EN 61303:1995

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

Covers radionuclide calibrators of the well type, with a gas-filled ionization chamber as used in the practice of nuclear medicine. The object of this Standard is to identify the most important characteristics of radionuclide calibrators and lay down associated test methods to enable manufacturers to declare the characteristics of their devices in a standardized way and facilitate comparisons between devices.

Medizinische elektrische Geräte - Aktivimeter - Spezielle Verfahren zur Bestimmung der Leistungsparameter

Appareils électromédicaux - Calibrateurs de radionucléides - Méthodes particulières pour décrire les performances

Concerne les calibrateurs de radionucléides à chambre d'ionisation remplie de gaz, de type puits, utilisés dans la pratique de la médecine nucléaire. L'objet de cette norme est d'identifier les caractéristiques les plus importantes des calibrateurs de radionucléides et de spécifier les méthodes de test associées pour permettre aux fabricants de décrire les caractéristiques de leurs appareils de façon normalisée pour faciliter les comparaisons entre les appareils.

Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance (IEC 1303:1994)

Zajema jaškaste radionuklidne kalibratorje z ionizacijsko komoro, napolnjeno s plinom, kot se uporabljajo v nuklearni medicini. Cilj tega standarda je prepoznati najpomembnejše značilnosti radionuklidnih kalibratorjev in določiti povezane preskusne metode, da se proizvajalcem omogočijo standardizirani način navedbe lastnosti njihovih pripomočkov in lažje primerjave med pripomočki.

General Information

• Status: Published
• Publication Date: 08-Jan-1995
• Withdrawal Date: 30-Nov-1995
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62C - IEC_SC_62C
• Parallel Committee: IEC/SC 62C - IEC_SC_62C
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 09-Jan-1995
• Completion Date: 09-Jan-1995
• Ref Project: SIST EN 61303:1995 - Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance

Relations

• Corrected By: EN 61303:1995/AC:2016-07 - Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance
• Effective Date: 25-Jan-2023

Overview

EN 61303:1995 - Medical electrical equipment: Radionuclide calibrators - Particular methods for describing performance (identical to IEC 1303:1994) defines standardized methods to describe and test the performance of well-type radionuclide calibrators that use a gas-filled ionization chamber, as used in nuclear medicine. The standard’s objective is to identify the most important performance characteristics and specify associated test methods so manufacturers can declare device characteristics consistently and users can compare products reliably.

Key topics

• Scope and device type: Applies specifically to well-type radionuclide calibrators with gas-filled ionization chambers used for activity measurements in nuclear medicine.
• Performance characteristics: Defines the principal characteristics to be reported (for example: accuracy, precision, reproducibility, linearity, energy dependence, background response, geometry or positioning effects, and dead-time behavior) - enabling consistent manufacturer declarations.
• Test methods: Specifies standardized measurement procedures and conditions for evaluating those characteristics so results are comparable between devices and laboratories.
• Measurement conditions and reporting: Requires clear description of test geometries, source types, measurement intervals and conditions under which performance data are determined.
• Uncertainty and comparability: Encourages reporting measurement uncertainty and using standardized metrics to support meaningful comparisons between calibrators.

Applications

• Manufacturers use the standard to develop test procedures and to prepare standardized performance specifications and declarations for product datasheets.
• Medical physicists and clinical engineers use it for device acceptance testing, commissioning, periodic quality assurance, and to interpret manufacturers’ performance claims.
• Hospitals and nuclear medicine departments rely on standardized performance data when procuring radionuclide calibrators to ensure compatibility with clinical measurement needs.
• Test laboratories and regulators apply the methods to verify compliance and to perform inter-laboratory comparisons.

Who benefits

• Manufacturers, clinical engineers, medical physicists, hospital procurement teams, conformity assessment bodies, and radiation safety officers seeking clear, comparable performance information for well-type radionuclide calibrators.

Related standards

• EN 61303:1995 is identical to IEC 1303:1994 (as referenced). Users should consult national or regional implementations and adjacent standards on electrical safety, metrology, and quality assurance in nuclear medicine for complementary requirements.

Keywords: radionuclide calibrators, well-type ionization chamber, nuclear medicine, performance description, test methods, calibration, EN 61303, IEC 1303, measurement uncertainty, device comparability.

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-1995
Medical electrical equipment - Radionuclide calibrators - Particular methods for
describing performance (IEC 1303:1994)
Medical electrical equipment - Radionuclide calibrators - Particular methods for
describing performance
Medizinische elektrische Geräte - Aktivimeter - Spezielle Verfahren zur Bestimmung der
Leistungsparameter
Appareils électromédicaux - Calibrateurs de radionucléides - Méthodes particulières pour
décrire les performances
Ta slovenski standard je istoveten z: EN 61303:1995
ICS:
11.040.50 Radiografska oprema Radiographic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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