BS EN IEC 63045:2020

What is IEC 63045 about? 

IEC 63045 is applicable to: 

• Therapy equipment using extracorporeally induced non-focused or weakly focused pressure pulses 
• Therapy equipment producing extracorporeally induced non-focused or weakly focused mechanical energy where the pressure pulses are released as single events of duration up to 25 μs. 

IEC 63045 specifies: 

• Measurable parameters which are used in the declaration of the acoustic output of extracorporeal equipment producing a non-focused or weakly focused pressure pulse-field 
• Methods of measurement and characterization of non-focused or weakly focused pressure pulse fields 

IEC 63045 has been developed for equipment intended for use in pressure pulse therapy, for example, therapy of orthopaedic pain like shoulder pain, tennis elbow pain, heel spur pain, muscular trigger point therapy, lower back pain, etc. 

NOTE 1: The parameters defined in IEC 63045 do not – at the time of publication – allow quantitative statements to be made about clinical efficacy and possible hazard. In particular, it is not possible to make a statement about the limits for these effects 

NOTE 2: IEC 63045 is not intended to be used for extracorporeal lithotripsy equipment 

Who is IEC 63045 for?  

IEC 63045 on ballistic pressure pulse sources is beneficial for: 

• Biomedical engineers 
• People working on pressure controllers and transducers 
• Manufacturers of ultrasonic transducer kits 
• Civil engineers 

Why should you use IEC 63045? 

In this document, pressure pulses are single pulses of ultrasonic energy of up to 25 μs duration which have only one significant positive and one negative peak carrying more than 95 % of the energy. 

Focused pressure pulses (sometimes called "strongly focused") are characterized by a peak acoustic pressure in a point in the sound field distant from the source aperture. The parameters and measurement methods of any other types of pressure pulses, i.e., weakly focused and non-focused pressure pulses, are described in IEC 63045. IEC 63045 assists the user on devices with non-focusing/weakly focusing pressure pulse sources that are used for the extracorporeal treatment of soft tissue pain situations in, for example, the shoulder, the heel spur, or the tennis elbow and for trigger point therapy. The first devices used the ballistic principle for the generation of the pressure pulses, which is based on an "air-gun" like acceleration of a projectile by pressurized air. Other pulses generating principles are being applied in IEC 63045 including variations of common lithotripter sources (electromagnetic, piezoelectric, electrohydraulic). IEC 63045 specifies methods of measuring and characterizing the acoustic pressure pulses generated by non-focusing/weakly focusing pressure pulse equipment and their propagation characteristics. 

Overall, IEC 63045 about the pressure pulse consists of one significant compressional part and a trailing negative part and have an overall duration of fewer than 25 μs. In present devices, 1 to 35 pulses per second are released to the target tissue. The pulses are usually applied to the patient by a manually guided handpiece.