SIST EN 60601-2-44:2009/A2:2016

Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography

IEC 60601-2-44:2009 applies to the basic safety and essential performance of CT scanners. The scope of IEC 60601-2-44:2009 is limited to CT scanners intended to be used for both head and body characterised by an enclosure of the X-ray source(s) and imaging detector(s) in a common protective cover in the shape of a toroid. It includes safety requirements for the X-ray generators used in CT scanners, including those where high-voltage generators are integrated with an X-ray tube assembly. This third edition cancels and replaces the second edition published in 2001 and its Amendment 1 (2002). This edition constitutes a technical revision primarily related to radiation protection and control.

Medizinische elektrische Geräte - Teil 2-44: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Röntgeneinrichtungen für die Computertomographie

Appareils électromédicaux - Partie 2-44: Exigences particulières pour la sécurité de base et les performances essentielles des équipements à rayonnement X de tomodensitométrie

Medicinska električna oprema - 2-44. del: Posebne zahteve za osnovno varnost in bistvene lastnosti rentgenske opreme za računalniško tomografijo - Dopolnilo A2

General Information

• Status: Published
• Publication Date: 19-Jun-2016
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 14-Jun-2016
• Due Date: 19-Aug-2016
• Completion Date: 20-Jun-2016
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: EN 60601-2-44:2009/A2:2016 - Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography

Relations

• Revised: oSIST prEN IEC 60601-2-44:2026 - Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
• Effective Date: 18-Feb-2025

Overview

SIST EN 60601-2-44:2009/A2:2016 is a European standard aligned with the international IEC 60601-2-44:2009/A2:2016, issued by the European Committee for Electrotechnical Standardization (CENELEC). This standard specifies the particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography (CT) scanners. It focuses on CT scanners designed for both head and body examinations, featuring an enclosure where the X-ray source(s) and imaging detector(s) are housed within a common protective toroidal cover. This third edition includes key technical revisions with emphasis on radiation protection and control.

The standard replaces the second edition from 2001 and its first amendment, providing updated normative references to general and collateral medical electrical equipment standards to ensure consistency with evolving technology and safety practices.

Key Topics

• Scope and Application
  Applies specifically to CT scanners intended for head and body imaging, integrating X-ray sources and detectors in a protected enclosure, and addresses safety aspects of high-voltage X-ray generators.

• Radiation Protection and Control
  Emphasizes enhanced safety protocols for radiation exposure, including updated measurement and evaluation methods like CT Dose Index (CTDI) for dose assessment.

• Risk Management and Alternative Measures
  Supports the use of risk management to approve alternative risk control methods when strict compliance is technologically unfeasible, provided residual risks remain equal or lower.

• Electromagnetic Compatibility (EMC)
  Aligns with IEC 60601-1-2:2014 to ensure CT equipment maintains performance and safety in electromagnetic environments.

• Programmable Electrical Medical Systems (PEMS)
  Specifies requirements related to software and programmable components critical to basic safety and essential performance, reflecting updated general standards.

• Normative References
  Incorporates recent amendments to IEC 60601-1 series standards for general safety, EMC, and radiation protection, ensuring harmonized regulatory compliance.

Applications

• Medical Imaging Facilities
  Hospitals and diagnostic centers using CT scanners rely on this standard to verify that scanners meet stringent safety and performance criteria, specifically safeguarding patients and operators from excessive radiation exposure.

• Medical Device Manufacturers
  Producers of CT equipment apply this standard during design, development, and testing phases to ensure compliance with European and international safety mandates before market entry.

• Regulatory Bodies
  Certification agencies use SIST EN 60601-2-44:2009/A2:2016 to evaluate device safety documentation and performance validation to ensure equipment suitability for clinical deployment.

• Quality Assurance Programs
  Medical physicists and technical teams implement tests and controls based on this standard to maintain device functionality and safety over the operational lifecycle.

Related Standards

• IEC 60601-1:2005 and Amendments (General Requirements)
  Defines overarching safety principles for medical electrical equipment, serving as a foundational reference for particular standards like 60601-2-44.

• IEC 60601-1-2:2014 (Electromagnetic Disturbances)
  Details EMC requirements and test methods for medical electrical devices, ensuring immunity from and control of electromagnetic interference.

• IEC 60601-1-3:2008/AMD1:2013 (Radiation Protection in Diagnostic Equipment)
  Provides collateral specifications specifically aimed at radiation safety in diagnostic X-ray systems, complementing the CT scanner-specific requirements.

• IAEA Human Health Reports No. 5 (2011)
  Offers practical guidance on computed tomography dosimetry, including dose measurement techniques relevant to compliance verification for CT scanners.

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Keywords: EN 60601-2-44, IEC 60601-2-44, CT scanner safety, computed tomography standards, medical electrical equipment, radiation protection, electromagnetic compatibility, programmable medical systems, CT dose measurement, CENELEC medical standards, medical device compliance

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2016
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Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and
essential performance of X-ray equipment for computed tomography
Appareils électromédicaux - Partie 2-44: Exigences particulières pour la sécurité de base
et les performances essentielles des équipements à rayonnement X de
tomodensitométrie
Ta slovenski standard je istoveten z: EN 60601-2-44:2009/A2:2016
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 60601-2-44:2009/A2

NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2016
ICS 11.040.50
English Version
Medical electrical equipment - Part 2-44: Particular requirements
for the basic safety and essential performance of X-ray
equipment for computed tomography
(IEC 60601-2-44:2009/A2:2016)
Appareils electromédicaux - Partie 2-44: Exigences Medizinische elektrische Geräte - Teil 2-44: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des équipements à rayonnement X de wesentlichen Leistungsmerkmale von
tomodensitométrie Röntgeneinrichtungen für die Computertomographie
(IEC 60601-2-44:2009/A2:2016) (IEC 60601-2-44:2009/A2:2016)
This amendment A2 modifies the European Standard EN 60601-2-44:2009; it was approved by CENELEC on 2016-05-05. 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
© 2016 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-44:2009/A2:2016 E

European foreword
The text of document 62B/976/CDV, future IEC 60601-2-44:2009/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 60601-2-44:2009/A2:2016.
The following dates are fixed:
(dop) 2017-02-05
• latest date by which the document has to be implemented at
national level by publication of an identical national
standard or by endorsement
(dow) 2019-05-05
• 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(s), see informative Annex ZZ, included in EN 60601-2-44:2009.
Endorsement notice
The text of the International Standard IEC 60601-2-44:2009/A2:2016 was approved by CENELEC as
a European Standard without any modification.
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 60601-2-44:2009, replace the existing references to the following publications as
follows:
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
- -  + A12 2014
IEC 60601-1-2 2014 Medical electrical equipment - EN 60601-1-2 2015
Part 1-2: General r
...