IEC TS 62736:2016

Overview

IEC TS 62736:2016 - Ultrasonics - Pulse‑echo scanners - Simple methods for periodic testing to verify stability of an imaging system’s elementary performance - provides practical, repeatable test methods for periodic quality control (QC) of diagnostic medical ultrasound imaging systems. The Technical Specification covers a broad range of transducer types (linear, curved linear, single element, annular, phased array, matrix linear and 2‑D arrays) and focuses on simple measurement procedures to verify ongoing stability of basic imaging performance.

Key Topics

• Scope and purpose: Periodic testing methods to confirm stability of elementary performance of pulse‑echo scanners used in clinical practice.
• Quality control levels: A tiered approach with Level 1 (basic visual/operational checks), Level 2 (simple measurement tests using phantoms and image analysis), and Level 3 (quantitative measurements for depth penetration, distance accuracy and display).
• Test methods and procedures: Mechanical inspection, image uniformity and transducer/channel integrity checks, maximum relative depth of penetration assessments, distance measurement verification, and display/archiving considerations.
• Equipment and data requirements: Use of tissue‑mimicking phantoms, recommended image acquisition settings, digital image data handling and image‑archiving systems for QC records.
• Environmental and operational recommendations: Consideration of environmental conditions and system settings to ensure repeatable measurements.
• Analysis and documentation: Guidance on image analysis, examples of phantoms, and use of control charts/software for tracking performance over time.

Applications

• Routine periodic QC for ultrasound departments in hospitals and clinics to ensure consistent diagnostic image quality and patient safety.
• Preventive maintenance and service verification by biomedical engineers and service technicians to detect transducer element or channel failures.
• Quality assurance programs led by clinical physicists or imaging managers to meet institutional or regulatory expectations for medical imaging equipment.
• Manufacturers and suppliers can use the TS to define basic performance checks and expectations for field support and warranty servicing.

Who Should Use This Standard

• Biomedical engineers and service personnel
• Clinical medical physicists and QA technologists
• Ultrasound department managers and sonographers involved in QC programs
• Manufacturers and suppliers of diagnostic ultrasound equipment

Related Standards (if applicable)

IEC TS 62736 complements other IEC and international guidance on medical ultrasound and medical electrical equipment performance and safety. Users should consult their national requirements and additional IEC publications on ultrasound test methods and medical device standards for comprehensive compliance.

Keywords: IEC TS 62736:2016, ultrasonics, pulse‑echo scanners, ultrasound QC, periodic testing, image uniformity, depth of penetration, transducer testing, diagnostic medical ultrasound.