What is BS EN 60601-2-5 - Safety and essential performance of ultrasonic physiotherapy equipment about?
BS EN 60601-2-5 is the second subpart of the fifth part of the multi-series standard that is applicable to medical electrical equipment.
BS EN 60601-2-5 applies to the basic safety and essential performance of ULTRASONIC PHYSIOTHERAPY EQUIPMENT as defined in 201.3.216, hereafter referred to as ME EQUIPMENT.
BS EN 60601-2-5 only relates to ULTRASONIC PHYSIOTHERAPY EQUIPMENT employing a single plane unfocused circular transducer per TREATMENT HEAD, producing static beams perpendicular to the face of the TREATMENT HEAD.
Note-
BS EN 60601-2-5 does not apply to:
- EQUIPMENT in which a tool is driven by ULTRASOUND (for example EQUIPMENT used in surgery or dentistry)
- EQUIPMENT in which focused ULTRASOUND pulse waves are used to destroy conglomerates such as stones in the kidneys or the bladder (lithotripters) (for information refer to IEC 60601-2-36)
- ULTRASONIC PHYSIOTHERAPY EQUIPMENT in which focused ultrasound pulse waves are used
Who is BS EN 60601-2-5 - Safety and essential performance of ultrasonic physiotherapy equipment for?
BS EN 60601-2-5 on safety and essential performance of ultrasonic physiotherapy equipment is useful for:
- Doctors
- Manufacturers of ultrasonic physiotherapy equipment
- Healthcare facilities
- Radiotherapy laboratories
- Healthcare professionals
Why should you use BS EN 60601-2-5 - Safety and essential performance of ultrasonic physiotherapy equipment?
ULTRASONIC PHYSIOTHERAPY EQUIPMENT is EQUIPMENT for the generation and application of ULTRASOUND to a PATIENT for therapeutic purposes.
BS EN 60601-2-5 applied to ULTRASONIC PHYSIOTHERAPY EQUIPMENT that you can use for compensation or alleviation of disease, injury or disability. BS EN 60601-2-5 only specifies ME EQUIPMENT and ME SYSTEMS overall, BS EN 60601-2-5 helps you to establish particular basic safety and essential performance requirements for ULTRASONIC PHYSIOTHERAPY EQUIPMENT.
What’s changed since the last update?
BS EN 60601-2-5:2015 supersedes BS EN 60601-2-5:2001, which will be withdrawn.