What is BS EN 60601-2-11 – Basic safety and essential performance of gamma beam therapy equipment about?
BS EN 60601-2-11 is an international standard that focuses on the basic safety and essential performance of gamma beam therapy equipment. BS EN 60601-2-11 applies to the basic safety and essential performance of gamma beam therapy equipment, including multi-source stereotactic radiotherapy equipment, hereafter referred to as medical electrical equipment. The object of BS EN 60601-2-11 is to establish particular basic safety and essential performance requirements for gamma beam therapy equipment.
Who is BS EN 60601-2-11 - Basic safety and essential performance of gamma beam therapy equipment for?
BS EN 60601-2-11 on basic safety and essential performance of gamma beam therapy equipment is useful for:
- Doctors
- Manufacturers of gamma beam therapy equipment for radiotherapy
- Healthcare facilities
- Radiotherapy laboratories
- Healthcare professionals
Why should you use BS EN 60601-2-11 - Basic safety and essential performance of gamma beam therapy equipment?
The use of gamma beam therapy equipment for radiotherapy purposes may expose patients to danger if the medical electrical equipment fails to deliver the required dose to the patient, or if the medical equipment design does not satisfy standards of electrical and mechanical safety. The medical electrical equipment may also cause danger to persons in the vicinity of the medical electrical equipment itself fails to contain the radiation adequately or if there are inadequacies in the design of the treatment room.
BS EN 60601-2-11 establishes requirements to be complied with by manufacturers in the design and construction of gamma beam therapy equipment. BS EN 60601-2-11 also informs that before installation, a manufacturer can provide a compliance certificate relating only to type tests. data available from site tests should be incorporated in the accompanying documents, in the form of a site test report, by those who test the medical electrical equipment after installation.
What’s changed since the last update?
BS EN 60601-2-11:2015 supersedes BS EN 60601-2-11:1998 which has been withdrawn. BS EN 60601-2-11:2015 has been editorially revised.
