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Abstract

Status: Replaced
Publication Date: 14-Jun-2016

ICS: 11.040.50 - Radiographic equipment

Technical Committee: SC 62C - Equipment for radiotherapy, nuclear medicine and radiation dosimetry

Current Stage: DELPUB - Deleted Publication
Start Date: 14-Jan-2026
Completion Date: 28-Aug-2026

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IEC 61303:1994/COR1:2016 - Corrigendum 1 - Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance
Released:6/15/2016 - Page 1 preview

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IEC 61303:1994/COR1:2016 - Corrigendum 1 - Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance Released:6/15/2016

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IEC 61303:1994/COR1:2016 - Corrigendum 1 - Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance Released:6/15/2016

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Frequently Asked Questions

What is IEC 61303:1994/COR1:2016?

IEC 61303:1994/COR1:2016 is a standard published by the International Electrotechnical Commission (IEC). Its full title is "Corrigendum 1 - Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance". This standard covers: Corrigendum 1 - Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance

What is the scope of IEC 61303:1994/COR1:2016?

Corrigendum 1 - Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance

What ICS categories does IEC 61303:1994/COR1:2016 belong to?

IEC 61303:1994/COR1:2016 is classified under the following ICS (International Classification for Standards) categories: 11.040.50 - Radiographic equipment. The ICS classification helps identify the subject area and facilitates finding related standards.

How can I access IEC 61303:1994/COR1:2016?

IEC 61303:1994/COR1:2016 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)

IEC 61303:1994/COR1:2016 - Cor...

 IEC 2016
INTERNATIONAL ELECTROTECHNICAL COMMISSION
COMMISSION ÉLECTROTECHNIQUE INTERNATIONALE
____________
IEC 61303 IEC 61303
Edition 1.0 1994-09 Édition 1.0 1994-09

Medical electrical equipment – Appareils électromédicaux –

Radionuclide calibrators – Calibrateurs de radionucléides –

Particular methods for describing performance Méthodes particulières pour décrire
les performances
CO RRI G ENDU M 1
4.1.2.2 Evaluation 4.1.2.2 Évaluation
Replace the third sentence of the Remplacer la troisième phrase de ce
subclause by the following new sentence: paragraphe par la nouvelle phrase
suivante:
...

IEC

IEC 61267:2025(Main)

Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics

IEC 61267:2025 applies to test procedures which, for the determination of characteristics of systems or components of medical diagnostic X-ray equipment, require well-defined X-ray radiation conditions. This document deals with methods for generating X-ray radiation conditions which can be used under test conditions typically found in test laboratories or in manufacturing facilities for the determination of characteristics of medical diagnostic X-ray equipment.
IEC 61267:2025 cancels and replaces the second edition published 2005. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
a) removing former Annex C “Measurement of the practical peak voltage”;
b) inserting informative “Tabulated values for the squared signal-to-noise ratio per air kerma (SNR2in)” and normative “Additional X-ray radiation conditions as used in mammography and determination of the corresponding nominal aluminium half-value layers”;
c) revision of X-ray radiation conditions;
d) new method for verification of X-ray radiation conditions;
e) change of term definitions.

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30-Mar-2026
11.040.50
SC 62C

IEC

IEC 63465:2026(Main)

Calibration and quality control in the use of radionuclide calibrators

IEC 63465:2026 specifies the techniques for calibration and usage of pressurised, well-type ionisation chambers for activity measurements of radioactive sources. Such instruments are used to determine the activity, expressed in becquerel (Bq), of photon and some medium to high-energy beta-emitters.
This document addresses calibration procedures of ionisation chambers and radionuclide calibrators to be used by equipment manufacturers, national metrology institutes and designated institutes, radionuclide producers, suppliers, distributors, and end users, like nuclear medicine facilities, industrial or hospital (radio)pharmacies, research laboratories, and nuclear power plants.
This document provides the methods and tests for establishing conformity of device acceptability and maintaining acceptable instrument performance. Performance benchmarks vary depending on the application, so information is given specific to field class instruments for end users and reference class instruments for standards laboratories and instrument manufacturers.
The ionisation chamber or radionuclide calibrator can be an instrument that is used as a standalone device, but it can also be integrated in a much larger appliance, such as a laminar air flow cabinet, a fume hood, a hot cell, or a dispensing unit. The instrument can also be equipped with accessories that are essential for the intended use of the appliance that surrounds and incorporates the radionuclide calibrator. The proper use of each of the accessories can be important for the correct use of the radionuclide calibrator and therefore is part of the scope of this document.
The software and computer system(s) that can be used to control the radionuclide calibrator hardware and functioning are considered an integral part of the device and therefore are also considered part of the scope of this document.
IEC 63465:2026 cancels and replaces IEC TR 61948-4:2019, IEC 61303:1994, IEC 61145:1992. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to IEC TR 61948-4:2019, IEC 61303:1994 and IEC 61145:1992:
a) technical specifications and quality control procedures are updated to apply to modern instruments;
b) test acceptance criteria are defined for reference class and field class devices;
c) recommendations are given on recording and logging of test data, including the use of control charts;
d) specific calibration guidance is included, including guidance for subsidiary calibrations with end-user-defined source geometries.

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13-Jan-2026
11.040.50
SC 62C

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IEC 63322:2025(Main)

Security of ME equipment containing high-activity sealed radioactive sources

IEC 63322:2025 establishes security requirements of ME EQUIPMENT using high-activity SEALED RADIOACTIVE SOURCES, directly or indirectly, for medical treatment and other clinical procedures. ME EQUIPMENT containing SEALED RADIOACTIVE SOURCES that are defined as Category 1, 2 and 3 RADIOACTIVE SOURCES by IAEA are subject to this document. The object of this document is to specify requirements for the security of ME EQUIPMENT containing high-activity SEALED RADIOACTIVE SOURCES with the aim to minimize the risk of unauthorized access to the contained SEALED RADIOACTIVE SOURCES, and to serve as the basis for other standards. This document contains requirements for the MANUFACTURER of the ME EQUIPMENT and, separately, for the RESPONSIBLE ORGANIZATION regarding security at the location during use and storage. The requirements of this document apply when the SEALED RADIOACTIVE SOURCES are contained in the ME EQUIPMENT, i.e. from the time when the SEALED RADIOACTIVE SOURCES are inserted into the ME EQUIPMENT, during the INTENDED USE and when the ME EQUIPMENT is not being used for its INTENDED USE or taken out of regular use, until the equipment is being decommissioned, i.e. until all SEALED RADIOACTIVE SOURCES are permanently removed from the equipment.

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27-Jul-2025
11.040.50
SC 62C

IEC

IEC 61674:2024(Main)

Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging

IEC 61674:2024 specifies the performance and some related constructional requirements of DIAGNOSTIC DOSIMETERS intended for the measurement of AIR KERMA, AIR KERMA LENGTH PRODUCT or AIR KERMA RATE, in photon radiation fields used in medical X-ray imaging, such as RADIOGRAPHY, RADIOSCOPY and COMPUTED TOMOGRAPHY (CT), for X-RADIATION with generating potentials in the range of 20 kV to 150 kV. This document is applicable to the performance of DOSIMETERS with VENTED IONIZATION CHAMBERS and/or SEMICONDUCTOR DETECTORS as used in X-ray diagnostic imaging.
IEC 61674:2024 cancels and replaces the second edition published in 2012. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) for mammography, the manufacturer specifies the REFERENCE VALUE for the RADIATION QUALITY;
b) for mammography, the manufacturer provides the MINIMUM RATED RANGE of RADIATION QUALITIES for the compliance test on energy dependence of response;
c) the compliance test for analogue displays was removed;
d) the compliance tests for range reset, the effect of leakage and recombination losses were removed. These tests are already covered by the test on linearity and cannot be conducted for modern devices. The estimation of COMBINED STANDARD UNCERTAINTY was changed accordingly;
e) the compliance test for mains rechargeable and battery-operated dosimeters were updated for modern devices

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08-Jul-2024
11.040.50
SC 62C

IEC

IEC 61676:2023/COR1:2024(Corrigendum)

Corrigendum 1 - Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology

Standard
1 page
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IEC

IEC 61676:2023(Main)

Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology

IEC 61676:2023 specifies the performance requirements of instruments as used in the non-invasive measurement of X-RAY tube voltage up to 150 kV and the relevant compliance tests. This document also describes the method for calibration and gives guidance for estimating the uncertainty in measurements performed under conditions different from those during calibration. Applications for such measurement are found in diagnostic radiology including mammography, computed tomography (CT), dental radiology and radioscopy. This document is not concerned with the safety aspect of such instruments. The requirements for electrical safety applying to them are contained in IEC 61010-1. IEC 61676:2023 cancels and replaces first edition published in 2002, Amendment 1:2008. This edition constitutes a technical revision. It includes an assessment of the combined standard uncertainty for the performance of a hypothetical instrument for the non-invasive measurement of the tube high voltage (in Annex A) which replaces Annex A of the edition 1.1 titled "Recommended performance criteria for the invasive divider".
The contents of the corrigendum of January 2024 have been included in this copy.

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IEC 61675-1:2022(Main)

Radionuclide imaging devices - Characteristics and test conditions - Part 1: Positron emission tomographs

IEC 61675-1:2022 specifies terminology and test methods for declaring the characteristics of POSITRON EMISSION TOMOGRAPHS. POSITRON EMISSION TOMOGRAPHS detect the ANNIHILATION RADIATION of positron emitting RADIONUCLIDES by COINCIDENCE DETECTION. IEC 61675-1:2022 cancels and replaces the second edition published in 2013. This edition constitutes a technical revision. This edition includes the following significant technical change with respect to the previous edition: requirements have been changed or newly created regarding the technical aspects of SPATIAL RESOLUTION, sensitivity measurement, SCATTER FRACTION, COUNT RATE performance, image quality, PET/CT registration accuracy and time-of-flight resolution.

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87 pages
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17-Mar-2022
11.040.50
SC 62C

IEC

IEC 63073-1:2020(Main)

Dedicated radionuclide imaging devices - Characteristics and test conditions - Part 1: Cardiac SPECT

IEC 63073-1:2020 specifies terminology and test methods for describing the characteristics of SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT) systems designed specifically for tomographic cardiac imaging. This includes dedicated systems or general purpose systems with dedicated sub-systems which are not included in the scope of IEC 61675-2.

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58 pages
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26-Oct-2020
11.040.50
SC 62C

IEC

IEC 60580:2019(Main)

Medical electrical equipment - Dose area product meters

IEC 60580:2019 specifies the performance and testing of Dose Area Product Meters intended to measure Dose Area Product and/or Dose Area Product Rate to which the Patient is exposed during Medical Radiological Examinations. This document is applicable to the following types of Dose Area Product Meters:
a) Field-Class Dose Area Product Meters normally used for the measurement of Dose Area Products during Medical Radiological Examinations;
b) Reference-Class Dose Area Product Meters normally used for the Calibration of Field-Class Dosimeters.
NOTE Reference-Class Dose Area Product Meters can be used as Field-Class Dose Area Product Meters.
The object of this document is
1) to establish requirements for a satisfactory level of performance for Dose Area Product Meters, and
2) to standardize the methods for the determination of compliance with this level of performance.
Two levels of performance are specified:
– a lower level of performance applying to Field-Class Dose Area Product Meters;
– a higher level of performance applying to Reference-Class Dose Area Product Meters.
IEC 60580:2019 cancels and replaces the second edition published 2000, and constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
a) a second class of devices is introduced with tighter uncertainty tolerances;
b) this document has been expanded to include detectors other than ionization chambers;
c) radiation qualities have been updated to the new definitions according to IEC 61267;
d) a requirement on the linearity of the dose area product rate measurement was added;
e) changed chamber light transmission requirement from 70 % to 60 %.

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107 pages
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69 pages
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11-Nov-2019
11.040.50
SC 62C

IEC

IEC TR 61948-2:2019(Main)

Nuclear medicine instrumentation - Routine tests - Part 2: Scintillation cameras and single photon emission computed tomography imaging

IEC TR 61948-2:2019 is valid for single photon scintillation cameras with parallel hole collimators used in planar scintigraphy and tomography. It is also valid for the SPECT portion of SPECT/CT systems with parallel hole collimators, including the co-registration between the SPECT and CT subsystems. The objective is to specify ROUTINE TESTS for QUALITY CONTROL. Methods for the ACCEPTANCE TEST are described in IEC 61675-2.
IEC TR 61948-2:2019 cancels and replaces the first edition published in 2001. It constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) adaptation to apply to the present technology;
b) updating of the test methods to comply with the recent state of the art.

Technical report
15 pages
English language
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20-Aug-2019
11.040.50
SC 62C

General Information

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IEC 61303:1994/COR1:2016 - Corrigendum 1 - Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance Released:6/15/2016

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IEC 61303:1994/COR1:2016 - Corrigendum 1 - Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance Released:6/15/2016

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