SIST EN 60601-2-54:2009/A1:2015

Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

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Medizinische elektrische Geräte - Teil 2-54: Besondere Festlegungen für die Sicherheit und die wesentlichen Leistungsmerkmale von Röntgeneinrichtungen für Radiographie und Radioskopie

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

Medicinska električna oprema - 2-54. del: Posebne zahteve za osnovno varnost in bistvene lastnosti rentgenske opreme za radiografijo in radioskopijo - Dopolnilo A1

General Information

• Status: Published
• Publication Date: 13-Aug-2015
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 15-Jun-2015
• Due Date: 20-Aug-2015
• Completion Date: 14-Aug-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN 60601-2-54:2009/A1:2015 - Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

Relations

• Replaced By: SIST EN IEC 60601-2-54:2024 - Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (IEC 60601-2-54:2022)
• Effective Date: 01-Nov-2024
• Amends: SIST EN 60601-2-54:2009 - Medical electrical equipment - Part 2-54: Particular requirements for basic safety and essential performance of X-ray equipment for radiography and radioscopy (IEC 60601-2-54:2009)
• Effective Date: 07-Jun-2022

Overview

SIST EN 60601-2-54:2009/A1:2015 is a European Standard issued by CLC that specifies particular requirements for the basic safety and essential performance of X-ray equipment used in radiography and radioscopy. This amendment A1 updates the original 2009 edition by incorporating references to the first amendment to IEC 60601-1:2005 and resolving several technical errors to enhance compliance, safety, and performance of medical electrical X-ray devices.

This standard is part of the IEC 60601 series, focusing on medical electrical equipment and ensuring that such devices meet harmonized requirements for safety and performance. It particularly serves manufacturers, engineers, healthcare providers, and regulatory bodies involved with diagnostic X-ray equipment, ensuring devices operate safely and effectively while protecting both patients and operators.

Key Topics

• Basic Safety and Essential Performance
  The standard outlines minimum safety and performance criteria specific to X-ray machines designed for radiographic and radioscopic procedures. It aligns with the general requirements defined in IEC 60601-1:2005 and its amendments.

• Focused Amendment Updates
  This 2015 amendment includes:

  • Updated normative references, especially IEC 60601-1:2005/AMD1:2012
  • Removal of dated references such as IEC 60601-1-2:2007 related to electromagnetic compatibility (EMC) replaced by undated references
  • Enhanced definitions and terms aligning with the latest amendments to the general standard
  • Clarification on essential and potential essential performance requirements
  • Modifications concerning mechanical hazard protections, including guarding and usability engineering for moving parts
  • Improved radiation protection protocols including dose management, filtration requirements, and dosimetric indications
  • Strengthened requirements for marking, documentation, and instructions for use related to X-ray emission

• Risk Management and Usability
  Compliance and testing emphasize the manufacturer’s risk management process, focusing on minimizing EMC interference, preventing unintended movements, and ensuring safe operation via usability engineering.

• Radiation Safety
  Inclusion of measures for radiation protection, such as half-value layer determination, filtration standards, and continuous dosage displays, aims to mitigate hazards to patients and operators.

Applications

This standard is essential for the development, manufacture, and maintenance of medical X-ray equipment used in:

• Radiography – Imaging of body structures by X-rays for diagnostic purposes
• Radioscopy (Fluoroscopy) – Real-time X-ray imaging to observe internal structures dynamically

Typical users and stakeholders who benefit from compliance with SIST EN 60601-2-54:2009/A1:2015 include:

• Medical device manufacturers ensuring product safety, performance, and regulatory compliance
• Healthcare practitioners and radiologic technologists handling X-ray machines under standardized safety protocols
• Medical device regulators and certification bodies applying consistent evaluation benchmarks
• Biomedical engineers and maintenance teams focusing on serviceability and equipment risk mitigation

By aligning with this amendment, devices better conform to EU directives like 93/42/EEC on medical devices, promoting patient safety and facilitating market access across Europe.

Related Standards

SIST EN 60601-2-54:2009/A1:2015 references and harmonizes with several other critical standards for medical electrical equipment, including but not limited to:

• IEC 60601-1:2005 and Amendments – General requirements for basic safety and essential performance of medical electrical equipment
• IEC 60601-1-3:2008 (+AMD1:2013) – Radiation protection in diagnostic X-ray equipment
• IEC 60601-1-8, -1-10, -1-11, -1-12 – Collateral standards for particular application environments (home healthcare, emergency medical services) though not directly applied here
• IEC 60601-2-43 – Safety requirements for X-ray equipment related to mammography
• IEC 60627 – Particular requirements for X-ray tube assemblies

These standards collectively ensure comprehensive safety, performance, and electromagnetic compatibility (EMC) considerations essential in medical imaging technology.

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Keywords: EN 60601-2-54 amendment, X-ray equipment safety, radiography standards, radioscopy performance, medical electrical equipment, IEC 60601 series, medical device compliance, radiation protection, diagnostic imaging standards, ME equipment risk management

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2015
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Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and
essential performance of X-ray equipment for radiography and radioscopy
Medizinische elektrische Geräte - Teil 2-54: Besondere Festlegungen für die Sicherheit
und die wesentlichen Leistungsmerkmale von Röntgeneinrichtungen für Radiographie
und Radioskopie
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
Ta slovenski standard je istoveten z: EN 60601-2-54:2009/A1:2015
ICS:
11.040.50 Radiografska oprema Radiographic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60601-2-54:2009/A1

NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2015
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/A1:2015)
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/A1:2015) (IEC 60601-2-54:2009/A1:2015)
This amendment A1 modifies the European Standard EN 60601-2-54:2009; it was approved by CENELEC on 2015-05-22. 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, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-54:2009/A1:2015 E

Foreword
The text of document 62B/929/CDV, future IEC 60601-2-54:2009/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 60601-2-54:2009/A1:2015.
The following dates are fixed:
(dop) 2016-02-22
• latest date by which the document has to be implemented at
national level by publication of an identical national
standard or by endorsement
(dow) 2018-05-22
• 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.
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 93/42/EEC, see informative Annex ZZ, included in
EN 60601-2-54:2009.
Endorsement notice
The text of the International Standard IEC 60601-2-54:2009/A1:2015 was approved by CENELEC as
a European Standard without any modification.
In the Bibliography of EN 60601-2-54:2009, replace notes [1] and [15] by the following notes:
[1] IEC 60627 NOTE Harmonized as EN 60627.
[15] IEC 60601-2-43 NOTE Harmonized as EN 60601-2-43.

In the Bibliography of EN 60601-2-54:2009, the following notes have to be added for the standards indicated:
[16] IEC 60601-1-11 NOTE Harmonized as EN 60601-1-11.
[17] IEC 60601-1-12 NOTE Harmonized as EN 60601-1-12.

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.

Publication Year Title EN/HD Year
In Annex ZA of EN 60601-2-54:2009, add the following new reference:
IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic
- -  + corrigendum Mar. 2010
safety and essential performance
+ A1 2012 + A1 2013
- -  + A1/AC 2014
- -  + A12 2014
In Annex ZA of EN 60601-2-54:2009, delete IEC 60601-1-2:2007:
IEC 60601-1-2 2007 Medical electrical equipment - EN 60601-1-2 2007
(mod) Part 1-2: General requirements for basic
safety and essential performance -
Collateral Standard: Electromagnetic
compatibility - Requirements and tests
In Annex ZA of EN 60601-2-54:2009, replace IEC 60601-1-3 by the following:
IEC 60601-1-3 2008 Medical electrical equipment - EN 60601-1-3 2008
Part 1-3: General requirements for basic
- -  + corrigendum Mar. 2010
safety and essential performance -
+ A1 2013 + A1 2013
Collateral Standard: Radiation protection in
- -  + A1/AC 2014
diagnostic X-ray equipment
IEC 60601-2-54 ®
Edition 1.0 2015-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
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 978-2-8322-2567-7

– 2 – IEC 60601-2-54:2009/AMD1:2015
© IEC 2015
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/929/CDV 62B/956/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.
_____________
IEC 60601-2-54:2009/AMD1:2015 – 3 –
© IEC 2015
INTRODUCTION TO AMENDMENT 1
The purpose of this first amendment to IEC 60601-2-54:2009 is to introduce changes to
reference the first amendment (2012) to IEC 60601-1:2005. As neither IEC 60601-2-54:2009
nor this amendment refers to specific elements of
...