ISO 23158 is officially titled:
“Ultrasonics — Medical diagnostic and monitoring equipment — Characteristics of ultrasonic physiotherapy systems”
This standard outlines:
It applies to both manufacturers of therapeutic ultrasound devices and healthcare providers who use and maintain such equipment.
Ultrasonic physiotherapy systems are widely used to treat:
Despite their popularity, poor calibration or inconsistent performance can lead to ineffective therapy or patient injury. ISO 23158 ensures that:
This standard is essential for medical device manufacturers, rehabilitation equipment suppliers, hospitals, and physiotherapy clinics.
Implementing ISO 23158 into your development or clinical practice brings key advantages:
Adopting ISO 23158 yields measurable business benefits, including:
Simplify approvals in global markets by meeting international device performance requirements.
Gain a reputation for manufacturing or supplying reliable and safe physiotherapy equipment.
Use ISO 23158 compliance as a key selling point in tenders, exports, and clinical procurement.
Minimize risk of adverse effects, complaints, or legal claims from improperly functioning devices.
Maintain long-term performance consistency with ISO-aligned maintenance and calibration practices.
Complementary to clinical evaluations and product safety data for regulatory submissions.
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