IEC 60601-2-62:2013
Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
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About This Item
IEC 60601-2-62:2013 is the technical reference for medical electrical equipment used in high intensity therapeutic ultrasound (HITU) applications, focusing on basic safety and essential performance. It is relevant when organizations need to evaluate how this type of therapeutic equipment should be designed, tested, documented, or reviewed for conformity assessment. For engineering, procurement, and compliance teams, the document supports risk management, verification activities, and technical assessment against a defined safety and performance framework.
Purpose of IEC 60601-2-62:2013
The purpose of IEC 60601-2-62:2013 is to establish particular requirements for high intensity therapeutic ultrasound equipment within the broader medical electrical equipment framework. It is intended to guide manufacturers, test laboratories, and reviewers in assessing basic safety and essential performance for HITU devices. In practice, it supports technical validation, documented evaluation, and engineering documentation by defining a focused compliance reference for equipment that delivers therapeutic ultrasound at high intensity.
Compliance applications of IEC 60601-2-62:2013
This document is commonly used in product development, type testing, and regulatory preparation for HITU systems that must be reviewed before market placement or internal approval. It can support conformity assessment activities, procurement checks, and quality workflows where the safety and performance of therapeutic ultrasound equipment must be demonstrated. Laboratories and compliance teams may use it to structure verification activities, compare design outputs with requirements, and maintain operational consistency across technical review steps.
Benefits of IEC 60601-2-62:2013
Using IEC 60601-2-62:2013 helps organizations align safety and performance expectations for high intensity therapeutic ultrasound equipment with a recognized technical baseline. This can reduce uncertainty during engineering validation, improve testing consistency, and support more efficient conformity assessment preparation. It also provides a clearer basis for compliance workflows, helping teams document risk-related decisions, review essential performance claims, and evaluate whether a product is suitable for procurement or release decisions.
- Particular requirements for the basic safety and essential performance of HITU equipment
- Useful for engineering review, verification testing, and documented compliance assessment
- Supports product evaluation and regulatory preparation for therapeutic ultrasound systems
- Helps testing teams apply consistent criteria during technical validation activities
- Publication Date: 2013-09-07
- Standard Status: Original
- Publisher: IEC
- Edition: 1
- This Version: IEC 60601-2-62:2013 (2013-09-07)
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