IEC TR 62649:2010 PDF

Overview - IEC TR 62649:2010 (HITU / HIFU)

IEC TR 62649:2010 provides guidance on measurement standards for high intensity therapeutic ultrasound (HITU) - also known as high intensity focused ultrasound (HIFU) - used primarily for thermal tissue ablation. The technical report (TC 87, Ultrasonics) reviews scientific literature and global expert responses to identify gaps and priorities for international standardization of the acoustic and safety measurements needed for HITU devices. Lithotripsy and physiotherapy are explicitly excluded because separate standards exist for those applications.

Key topics and technical requirements covered

The report does not prescribe a single measurement method but identifies what measurement standards or technical specifications are needed. Major technical topics and requirements include:

• Measurement of total output power (recommendation to develop as an International Standard or amendment to IEC 61161)
• Specification and measurement of field parameters related to pressure and intensity distributions for focused, high‑intensity fields
• Robust point pressure measurement methods (hydrophone/scanning challenges are discussed)
• Direct and indirect measurement of intensity and relevant parameters for HITU dose control
• Measurement of temperature rise and temperature distribution and thermal dose for thermal ablation applications
• Detection and specification of cavitation activity and nonlinear acoustic effects at very high pressures/intensities
• Registration of the HITU acoustic field with targeting/monitoring systems (treatment alignment)
• Tissue‑mimicking materials for QA and engineering evaluation to simulate in‑vivo response
• Electrical properties of therapeutic transducers, treatment monitoring, equipment safety and essential performance
• Identification of topics that need immediate standard development, near‑term work (≤5 years), and areas requiring further research

The report also reviews limitations of existing measurement methods in high‑intensity, strongly focused and nonlinear acoustic regimes, and includes illustrative measurement setups (e.g., radiation force balance, hydrophone scanning).

Practical applications & who uses this standard

IEC TR 62649:2010 is a resource for stakeholders involved in HITU/HIFU device development and clinical deployment, including:

• Medical device manufacturers (design validation, QA, regulatory submissions)
• Test laboratories and calibration facilities (developing reliable measurement procedures)
• Regulators and conformity assessment bodies (defining essential performance and safety criteria)
• Clinical researchers and hospitals (treatment planning, monitoring, and performance verification)
• Standards developers (prioritizing standardization work and drafting technical specifications)

Related standards

• IEC 61161 (acoustic power measurement) - proposed as a candidate for amendment for HITU power methods
• IEC 60601 series - for equipment safety and essential performance (HITU particular standard recommended)

Keywords: IEC TR 62649:2010, HITU, HIFU, measurement standards, therapeutic ultrasound, acoustic field, thermal dose, hydrophone, radiation force balance, cavitation, QA.