IEC 61675-1:2022

Overview

IEC 61675-1:2022 is the third edition of the International Electrotechnical Commission standard that defines terminology and standardized test methods for declaring the performance characteristics of positron emission tomographs (PET). It replaces the 2013 edition and introduces technical revisions to better reflect modern clinical PET and PET/CT systems. The standard covers how PET systems detect annihilation radiation from positron-emitting radionuclides using coincidence detection, and it is intended primarily for manufacturers to characterize and report PET performance in accompanying documentation.

Key topics and technical requirements

IEC 61675-1:2022 focuses on practical, reproducible test methods and reporting requirements for PET performance. Major technical topics include:

• Spatial resolution - updated requirements and measurement methods to describe system resolution.
• Tomographic sensitivity - standardized sensitivity measurement procedures for PET systems.
• Scatter fraction and scatter measurement - methods to quantify and report scatter contribution.
• Count rate performance - tests to characterize system behavior at varying activity levels, including dead time and noise-equivalent count rate.
• Image quality and quantification accuracy - phantom-based assessments for lesion detectability and activity concentration accuracy.
• PET/CT registration accuracy - evaluation of alignment between PET and CT data in hybrid systems.
• Time-of-flight (TOF) resolution - new or revised procedures to specify TOF timing performance.
• Test methods and reporting - guidance on data acquisition, analysis, and the content of accompanying documents.

The standard emphasizes fully 3D acquisition modes, is optimized for PET components of PET/CT hybrid devices, and may be applied to PET components of PET/MR systems.

Practical applications

IEC 61675-1:2022 is used to:

• Produce standardized manufacturer declarations of PET performance for datasheets and accompanying documents.
• Define acceptance test protocols and performance baselines for factory testing and installation.
• Support regulatory submissions and conformity assessments by providing recognized test methods.
• Guide clinical physicists and service engineers in system performance verification and quality assurance.
• Inform procurement specifications so hospitals and imaging centers can compare PET system performance objectively.

Who should use this standard

• PET system manufacturers (design, validation, documentation)
• Medical physicists and imaging QA/QC teams
• Independent test laboratories and certification bodies
• Hospital procurement and clinical engineering professionals
• Regulators and standards bodies reviewing PET device performance

Related standards

• Other parts of the IEC 61675 series (Radionuclide imaging devices - characteristics and test conditions)
• IEC and ISO/IEC directives referenced for standard development and normative references

Keywords: IEC 61675-1:2022, positron emission tomographs, PET, PET/CT, spatial resolution, sensitivity, scatter fraction, count rate performance, time-of-flight resolution, image quality, radionuclide imaging devices, test methods.