiographie und Radioskopie (IEC 60601-2-54:2009/A2:2018)

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/A2:2018)

Medicinska električna oprema - 2-54. del: Posebne zahteve za osnovno varnost in bistvene lastnosti rentgenske opreme za radiografijo in radioskopijo - Dopolnilo A2 (IEC 60601-2-54:2009/A2:2018)

General Information

Status
Published
Publication Date
05-Jun-2019
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
30-May-2019
Due Date
04-Aug-2019
Completion Date
06-Jun-2019

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SLOVENSKI STANDARD
SIST EN 60601-2-54:2009/A2:2019
01-julij-2019
Medicinska električna oprema - 2-54. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti rentgenske opreme za radiografijo in radioskopijo - Dopolnilo
A2 (IEC 60601-2-54:2009/A2:2018)

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/A2:2018)

Medizinische elektrische Geräte - Teil 2-54: Besondere Festlegungen für die Sicherheit

und die wesentlichen Leistungsmerkmale von Röntgeneinrichtungen für Radiographie
und Radioskopie (IEC 60601-2-54:2009/A2:2018)

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/A2:2018)
Ta slovenski standard je istoveten z: EN 60601-2-54:2009/A2:2019
ICS:
11.040.50 Radiografska oprema Radiographic equipment
SIST EN 60601-2-54:2009/A2:2019 en

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

---------------------- Page: 1 ----------------------
SIST EN 60601-2-54:2009/A2:2019
---------------------- Page: 2 ----------------------
SIST EN 60601-2-54:2009/A2:2019
EUROPEAN STANDARD EN 60601-2-54:2009/A2
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2019
ICS 11.040.50
English Version
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/A2:2018)

Appareils électromédicaux - Partie 2-54: Exigences Medizinische elektrische Geräte - Teil 2-54: Besondere

particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit und die wesentlichen

essentielles des appareils à rayonnement X utilisés pour la Leistungsmerkmale von Röntgeneinrichtungen für

radiographie et la radioscopie Radiographie und Radioskopie
(IEC 60601-2-54:2009/A2:2018) (IEC 60601-2-54:2009/A2:2018)

This amendment A2 modifies the European Standard EN 60601-2-54:2009; it was approved by CENELEC on 2018-08-03. 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

© 2019 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.

Ref. No. EN 60601-2-54:2009/A2:2019 E
---------------------- Page: 3 ----------------------
SIST EN 60601-2-54:2009/A2:2019
EN 60601-2-54:2009/A2:2019 (E)
European foreword

The text of document 62B/1089/FDIS, future IEC 60601-2-54/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 60601-2-54:2009/A2:2019.
The following dates are fixed:

• latest date by which the document has to be implemented at national (dop) 2019-11-24

level by publication of an identical national standard or by endorsement

• latest date by which the national standards conflicting with the (dow) 2022-05-24

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.

Endorsement notice

The text of the International Standard IEC 60601-2-54:2009/A2:2018 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 62220-1-3:2008 NOTE Harmonized as EN 62220-1-3:2008 (not modified)
IEC 62563-1:2009 NOTE Harmonized as EN 62563-1:2010 (not modified)
IEC 60601-1-9 NOTE Harmonized as EN 60601-1-9
---------------------- Page: 4 ----------------------
SIST EN 60601-2-54:2009/A2:2019
EN 60601-2-54:2009/A2:2019 (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.
Annex ZA of EN 60601-2-54:2009 applies, except as follows:
Publication Year Title EN/HD Year
Replacement
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
Addition
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 62494-1 2008 Medical electrical equipment - Exposure EN 62494-1 2008
index of digital X-ray imaging systems -
Part 1: Definitions and requirements for
general radiography
---------------------- Page: 5 ----------------------
SIST EN 60601-2-54:2009/A2:2019
---------------------- Page: 6 ----------------------
SIST EN 60601-2-54:2009/A2:2019
IEC 60601-2-54
Edition 1.0 2018-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AM ENDMENT 2
AM ENDEMENT 2
Medical electrical equipment –

Part 2-54: Particular requirements for the basic safety and essential performance

of X-ray equipment for radiography and radioscopy
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
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-5758-6

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 60601-2-54:2009/A2:2019
– 2 – IEC 60601-2-54:2009/AMD2:2018
© IEC 2018
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/1089/FDIS 62B/1097/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.
_____________
INTRODUCTION TO AMENDMENT 2

The purpose of this second amendment to IEC 60601-2-54:2009 is to introduce changes

which take the current state of the art into account. Therefore, X-RAY EQUIPMENT specified for

DIRECT RADIOSCOPY is no longer in the scope of this document. The normative references were

also updated in this amendment, and editorial clarifications and new terms and definitions

were added. Provisions for QUALITY CONTROL PROCEDURES to be recommended by the

MANUFACTURER are emphasized. Specific attention is paid to EXAMINATION PROTOCOLS in a new

subclause which differentiate between adult and paediatric applications, in particular for

X-RAY EQUIPMENT without an AUTOMATIC CONTROL SYSTEM. In addition, fixed periods for

termination of LOADING after release of the RADIATION control by the OPERATOR are stipulated

for RADIOSCOPY.

A new subclause on electronic documentation of EXAMINATION PROTOCOLS is introduced. It

recommends providing access to electronic documentation containing relevant parameters of

the PRE-PROGRAMMED EXAMINATION PROTOCOL. In another new subclause, the creation of basic

documentation of the RADIATION DOSE STRUCTURED REPORT (RDSR) according to IEC 61910-1 is

recommended. Furthermore, the subclause describing the LAST IMAGE HOLD RADIOGRAM has

been revised and requires that the last image in RADIOSCOPY be displayed rather than provide

just a means to display it.

This amendment recommends providing a graphical DISPLAY of the position of the BEAM

LIMITING DEVICE blades on the IMAGE DISPLAY DEVICE in the subclause "Indication on the X-RAY

EQUIPMENT".
---------------------- Page: 8 ----------------------
SIST EN 60601-2-54:2009/A2:2019
IEC 60601-2-54:2009/AMD2:2018 – 3 –
© IEC 2018

Finally, the requirement for providing means to limit the FOCAL SPOT TO SKIN DISTANCES for

radioscopic X-RAY EQUIPMENT differentiates between MOBILE and FIXED EQUIPMENT and

extends, in the latter case, the minimum distance in possible clinical applications.

201.1.1 Scope

Replace, in the first paragraph, the first existing sentence by the following new sentence:

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

EQUIPMENT and ME SYSTEMS intended to be used for projection RADIOGRAPHY and INDIRECT

RADIOSCOPY.
Replace the second existing paragraph by the following new paragraph:
ME EQUIPMENT and ME SYSTEMS intended to be used for bone or tissue absorption

densitometry, computed tomography, mammography, dental or radiotherapy applications are

excluded from the scope of this International Standard.
Delete the note.
201.1.3 Collateral standards
Replace the second paragraph, modified by IEC 60601-2-54:2009/AMD1:2015, by the
following new paragraph:

IEC 60601-1-2 and IEC 60601-1-3 apply as modified in Clauses 202 and 203 respectively.

IEC 60601-1-8, IEC 60601-1-9, IEC 60601-1-10, IEC 60601-1-11 and IEC 60601-1-12 do not

apply. All other published collateral standards in the IEC 60601-1 series apply as published.

201.2 Normative references

Replace the existing reference to IEC 62220-1:2003 by the following new reference:

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

IEC 61910-1:2014, Medical electrical equipment – Radiation dose documentation – Part 1:

Radiation dose structured reports for radiography and radioscopy

IEC 62494-1:2008, Medical electrical equipment – Exposure index of digital X-ray imaging

systems – Part 1: Definitions and requirements for general radiography
201.3 Terms and definitions

Add, after the existing definition 201.3.209, the following new terms and definitions:

201.3.210
EXAMINATION PROTOCOL

full set of any programmed technical factors, control functions and settings, including image

processing settings, designed to optimize the image acquisition and DISPLAY
---------------------- Page: 9 ----------------------
SIST EN 60601-2-54:2009/A2:2019
– 4 – IEC 60601-2-54:2009/AMD2:2018
© IEC 2018
201.3.211
EXAMINATION PROTOCOL SELECTION CONTROL
control to select a PRE-PROGRAMMED EXAMINATION PROTOCOL
201.3.212
LAST-IMAGE HOLD RADIOGRAM
LIH RADIOGRAM

single image obtained by sampling or temporal processing of one or more images from the

end of a radioscopic IRRADIATION
Note 1 to entry: This note applies to the French language only.
201.3.213
PRE-PROGRAMMED EXAMINATION PROTOCOL

single hardware or software setting, or both, which is associated with an EXAMINATION

PROTOCOL
201.3.214
RADIOSCOPY REPLAY IMAGE SEQUENCE
series of the most recent images of the most recent RADIOSCOPY IRRADIATION-EVENT
201.7.9.1 General

Replace the first paragraph after "Addition:" by the following new paragraph and note:

The ACCOMPANYING DOCUMENTS shall contain instructions for MANUFACTURER-recommended

QUALITY CONTROL PROCEDURES and tests to be performed on the X-RAY EQUIPMENT by the

RESPONSIBLE ORGANIZATION. These shall include acceptance criteria for each test and

frequency for each test.

NOTE The intention is to perform these QUALITY CONTROL PROCEDURES and tests using only the supplied

information.
Replace the first dash in the second paragraph by the following new dash:

– an identification of adjustable or selectable image processing settings applied to ORIGINAL

DATA including the version number or how to determine it;

Add, before the compliance statement at the end of this subclause, the following new

paragraph:

If the test or PROCEDURE requires a device-specific TOOL that is only available from the

MANUFACTURER, the MANUFACTURER shall make this TOOL available to the RESPONSIBLE
ORGANIZATION.
201.7.9.3.101 X-RAY SOURCE ASSEMBLY
Replace, at the end of the item a), the colon by a semicolon.
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 the paragraph starting with "Where mechanical analysis…" by the following new

paragraph:
---------------------- Page: 10 ----------------------
SIST EN 60601-2-54:2009/A2:2019
IEC 60601-2-54:2009/AMD2:2018 – 5 –
© IEC 2018

Where mechanical analysis proves that the following alternate static load test is more severe

than the dynamic load test specified in the general standard, it is possible to waive the

dynamic load test based on RISK MANAGEMENT. If the dynamic load test is passed, the static

test may not be necessary.
201.10 Protection against unwanted and excessive radiation HAZARDS
Replace the existing text of this clause by the following new text:

Clause 10 of the general standard applies, except Subclause 10.3 (Microwave radiation),

which does not apply.
201.11 Protection against excessive temperatures and other HAZARDS

Add, before the instruction "Additional subclauses", the following new subclauses:

201.11.1.1 Maximum temperature during NORMAL USE
Addition:

NOTE Restrictions on allowable maximum temperature in Table 22 of the general standard for parts in contact

with oil shall not apply to parts wholly immersed in oil.
201.11.8 Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT
Replacement of the first paragraph modified by IEC 60601-1:2005/AMD1:2012:

ME EQUIPMENT shall be so designed that an interruption and restoration of the power supply

shall not result in the loss of BASIC SAFETY and that restoration of the power shall not result in

the loss of ESSENTIAL PERFORMANCE.
201.12 Accuracy of controls and instruments and protection against
hazardous outputs
Replace the existing text of this clause by the following new text:
Clause 12 of the general standard applies, except as follows:
Addition:

NOTE According to subclause 12.4.5 of the general standard, the dose related aspects of this question are

addressed under 203.6.4.3 of this document.
201.16 ME SYSTEMS
Replace the existing text of this clause 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 of the first paragraph modified by IEC 60601-1:2005/AMD1:2012:

An ME SYSTEM shall be so designed that an interruption and restoration of the power to the ME

SYSTEM as a whole, or any part of the ME SYSTEM, shall not result in the loss of BASIC SAFETY

and that restoration of the power shall not result in the loss of ESSENTIAL PERFORMANCE.

---------------------- Page: 11 ----------------------
SIST EN 60601-2-54:2009/A2:2019
– 6 – IEC 60601-2-54:2009/AMD2:2018
© IEC 2018
202.101 Immunity testing of ESSENTIAL PERFORMANCE
Replace the existing title of this subclause by the following new title:
202.101 *Immunity testing of ESSENTIAL PERFORMANCE
E EQUIPMENT identification, marking and documents
203.5 M
Add, before the existing 203.5.2.4.5, the following new text:
203.5.2.1 References in subclauses
Amendment:

In Table 2 of IEC 60601-1-3:2008, the line about Clinical protocols, Subclause 5.2.4.4, does

not apply.
203.5.2.4 Instructions for use
203.5.2.4.4 Clinical protocols
Subclause 5.2.4.4 of IEC 60601-1-3:2008 does not apply.
Additional subclause:
203.5.2.4.101 EXAMINATION PROTOCOLS

When EXAMINATION PROTOCOLS are proposed by the MANUFACTURER, and preloaded on the

EQUIPMENT, the instructions for use shall state if they constitute recommendations to be

applied directly so as to allow optimized operation or if they are only examples/starting points,

to be replaced by more specific protocols developed by the RESPONSIBLE ORGANIZATION.

Compliance is checked by inspection of the instructions for use.
203.6 Radiation management
Add, after the existing title of 203.6, the following new subclauses:
203.6.1 General
Additional subclauses:
203.6.1.101 Management of RADIOSCOPY image storage
X-RAY EQUIPMENT specified for RADIOSCOPY should provide the capability to store

a RADIOSCOPY REPLAY IMAGE SEQUENCE for DISPLAY. This capability may be limited to storage of

images as follows:
• at pulse rates up to 10 pulses per second, the last 30 seconds of RADIOSCOPY;
• for pulse rates greater than 10 pulses per second, the last 300 images;
• for continuous RADIOSCOPY, the last 10 seconds of RADIOSCOPY.
Compliance is checked by functional test.
---------------------- Page: 12 ----------------------
SIST EN 60601-2-54:2009/A2:2019
IEC 60601-2-54:2009/AMD2:2018 – 7 –
© IEC 2018
203.6.1.102 Management of EXAMINATION PROTOCOLS

EXAMINATION PROTOCOLS are preloaded and the INTENDED USE of the X-RAY EQUIPMENT covers

both adult and paediatric applications, the designation of these protocols shall clearly

distinguish between adult and paediatric applications.
For equipment without an automatic control system:

– at least three PATIENT size choices should be selectable by the OPERATOR for adult

PATIENTS;

INTENDED USE includes paediatric applications, at least three PATIENT size choices

– If the
should be selectable by the OPERATOR for paediatric PATIENTS.
Compliance is checked by inspection or by the appropriate functional tests.
203.6.2.1 Normal initiation and termination of the IRRADIATION
Add, at the end of the existing list, the following new item:

e) *For a RADIOSCOPY IRRADIATION-EVENT of more than 0,5 s, the X-RAY EQUIPMENT shall

LOADING within 0,1 s from the time the OPERATOR releases the control
terminate the

(e.g., by releasing pressure on a foot pedal).The shortest possible time is desirable.

For a RADIOSCOPY IRRADIATION-EVENT of 0,5 s or less, the X-RAY EQUIPMENT shall terminate

the LOADING within 0,5 s from the time the OPERATOR releases the control (e.g., by

releasing pressure on a foot pedal).

The instructions for use shall indicate the RADIOSCOPY IRRADIATION-EVENT times for which

RADIOSCOPY can continue after the control is released, as described in 203.6.2.1 e), and the

maximum amount of time that RADIOSCOPY can continue in each of the described cases.

203.6.3.2.102 Linearity and constancy in RADIOGRAPHY
Replace the existing item b) by the following new item b):
AUTOMATIC EXPOSURE CONTROLS for DIRECT RADIOGRAPHY
b) Reproducibility of
In the operation of an AUTOMATIC EXPOSURE CONTROL in RADIOGRAPHY to control

IRRADIATION for DIRECT RADIOGRAPHY, the reproducibility shall comply with the following

requirements, either

– the coefficient of variation of MEASURED VALUES of AIR KERMA shall be not greater than

0,05; or
RADIOGRAMS shall not exceed a value of
– the variation of optical density in the resultant
0,10 for unchanged X-RAY TUBE VOLTAGE and constant thickness of the irradiated
object.
Compliance is checked by the following test PROCEDURES:
I) Compliance of coefficient of variation of MEASURED VALUES OF AIR KERMA:
– Test conditions
Use the test conditions according to subclause 203.6.3.2.103 with an X-RAY TUBE
VOLTAGE representative of the specified INTENDED
...

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