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For equipment within the scope of IEC 62368-1, which incorporate radiating ultrasound or ultrasonic functions, is it required to document the ultrasound radiation as an RS1 / RS2 / RS3 energy source?

More specifically you asked: For devices that are within the scope of 62368 which incorporate radiating ultrasound or ultrasonic functions, is it required to document the ultrasound radiation as an RS1 / RS2 /RS3 energy source? This is for non-medical purposes with a max. sound level of 85 dBA.

 

In response, IEC 62368-1 and UL 62368-1 Second and Third Editions do not cover ultrasound or ultrasonic requirements in Clause 10 (Radiation) - only radiation hazards, such as Laser, LED, IR and UV are addressed, as well X-Ray and Acoustic Pressure. (For acoustic pressure, the requirements only apply to Portable Music Players, and there is an average sound pressure limit not to exceed 85 dB(A).)

 

For a construction or technology not anticipated by IEC 62368-1, use of sub-clause 4.1.5, Constructions not specifically covered, would be used, which states, “Where the equipment involves technologies, components and materials or methods of construction not specifically covered in this document, the equipment shall provide SAFEGUARDS not less than that generally afforded by this document and the principles of safety contained herein,” in addition to, “The need for additional detailed requirements to cope with a new situation should be brought promptly to the attention of the appropriate committee.”

 

Therefore, since radiating ultrasound or ultrasonic functions are not covered by Clause 10, further research would be required to identify appropriate requirements and limits for units having ultrasonic, ultrasound features. Possible areas for research are but not limited to CTL Decisions (e.g., Sheet # 354 acc. IEC 61010-1; see https://decisions.iecee.org ); or particular requirements of IEC 60601-x; or particular requirements of IEC 60335-x, etc.

 

Also, ideally as a manufacturer producing such equipment falling under the scope of IEC 62368-1, in accordance with 4.1.5, you would consider making a proposal to IEC TC108 via your National Committee on how Clause 10 should address such equipment.

 

The complete answer to this topic is complex, and there appears to be a specific, detailed construction that needs review / analysis. Therefore, you are encouraged to contact UL for an in-depth consultation, either via your local account executive or via https://62368-ul-solutions.com/contact-ul.html.

 

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