SIST EN 60731:2012/A1:2022

Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy (IEC 60731:2011/A1:2016)

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Medizinische elektrische Geräte - Dosimeter mit Ionisationskammern zur Anwendung in der Strahlentherapie (IEC 60731:2011/A1:2016)

Appareils électromédicaux - Dosimètres à chambres d'ionisation utilisés en radiothérapie (IEC 60731:2011/A1:2016)

Medicinska električna oprema - Dozimetri z ionizacijskimi komorami, ki se uporabljajo v radioterapiji - Dopolnilo A1 (IEC 60731:2011/A1:2016)

Amandma A1:2022 je dodatek k standardu SIST EN 60731:2012.
Ta mednarodni standard določa zahteve glede zmogljivosti DOZIMETROV ZA RADIOTERAPIJO, namenjenih za merjenje ABSORBIRANEGA ODMERKA NA VODO ali KERME V ZRAKU (in njihovih stopenj ter prostorskih razporeditev) na FOTONSKIH, ELEKTRONSKIH, protonskih ali težko ionskih POLJIH SEVANJA za uporabo v RADIOTERAPIJI. SISTEMI NADZIRANJA ODMERKOV v napravah za zdravljenje z RADIOTERAPIJO in povratne IONIZACIJSKE KOMORE, ki se uporabljajo za kalibracijo virov in preverjanje stalnosti v BRAHITERAPIJI, niso zajeti v tem standardu. Ta standard se uporablja za naslednje vrste dozimetrov: a) PODROČNI DOZIMETRI se običajno uporabljajo za: 1) merjenje KERME ali odmerka v RADIOLOŠKEM ŽARKU v zraku ali na FANTOMU, 2) in vivo meritve odmerka na površini kože ali v notranjih organih pri PACIENTIH; b) REFERENČNI DOZIMETRI se običajno uporabljajo za kalibracijo PODROČNIH DOZIMETROV; OPOMBA: REFERENČNI DOZIMETRI se lahko uporabljajo kot PODROČNI DOZIMETRI; c) SKENIRNI DOZIMETRI se običajno uporabljajo za meritve relativne distribucije odmerka s SISTEMOM SKENIRANJA, kot je avtomatski vodni FANTOM.

General Information

• Status: Published
• Publication Date: 04-Sep-2022
• ICS: 11.040.50 - Radiographic equipment
• ICS: 17.240 - Radiation measurements
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 23-Aug-2022
• Due Date: 28-Oct-2022
• Completion Date: 05-Sep-2022
• 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 60731:2012/A1:2022 - Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy

Relations

• Amends: SIST EN 60731:2012 - Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
• Effective Date: 03-Sep-2014

Overview

EN 60731:2012/A1:2022 is the CENELEC adoption of IEC 60731:2011/A1:2016 and amends the original EN 60731:2012 for medical electrical equipment - specifically dosimeters with ionization chambers used in radiotherapy. The amendment clarifies performance characteristics, modifies test procedures and updates classifications such as the SCANNING-CLASS dosimeter. Key administrative dates include national implementation by 2023-02-12 and withdrawal of conflicting national standards by 2025-08-12.

Key Topics

• Scope and basis: Amendment A1 endorses the international IEC text without modification and applies across CENELEC member countries.
• Performance characteristics: The amendment updates summary tables and footnotes for limits of performance at standard test conditions for the measuring assembly.
• Zero drift: New text defines ZERO DRIFT limits in relation to the rate of change of the indicated value produced by the minimum rated input current. Specified limits appear as ±1.0% (±0.5%) in the amendment where shown.
• Scanning-class classification: A RADIOTHERAPY DOSIMETER may be classified as SCANNING-CLASS if it meets FIELD-CLASS performance requirements with defined modifications.
• Test procedure changes: The amendment revises test steps (notably items j, k, l) that validate behavior during interrupted input signals-relevant for step-and-shoot IMRT beams. The test sequence requires repeated measurements with interruption intervals x = 2, 3, 5, 10, 30, 60 seconds and calculation of charge differences ∆Q and derived values D or I expressed as percentages of minimum rated input.

Applications

This standard is intended for manufacturers, test labs, clinical physicists and regulators involved with radiotherapy dose measurement. Practical applications include:

• Selection and classification of dosimeters for external beam radiotherapy and scanning systems.
• Type testing and acceptance testing of ionization-chamber dosimeters to verify zero-drift, response linearity and stability under clinical-like interruptions (e.g., IMRT step-and-shoot delivery).
• Supporting conformity assessment and national transposition across CENELEC members for clinical device deployment and quality assurance programs.

Related Standards

• IEC 60731:2011/A1:2016 (base international publication that this amendment adopts)
• Broader IEC/TC 62 standards covering medical electrical equipment and radiation dosimetry

Practical value: EN 60731:2012/A1:2022 provides clear test requirements and performance limits that improve measurement reliability and comparability of dosimeters used in radiotherapy, helping clinicians and manufacturers meet recognized European and international benchmarks.

For implementation details, test setups, and exact table values refer to the full published amendment text and national committee guidance.

Standards Content (Sample)

SLOVENSKI STANDARD
01-oktober-2022
Medicinska električna oprema - Dozimetri z ionizacijskimi komorami, ki se
uporabljajo v radioterapiji - Dopolnilo A1 (IEC 60731:2011/A1:2016)
Medical electrical equipment - Dosimeters with ionization chambers as used in
radiotherapy (IEC 60731:2011/A1:2016)
Medizinische elektrische Geräte - Dosimeter mit Ionisationskammern zur Anwendung in
der Strahlentherapie (IEC 60731:2011/A1:2016)
Appareils électromédicaux - Dosimètres à chambres d'ionisation utilisés en radiothérapie
(IEC 60731:2011/A1:2016)
Ta slovenski standard je istoveten z: EN 60731:2012/A1:2022
ICS:
11.040.50 Radiografska oprema Radiographic equipment
17.240 Merjenje sevanja Radiation measurements
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60731:2012/A1

NORME EUROPÉENNE
EUROPÄISCHE NORM August 2022
ICS 11.040.50
English Version
Medical electrical equipment - Dosimeters with ionization
chambers as used in radiotherapy
(IEC 60731:2011/A1:2016)
Appareils électromédicaux - Dosimètres à chambres Medizinische elektrische Geräte - Dosimeter mit
d'ionisation utilisés en radiothérapie Ionisationskammern zur Anwendung in der Strahlentherapie
(IEC 60731:2011/A1:2016) (IEC 60731:2011/A1:2016)
This amendment A1 modifies the European Standard EN 60731:2012; it was approved by CENELEC on 2016-05-13. 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,
Türkiye 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
© 2022 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60731:2012/A1:2022 E

European foreword
The text of document 62C/596/CDV, future IEC 60731/A1, prepared by SC 62C "Equipment for
radiotherapy, nuclear medicine and radiation dosimetry" of IEC/TC 62 "Electrical equipment in medical
practice" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2023-02-12
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2025-08-12
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.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 60731:2011/A1:2016 was approved by CENELEC as a
European Standard without any modification.

IEC 60731 ®
Edition 3.0 2016-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AM ENDMENT 1
AM ENDEMENT
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