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IEC 62359:2010/AMD1:2017

Amendment 1 - Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields

Standard by IEC, 2017-09-29

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About This Item

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IEC 62359:2010/AMD1:2017 provides a focused amendment to the technical framework for ultrasonics field characterization, specifically addressing test methods used to determine thermal and mechanical indices related to medical diagnostic ultrasonic fields. For engineering, laboratory, and compliance teams, IEC 62359:2010/AMD1:2017 is relevant when evaluating how ultrasonic exposure is characterized and documented for medical diagnostic applications. It supports more consistent technical review, verification activities, and conformity assessment planning around a sensitive area of device performance and safety-related evaluation.

Overview of IEC 62359:2010/AMD1:2017

This amendment is connected to IEC 62359:2010 and should be read as a modifying reference rather than a standalone technical document. Its scope is centered on test methods used to determine thermal and mechanical indices for medical diagnostic ultrasonic fields, which are commonly used in engineering assessment and risk management for ultrasound systems. IEC 62359:2010/AMD1:2017 is therefore useful for teams that need a compliance reference for documented evaluation, technical validation, and consistency in measurement-related workflows.

Compliance applications of IEC 62359:2010/AMD1:2017

Organizations involved in medical ultrasound product evaluation may use IEC 62359:2010/AMD1:2017 during laboratory evaluation, product verification, and conformity assessment preparation. It is particularly relevant where test methods must support reliable determination of thermal and mechanical indices in diagnostic ultrasonic fields. Procurement teams, test houses, and regulatory groups may consult it when aligning internal procedures, review criteria, or technical documentation with the parent document and its amendment history. IEC 62359:2010/AMD1:2017 can help support repeatable testing workflows and clearer engineering documentation.

Importance of compliance with IEC 62359:2010/AMD1:2017

Compliance with IEC 62359:2010/AMD1:2017 matters because consistent test methods help reduce ambiguity in technical assessment and support safer, more defensible evaluation of medical diagnostic ultrasonic fields. For manufacturers and laboratories, using the amendment alongside the parent reference can improve testing consistency, quality workflows, and regulatory preparation. It also supports procurement review and internal acceptance criteria by giving stakeholders a clearer basis for comparing results, documenting assumptions, and managing compliance risk during product development and verification.

  • Supports test methods for evaluating thermal and mechanical indices in diagnostic ultrasound fields
  • Acts as an amendment linked to IEC 62359:2010 for controlled technical use
  • Useful for laboratory evaluation, verification activities, and conformity assessment planning
  • Helps improve documentation quality and consistency in medical ultrasound compliance workflows
SKU: a3d0ac2d2107

  • Publication Date: 2017-09-29
  • Standard Status: Amendment
  • Publisher: IEC
  • Edition: 2

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