IEC TR 62649-2010 PDF

Full title and description

IEC/TR 62649:2010 — Requirements for measurement standards for high intensity therapeutic ultrasound (HITU) devices. This Technical Report reviews measurement, specification and standardization needs for ultrasound fields used in therapeutic applications where fields are both high intensity and focused and the primary mechanism of action is thermal (commonly referred to as HITU or HIFU). It identifies topics suitable for immediate standardization, topics needing technical specifications for practical experience, and topics requiring further research before formal standard development.

Abstract

This technical report surveys scientific literature and international expert input to describe requirements and priorities for measurement standards for high intensity therapeutic ultrasound devices. It excludes lithotripsy and physiotherapy (where other standards exist), and focuses on measurement protocols, field characterisation and metrology appropriate to HITU/HIFU applications. The report recommends areas where international standards or technical specifications should be developed to support consistent measurement, reporting and safety assessments for therapeutic ultrasound fields.

General information

• Status: Technical Report (IEC TR).
• Publication date: 28 April 2010.
• Publisher: International Electrotechnical Commission (IEC), Technical Committee TC 87 (Ultrasonics).
• ICS / categories: 17.140.50 (Ultrasonics).
• Edition / version: Edition 1.0 (2010).
• Number of pages: 93 pages.

Scope

Defines the scope of measurement-standard needs for high intensity therapeutic ultrasound (HITU/HIFU) fields intended for medical therapeutic use. The report examines where consensus exists that international standards would benefit industry and patients, proposes topics for immediate standards development, recommends topics for technical specifications to gain practical experience, and identifies areas that require additional research prior to standardization. Lithotripsy and physiotherapy applications are explicitly excluded because existing standards cover those areas.

Key topics and requirements

• Definitions and characteristics of high intensity therapeutic ultrasound (HITU/HIFU) fields and relevant measurement parameters (intensity, power, focal characteristics, spatial distribution).
• Metrology requirements for measurement standards: required instrumentation, calibration approaches and uncertainty assessment for high-intensity focused fields.
• Recommended measurement methods and field characterisation techniques suitable for thermal-mechanism therapeutic ultrasound.
• Guidance on reporting formats and minimum information for reproducible measurement and comparison between devices and laboratories.
• Prioritisation of topics for immediate standard development, for technical specifications to gather experience, and for areas needing further research.
• Considerations for safety-related measurements and their role in device specification and clinical use.

Typical use and users

Used by standards developers, national metrology institutes and calibration laboratories, medical device manufacturers (HITU/HIFU device designers and test groups), clinical/medical physicists involved in therapeutic ultrasound, and regulatory bodies setting measurement and safety requirements. It guides researchers and test houses in selecting measurement approaches and identifying gaps where further standardization or research is needed.

Related standards

Related materials include other IEC standards and technical reports addressing medical ultrasonic equipment, measurement methods and medical electrical equipment safety (see work of IEC TC 87 — Ultrasonics — and applicable parts of the IEC 60601 series for medical electrical equipment). The report explicitly notes that standards for lithotripsy and physiotherapy exist and should be consulted for those specific applications.

Keywords

HITU, HIFU, therapeutic ultrasound, measurement standards, ultrasound metrology, field characterisation, acoustic power, calibration, IEC TR 62649, ultrasonic therapy.

FAQ

Q: What is this standard?

A: IEC/TR 62649:2010 is a Technical Report published by the IEC (TC 87: Ultrasonics) that surveys measurement and standardization needs for high intensity therapeutic ultrasound devices and recommends topics for future standards and technical specifications.

Q: What does it cover?

A: It covers metrology and measurement-standard requirements for HITU/HIFU fields (primarily thermal-mechanism therapeutic ultrasound), including measurement parameters, calibration considerations, recommended measurement approaches, reporting guidance, and prioritisation of standardization activities. Lithotripsy and physiotherapy are excluded.

Q: Who typically uses it?

A: Standards bodies, metrology and calibration labs, medical device manufacturers, clinical physicists, researchers in therapeutic ultrasound, and regulatory reviewers use the report to inform measurement practice and standards development.

Q: Is it current or superseded?

A: IEC/TR 62649:2010 is the 2010 Technical Report (Edition 1.0). The IEC webstore indicates the document's stability/validity information as published with a stability date shown on the IEC record; users should check the IEC catalogue or national standards body for any amendments, corrigenda or newer related publications before relying on it for regulatory compliance.

Q: Is it part of a series?

A: It is a Technical Report issued by IEC TC 87 (Ultrasonics) and complements other IEC documents and standards on medical ultrasonic equipment and metrology; it is not a numbered part of a multipart standard but serves as a guidance and scoping document to inform future standards and technical specifications.

Q: What are the key keywords?

A: HITU, HIFU, therapeutic ultrasound, measurement standards, acoustic power, focal field characterisation, ultrasound metrology, calibration.