BS EN 60601-2-62:2015

What is BS EN 60601-2-62- High-intensity therapeutic ultrasound (HITU) equipment about? 

BS EN 60601-2-62 applies to the basic safety and essential performance of high-intensity therapeutic ultrasound equipment. 

BS EN 60601-2-62 adds clauses listed in the IEC 60601-1 that are specific for high-intensity therapeutic ultrasound equipment. 

BS EN 60601-2-62 is applied to: 

• Therapeutic equipment for thrombolysis through exposure to high-intensity therapeutic ultrasound 
• Therapeutic equipment for the treatment of occluding feeding vessels through exposure to high-intensity focused ultrasound 
• Equipment intended to be used for relieving cancer pain due to bone metastases 

Note 1: A rationale for the more important requirements, where appropriate, is given in Annex AA of BS EN 60601-2-62. 

Note 2: BS EN 60601-2-62 does not apply to: 

• Ultrasound equipment intended to be used for physiotherapy (use: IEC 60601-2-5 [1]2) and IEC 61689) 
• Ultrasound equipment intended to be used for lithotripsy (use: IEC 60601-2-36 [2]) 
• Ultrasound equipment intended to be used for dedicated hyperthermia devices 
• Ultrasound equipment intended to be used for phacoemulsification 

Who is BS EN 60601-2-62- High-intensity therapeutic ultrasound (HITU) equipment for?  

BS EN 60601-2-62 on high-intensity therapeutic ultrasound (HITU) equipment is relevant to: 

• Manufacturers of high-intensity therapeutic ultrasound (HITU) equipment 
• Manufacturers of imaging transducers 
• Medical equipment manufacturers 
• Electro-medical companies 
• Medical personnel 
• Medical device testing authorities  

Why should you use BS EN 60601-2-62- High-intensity therapeutic ultrasound (HITU) equipment? 

High-intensity therapeutic ultrasound (HITU) equipment is a high-intensity focused ultrasound in which the waves are used for investigating health issues. It opens a new field of applications for ultrasounds in the medical sector.   

It is considered that knowledge of the reasons for these requirements will not only facilitate the proper application of the standard but will, at the right time, expedite any revision necessitated by changes in clinical practice or because of developments in technology. BS EN 60601-2-62 is a safety standard that provides additional requirements to those given in the general standard and serves the purpose to establish basic safety and essential performance requirements specified for high-intensity therapeutic ultrasound (HITU) equipment. BS EN 60601-2-62 provides you with a method for reducing the measurement volume of the field of a High-Intensity Therapeutic Ultrasound (HITU) transducer. BS EN 60601-2-62 provides guidance on high-intensity therapeutic ultrasound (HITU) equipment which can be useful for the generation and application of ultrasound to a patient for therapeutic purposes with the intention to destroy, disrupt or denature living tissues or non-tissue elements. 

Overall, BS EN 60601-2-62 is beneficial for its users as it aims notably at making treatments through actions of ultrasound having mechanical, thermal, or more generally physical, chemical, or biochemical effects.