IEC 61675-1:2013

Overview

IEC 61675-1:2013 - Radionuclide imaging devices - Characteristics and test conditions - Part 1: Positron emission tomographs - specifies standardized terminology and test methods used to declare the performance characteristics of positron emission tomographs (PET). PET devices detect annihilation radiation from positron-emitting radionuclides using coincidence detection. This second edition (2013) is a technical revision of the 1998 edition and updates key measurement requirements relevant to modern PET imaging systems. Notably, the standard does not specify a test for uniformity of reconstructed images because available methods largely reflect image noise rather than system uniformity.

Key topics and technical requirements

The standard focuses on reproducible test methods and clear definitions for declaring PET system performance. Primary technical topics include:

• Terminology for radionuclide imaging devices and PET-specific measurement concepts
• Spatial resolution - updated requirements and measurement approaches for describing system resolution
• Sensitivity measurement - standardized procedures for quantifying system detection sensitivity
• Scatter fraction - methods to determine and report the proportion of detected counts due to scatter
• Count rate performance - tests to evaluate system response and dead-time effects at differing activity levels
• Image quality - performance metrics and test conditions for characterizing reconstructed images
• Explicit note: no uniformity test for reconstructed image uniformity is defined because of noise-dominant effects

Applications and who uses this standard

IEC 61675-1:2013 is intended for stakeholders who design, evaluate, certify, purchase, or clinically operate PET systems:

• PET system manufacturers - to declare device performance and validate design changes
• Medical physicists and clinical imaging departments - for acceptance testing, commissioning, and routine performance checks
• Regulatory bodies and notified bodies - to assess compliance and safety/performance claims for medical devices
• Independent test laboratories and service engineers - for standard test protocols and comparative benchmarking
• Procurement teams - to compare technical specifications and supplier declarations using consistent metrics

Related standards

• Other IEC standards for radionuclide imaging and nuclear medicine instrumentation
• Medical electrical equipment safety/performance standards (e.g., IEC 60601 series) and national regulatory guidance for medical devices

Keywords: imaging, medical device, positron emission tomography, PET, radionuclide imaging devices, IEC 61675-1, test methods, spatial resolution, sensitivity, scatter fraction, count rate performance, image quality.