BS EN IEC 60601-2-2:2018

What is BS EN IEC 60601‑2‑2 - HF surgical equipment and HF surgical accessories about?  

BS EN IEC 60601‑2‑2 is the second part of the multi-series international standard that focuses on medical electrical equipment with the particular requirement for the basic safety essential performance. BS EN IEC 60601‑2‑2 applies to the basic safety and essential performance of HF surgical equipment and HF surgical accessories HF surgical equipment having a rated output power not exceeding 50 W (for example for micro-coagulation or use in dentistry or ophthalmology) is exempt from certain of the requirements of BS EN IEC 60601‑2‑2. These exemptions are indicated in the relevant requirements. 

Who is BS EN IEC 60601‑2‑2 - HF surgical equipment and HF surgical accessories for? 

BS EN IEC 60601‑2‑2 on medical electrical equipment with the particular requirement for the basic safety essential performance is useful for: 

• The engineers who are involved in the manufacturing of medical electrical equipment 
• The professional technicians  
• The person who can demonstrate the medical electrical equipment to the end-user 

Why should you use BS EN IEC 60601‑2‑2 - HF surgical equipment and HF surgical accessories?  

The minimum safety requirements specified in BS EN IEC 60601‑2‑2 are considered to provide for a practical degree of safety in the operation of high-frequency surgical equipment. The object of BS EN IEC 60601‑2‑2 is to establish basic safety and essential performance requirements for HF surgical equipment and HF surgical accessories. 

BS EN IEC 60601‑2‑2 is intended to be used by the operator to produce an effect by electrical conduction adjacent to the active electrode at the intended site on the patient, generally comprising an active handle, the cord of an active accessory, active connector and active electrode. 

BS EN IEC 60601‑2‑2 will not only facilitate the proper application of the standard but will, in due course, expedite any revision necessitated by changes in clinical practice or as a result of developments in technology. 

What’s changed since the last update? 

BS EN IEC 60601‑2‑2:2018 supersedes BS EN 60601‑2‑2:2009+A11:2011. BS EN IEC 60601‑2‑2:2018 includes some technical changes concerning BS EN 60601‑2‑2:2009+A11:2011. These include: 

• Refinement and additions to the defined terms 
• Additional separation of the requirements for hf surgical equipment and hf surgical accessories 
• A new requirement for adult neutral electrodes to contact quality monitoring neutral electrodes 
• New requirements for devices that have or use a high current mode