Overview
IEC TR 61948-1:2016 - "Nuclear medicine instrumentation - Routine tests - Part 1: Gamma radiation counting systems" is a technical report that describes accepted test methods for instruments that count and measure the energy of photons emitted by radionuclides in vivo and in vitro when imaging is not used. Typical devices in scope include well counters and organ probes. The report explicitly excludes Geiger–Mueller counters and dose calibrators. This second edition cancels and replaces the 2001 edition and represents a technical revision.
Key topics
- Scope and applicability
- Instruments that perform photon counting and energy discrimination without imaging capability (in vivo and in vitro).
- Routine test methods
- Principles for functional checks, counting performance and energy-response verification (conceptual test descriptions rather than prescriptive device recipes).
- Performance characteristics
- Topics covered conceptually include counting efficiency, energy resolution, linearity and stability under routine conditions.
- Quality assurance and routine maintenance
- Recommendations to support regular acceptance, calibration checks, and operational verification to ensure consistent measurement performance.
- Exclusions and boundaries
- Clear scope exclusions (e.g., Geiger–Mueller counters, dose calibrators) to avoid misapplication of the tests.
Applications and practical value
IEC TR 61948-1:2016 provides practical guidance to ensure reliable operation and comparability of non‑imaging gamma-counting instruments. Typical uses include:
- Manufacturers: design verification and development of routine factory test protocols that align with internationally recognized practices.
- Clinical engineers and hospital physicists: acceptance testing, periodic performance checks, and QA programs for well counters and organ probes used in nuclear medicine laboratories.
- Regulatory bodies and procurement: evaluation criteria for purchase specifications, tender documents and conformity assessment planning.
- Research and calibration labs: establishing repeatable routine tests for in vitro assay equipment and radionuclide counting workflows.
Who should use this standard
- Medical device manufacturers of gamma counting systems
- Clinical engineers, medical physicists and hospital QA teams
- Test laboratories and calibration facilities
- Procurement officers and regulators involved in nuclear medicine equipment
Related standards
- Other IEC and ISO documents addressing nuclear medicine instrumentation, imaging systems, radiation measurement and medical device quality management are typically used alongside IEC TR 61948-1:2016. Users should consult applicable national regulations and complementary IEC/ISO standards for imaging devices, dose measurements and device safety.
Keywords: IEC TR 61948-1:2016, nuclear medicine instrumentation, gamma radiation counting systems, well counters, organ probes, routine tests, photon counting, energy measurement, quality assurance.