BS EN IEC 63009:2019

What is BS EN IEC 63009 - Ultrasonics about? 

BS EN IEC 63009 is a safety standard on ultrasonics for physiotherapy systems. 

BS EN IEC 63009 is applicable to ultrasonic equipment designed for physiotherapy containing an ultrasonic transducer generating ultrasound in the frequency range 20 kHz to 500 kHz. 

BS EN IEC 63009 specifies: 

• Methods of measurement and characterization of the output of ultrasonic physiotherapy equipment based on reference testing methods 
• Characteristics to be specified by manufacturers of ultrasonic physiotherapy equipment 
• Methods of measurement and characterization of the output of ultrasonic physiotherapy equipment based on routine testing methods 
• Acceptance criteria for aspects of the output of ultrasonic physiotherapy equipment 

Note 1: The therapeutic value and methods of use of ultrasonic physiotherapy equipment are not within the scope of BS EN IEC 63009. 

Note 2: Excluded equipment includes, but is not limited to: 

• Equipment in which ultrasound waves are intended to destroy conglomerates (for example stones in the kidneys or the bladder) or tissue of any type 
• Equipment in which a tool is driven by ultrasound (for example surgical scalpels, phacoemulsifiers, dental scalers, or intracorporeal lithotripters) 
• Equipment in which ultrasound waves are intended to sensitize a tissue to further therapies (for example radiation or chemotherapy) 
• Equipment in which ultrasound waves are intended to treat cancerous (i.e., malignant) or pre-cancerous tissue, or benign masses, such as High-Intensity Focused Ultrasound (HIFU) or High-Intensity Therapeutic Ultrasound (HITU) 

Note 3: This document only relates to ultrasonic physiotherapy equipment employing a single plane non-focusing circular transducer per treatment head, producing static beams perpendicular to the face of the treatment head. 

Who is BS EN IEC 63009 - Ultrasonics for?  

BS EN IEC 63009 on ultrasonics for physiotherapy systems is relevant to: 

• Manufacturers of ultrasonic physiotherapy equipment  
• Manufacturers of hydrophone 
• Manufacturers of test vessels 
• Testing authorities 
• Health professionals  
• Physiotherapists 

Why should you use BS EN IEC 63009 - Ultrasonics? 

Ultrasound is used in medicine for the purposes of physiotherapy. 

BS EN IEC 63009 assists the user with the equipment that consists of a generator of electrical energy and usually a hand-held treatment head, often referred to as an applicator. The treatment head contains a transducer for converting the electrical energy to ultrasound and is often designed for contact with the human body. BS EN IEC 63009 provides guidance on the frequency of an acoustic signal based on the observation of the output of a hydrophone placed in an acoustic field at the position corresponding to the spatial-peak temporal-peak acoustic pressure or 0,3 cm, whichever is greater. 

Overall, BS EN IEC 63009 is useful as it helps in determining the effective radiating area of the treatment head for the purposes of reference measurements.