SIST EN 60601-2-44:2002/A1:2003

Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography (IEC 60601-2-44:2001/A1:2002)

Superseded by EN 60601-2-44:2009

Medizinische elektrische Geräte - Teil 2-44: Besondere Festlegungen für die Sicherheit von Röntgeneinrichtungen für die Computer-Tomographie (IEC 60601-2-44:2001/A1:2002)

Appareils électromédicaux - Partie 2-44: Règles particulières de sécurité pour les équipements à rayonnement X de tomodensitométrie (CEI 60601-2-44:2001/A1:2002)

Medicinska električna oprema - 2-44. del: Posebne varnostne zahteve za rentgensko opremo za računalniško podprto tomografijo (IEC 60601-2-44:2001/A1:2002)

General Information

• Status: Withdrawn
• Publication Date: 31-Mar-2003
• Withdrawal Date: 06-Jun-2012
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 07-Jun-2012
• Due Date: 30-Jun-2012
• Completion Date: 07-Jun-2012
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN 60601-2-44:2001/A1:2003 - Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography

Relations

• Amends: SIST EN 60601-2-44:2002 - Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography (IEC 60601-2-44:2001)
• Effective Date: 01-Apr-2003
• Replaced By: SIST EN 60601-2-44:2009 - Medical electrical equipment - Part 2-44: Particular requirements for basic safety and essential performance of X-ray equipment for computed tomography (IEC 60601-2-44:2009)
• Effective Date: 29-Jan-2023
• Replaced By: SIST EN 60601-2-44:2009 - Medical electrical equipment - Part 2-44: Particular requirements for basic safety and essential performance of X-ray equipment for computed tomography (IEC 60601-2-44:2009)
• Effective Date: 07-Jun-2022
• Amends: SIST EN 60601-2-44:2002 - Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography (IEC 60601-2-44:2001)
• Effective Date: 29-Jan-2023
• Amends: SIST EN 60601-2-44:2002 - Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography (IEC 60601-2-44:2001)
• Effective Date: 07-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-44:2002/A1:2003
01-april-2003
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQHYDUQRVWQH]DKWHYH]D
UHQWJHQVNRRSUHPR]DUDþXQDOQLãNRSRGSUWRWRPRJUDILMR,(&
$
Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray
equipment for computed tomography (IEC 60601-2-44:2001/A1:2002)
0HGL]LQLVFKHHOHNWULVFKH*HUlWH7HLO%HVRQGHUH)HVWOHJXQJHQIUGLH6LFKHUKHLW
YRQ5|QWJHQHLQULFKWXQJHQIUGLH&RPSXWHU7RPRJUDSKLH
,(&$
Appareils électromédicaux - Partie 2-44: Règles particulières de sécurité pour les
équipements à rayonnement X de tomodensitométrie (CEI 60601-2-44:2001/A1:2002)
Ta slovenski standard je istoveten z: EN 60601-2-44:2001/A1:2003
ICS:
11.040.50 Radiografska oprema Radiographic equipment
SIST EN 60601-2-44:2002/A1:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD EN 60601-2-44/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM January 2003

ICS 11.040.50


English version


Medical electrical equipment
Part 2-44: Particular requirements for the safety
of X-ray equipment for computed tomography
(IEC 60601-2-44:2001/A1:2002)


Appareils électromédicaux Medizinische elektrische Geräte
Partie 2-44: Règles particulières Teil 2-44: Besondere Festlegungen für
de sécurité pour les équipements die Sicherheit von Röntgeneinrichtungen
à rayonnement X de tomodensitométrie für die Computer-Tomographie
(CEI 60601-2-44:2001/A1:2002) (IEC 60601-2-44:2001/A1:2002)





This amendment A1 modifies the European Standard EN 60601-2-44:2001; it was approved by CENELEC
on 2002-12-01. 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 Central Secretariat 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
Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Czech Republic,
Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta,
Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels


© 2003 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.

Ref. No. EN 60601-2-44:2001/A1:2003 E

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EN 60601-2-44:2001/A1:2003 - 2 -
Foreword
The text of document 62B/472/FDIS, future amendment 1 to IEC 60601-2-44:2001, 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 was approved by CENELEC as amendment A1 to
EN 60601-2-44:2001 on 2002-12-01.

The following dates were fixed:

– latest date by which the amendment has to be implemented
 at national level by publication of an identical
 national standard or by endorsement (dop) 2003-09-01

– latest date by which the national standards conflicting
 with the amendment have to be withdrawn (dow) 2005-12-01
__________
Endorsement notice
The text of amendment 1:2002 to the International Standard IEC 60601-2-44:2001 was approved by
CENELEC as an amendment to the European Standard without any modification.
__________

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INTERNATIONAL IEC
STANDARD
60601-2-44
2001
AMENDMENT 1
2002-09
Amendment 1
Medical electrical equipment –
Part 2-44:
Particular requirements for the safety of
X-ray equipment for computed tomography
Amendement 1
Appareils électromédicaux –
Partie 2-44:
Règles particulières de sécurité pour les équipements
à rayonnement X de tomodensitométrie
 IEC 2002 Droits de reproduction réservés  Copyright - all rights reserved
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: [phone] Telefax: [phone] E-mail: [e-mail]  Web: www.iec.ch
PRICE CODE
Commission Electrotechnique Internationale
G
International Electrotechnical Commission
Международная Электротехническая Комиссия
For price, see current catalogue

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– 2 – 60601-2-44 Amend. 1  IEC:2002(E)
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/472/FDIS 62B/478/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 the base publication and its amendments will
remain unchanged until 2004-06. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
The contents of the corrigendum of April 2006 have been included in this copy.
_____________

INTRODUCTION
In the second edition of this Particular Standard six definitions were changed compared with the
first edition. These changes, however, were not in line with the definitions used in international
scientific publications. This amendment to the Particular Standard mainly corrects those
definitions and adds more detailed definitions of the dose values to be displayed.
Page 8
2 Terminology and definitions
Replace the existing definitions 2.101 and 2.106 to 2.110 by the following:
2.101
CT SCANNER
X-RAY EQUIPMENT for COMPUTED TOMOGRAPHY (CT)
diagnostic X-ray system intended to generate cross-sectional images of the body by computer
reconstruction of X-ray transmission data obtained at different angles. This generic type of
device may include signal analysis and display equipment, PATIENT SUPPORT, support parts
and ACCESSORIES
NOTE Secondary imaging processing is not included in the scope of this standard.
2.106
COMPUTED TOMOGRAPHY DOSE INDEX 100 (CTDI )
100
integral of the DOSE PROFILE produced in a single axial scan along a line perpendicular to
the TOMOGRAPHIC PLANE from –50 mm to +50 mm, divided by the product of the number of
TOMOGRAPHIC SECTIONS N and the NOMINAL TOMOGRAPHIC SECTION THICKNESS T:

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60601-2-44 Amend. 1  IEC:2002(E) – 3 –
+50 mm
D (z)
=  dz
CTDI
100
∫
N × T
−50 mm
where
D(z) is the DOSE PROFILE along a line z perpendicular to the TOMOGRAPHIC PLANE, where
dose is reported as ABSORBED DOSE to air;
N is the number of TOMOGRAPHIC SECTIONS produced in a single axial scan of the X-RAY
SOURCE;
T is the NOMINAL TOMOGRAPHIC SECTION THICKNESS.
NOTE 1 The term CTDI has been introduced as a more representative value for dose than the traditional CTDI
100
1
integrated from –7T to +7T as defined by the FDA in 21 CFR 1020.33 .
NOTE 2 The dose is reported as ABSORBED DOSE to air. This is required in order to avoid present confusion, as
some MANUFACTURERS of CT SCANNERS express dose values calculated as ABSORBED DOSE to air and others as
ABSORBED DOSE to polymethyl-methacrylate (PMMA).
Although CTDI refers to ABSORBED DOSE to air, for practical purposes the evaluation of ABSORBED DOSE to
100
air within a PMMA dosimetry PHANTOM is well approximated by measurement of the AIR KERMA with an
ionization chamber in the PHANTOM.
NOTE 3 This definition assumes that the DOSE PROFILE is centred on z = 0.
...