SIST EN 60731:2012/A1:2022
(Amendment)Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy (IEC 60731:2011/A1:2016)
Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy (IEC 60731:2011/A1:2016)
NEXT ACTION: PUBLICATION EXPECTED BY 2019-10-31
2019-07-04 IP: BT decision D163/C033 - remove link to MDD
NEXT ACTION: TB Action by 21-22 May 2019 i.e. Next CLC TC 62 Plenary Meeting
2019-01-24: JO - In contact with CLC TC 62 secretary to know if an annex ZZ is expected or if a CIB will be launched to decouple this standard from the harmonization process.
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
- 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
- Not Harmonized93/42/EEC - Medical devices
Relations
- Effective Date
- 03-Sep-2014
- Effective Date
- 25-Jul-2023
Overview
SIST EN 60731:2012/A1:2022 is the Slovenian national standard adopting the European Standard EN 60731:2012/A1:2022. Aligned with IEC 60731:2011/A1:2016, this standard focuses on medical electrical equipment, specifically dosimeters with ionization chambers used in radiotherapy. These dosimeters are critical for the accurate measurement of radiation exposure, supporting effective and safe cancer treatments by enabling precise dosage delivery.
The standard provides key specifications, performance requirements, and tests needed for dosimeters to be safely and reliably used in medical settings. It serves as a reference for manufacturers, testing laboratories, and clinical users who depend on radiation dosimetry in radiotherapy.
Key Topics
Dosimeter Performance Characteristics
Outlines limits and performance characteristics for dosimeters under standard test conditions, ensuring they meet strict criteria for accuracy and reliability.Classification of Dosimeters
Details on the classification of dosimeters, including scanning-class and field-class, depending on use-case and performance.Zero Drift Requirements
Specifies maximum allowed zero drift for measuring assemblies, important for maintaining measurement accuracy over time and during repeated or variable input exposures.Test Procedures
Describes standardized procedures for testing dosimeter performance, particularly focusing on stability, repeatability, and response to changing input signals.Considerations for Advanced Radiotherapy Modalities
Addresses the measurement needs for newer treatment modalities, such as intensity-modulated radiation therapy (IMRT), ensuring dosimeters remain reliable under dynamic conditions.
Applications
Dosimeters with ionization chambers are indispensable in:
Radiotherapy Treatments:
Ensuring that patients receive the prescribed radiation dose, directly impacting treatment outcomes and patient safety.Quality Assurance (QA):
Used during routine equipment checks to maintain calibration and verify system integrity of radiotherapy devices.Equipment Calibration:
Reference-standard dosimeters help calibrate treatment machines, aligning clinical and legal requirements for radiation delivery.Research and Development:
Applied in the validation of new radiotherapy techniques or equipment modifications to establish accurate dose delivery.
With rising demands for precision in cancer care, compliance with SIST EN 60731:2012/A1:2022 is increasingly important for medical device manufacturers, hospital physicists, and clinical engineers involved in radiation dosimetry.
Related Standards
Organizations implementing or referencing SIST EN 60731:2012/A1:2022 often consult additional standards to ensure comprehensive compliance and integration, such as:
- IEC 60601 Series: Medical electrical equipment general requirements for safety and performance
- EN 60601-2-1: Particular specifications for medical electron accelerators
- ISO 4037: X and gamma reference radiation for calibrating dosemeters and doserate meters
- EN 62353: Medical electrical equipment - recurrent test and test after repair of ME equipment
By harmonizing national and international radiation measurement standards, SIST EN 60731:2012/A1:2022 helps organizations achieve high-quality, standardized radiotherapy treatments, advancing both patient care and equipment interoperability across healthcare facilities.
Keywords: medical electrical equipment, radiotherapy dosimeters, ionization chamber dosimeter, radiation measurement, standardization, IEC 60731, quality assurance, radiotherapy safety, equipment calibration, intensity-modulated radiation therapy (IMRT), Slovenian standard, EN 60731.
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Frequently Asked Questions
SIST EN 60731:2012/A1:2022 is a amendment published by the Slovenian Institute for Standardization (SIST). Its full title is "Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy (IEC 60731:2011/A1:2016)". This standard covers: NEXT ACTION: PUBLICATION EXPECTED BY 2019-10-31 2019-07-04 IP: BT decision D163/C033 - remove link to MDD NEXT ACTION: TB Action by 21-22 May 2019 i.e. Next CLC TC 62 Plenary Meeting 2019-01-24: JO - In contact with CLC TC 62 secretary to know if an annex ZZ is expected or if a CIB will be launched to decouple this standard from the harmonization process.
NEXT ACTION: PUBLICATION EXPECTED BY 2019-10-31 2019-07-04 IP: BT decision D163/C033 - remove link to MDD NEXT ACTION: TB Action by 21-22 May 2019 i.e. Next CLC TC 62 Plenary Meeting 2019-01-24: JO - In contact with CLC TC 62 secretary to know if an annex ZZ is expected or if a CIB will be launched to decouple this standard from the harmonization process.
SIST EN 60731:2012/A1:2022 is classified under the following ICS (International Classification for Standards) categories: 11.040.50 - Radiographic equipment; 17.240 - Radiation measurements. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN 60731:2012/A1:2022 has the following relationships with other standards: It is inter standard links to SIST EN 60731:2012, oSIST prEN IEC 60731:2026. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 60731:2012/A1:2022 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/295. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
SIST EN 60731:2012/A1:2022 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
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
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