What is BS EN 60601-2-36 - Safety and performance of equipment for extracorporeally induced lithotripsy about?
BS EN 60601 is a European standard that discusses medical electrical equipment. BS EN 60601-2-36 is the thirty-sixth subpart of the second part of a multi-part series that provides the particular requirements for the basic safety and performance of equipment for extracorporeally induced lithotripsy to ensure the practical degree of safety in the operation of equipment for extracorporeally induced lithotripsy.
BS EN 60601-2-36 includes equipment for other medical applications of therapeutic extracorporeally induced focused pressure pulses, hereafter referred to as me equipment.
The applicability of BS EN 60601-2-36 is limited to components directly involved in the lithotripsy treatment, such as but not limited to, the generator of the pressure pulse, patient support device, and their interactions with imaging and monitoring devices.
Note 1: other devices, such as patient treatment planning computers, X-ray and ultrasonic devices, are excluded from BS EN 60601-2-36 because they are treated in other applicable IEC standards.
Note 2: BS EN 60601-2-36 does not apply to:
- Ultrasound physiotherapy equipment intended to be used for physiotherapy
- Ultrasound equipment intended to be used for high-intensity therapeutic ultrasound (HITU) and other therapy equipment as described in Annex AA
Who is BS EN 60601-2-36 - Safety and performance of equipment for extracorporeally induced lithotripsy for?
BS EN 60601-2-36 on basic safety and performance of equipment for extracorporeally induced lithotripsy is useful for:
- Manufacturers of equipment for extracorporeally induced lithotripsy
- Operators and technical staff for equipment for extracorporeally induced lithotripsy
- Medical test laboratories
- Regulatory authorities
Why should you use BS EN 60601-2-36 - Safety and performance of equipment for extracorporeally induced lithotripsy?
Extracorporeally induced lithotripsy is lithotripsy inside the patient by pressure pulses generated outside the patient.
BS EN 60601-2-36 guideline assists you with general requirements for testing of medical electrical equipment, protection against electrical hazards, protection against mechanical hazards, protection against unwanted, protection against excessive radiation hazards, protection against excessive temperatures, and other hazards for basic safety and essential performance of endoscopic equipment.
BS EN 60601-2-36 also provides guidance on the accuracy of controls, protection against hazardous outputs, hazardous situations, fault conditions, programmable electrical medical systems, and electromagnetic compatibility for endoscopic equipment.
With obedience and compliance to BS EN 60601-2-36, you can enhance the efficacy and standardise the performance of endoscopic equipment. In addition, ensures the health and safety of patients and operators.