Medical electrical equipment - Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

Medical electrical equipment - Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

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What is BS EN IEC 60601-2-22 about?  

BS EN IEC 60601-2-22 discusses medical electrical equipment. BS EN IEC 60601-2-22 provides safety requirements and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment. BS EN IEC 60601-2-22 specifies the hazards inherent in the intended physiological function of laser equipment. 

Who is BS EN IEC 60601-2-22 for? 

BS EN IEC 60601-2-22 on safety requirements and essential performance of laser equipment is useful for: 

  • Medical laser equipment manufacturers 
  • Laser equipment suppliers 
  • Medical staff 
  • Buyers 

Why should you use BS EN IEC 60601-2-22?  

Lasers have been of growing interest and specifically their use in medical institutions. Accidents may occur with patients as well with users of the laser, or laser handlers and also to people passing in front of the laser treatment room. The risk associated with the laser, most of them can be prevented by good training, use of proper protective equipment, and ensuring the safe operation of the laser.  

BS EN IEC 60601-2-22 provides a minimum that needs to be complied with, in order to achieve a reasonable level of safety and reliability during the operation and application of medical laser equipment.  

BS EN IEC 60601-2-22 provides adequate instructions for proper operation, maintenance, including clear warnings concerning precautions to avoid possible exposure to hazardous laser radiation. 

What’s changed since the last update?  

BS EN IEC 60601-2-22:2020 cancels and replaces EN 60601-2-22:2013. 

BS EN IEC 60601-2-22:2020 includes the following significant technical changes with respect to the EN 60601-2-22:2013 

  • It takes account of IEC 60601-1:2005/AMD1:2012 and IEC 60825-1:2014, which have 
    been published since the publication of the EN 60601-2-22:2013; 
  • It addresses technical and safety issues; 
  • The scope differs. It now includes CLASS 1C laser equipment, as defined in IEC 60825-1:2014, when the ENCLOSED LASER is CLASS 3B or 4; 
  • LED (light-emitting diode) products are now excluded as medical LED products may be covered by IEC 60601-2-57.