What is BS EN 60601-2-64 - Safety and performance of light ion beam medical electrical equipment about?
BS EN 60601 is a European standard that discusses medical electrical equipment. BS EN 60601-2-64 is the sixty-fourth subpart of the second part of a multi-part series that provides the particular requirements for the basic safety and essential performance of light ion beam me equipment, hereafter referred to as me equipment, used for the treatment of patients to ensure electrical and mechanical safety in the operation of light ion beam medical electrical equipment.
BS EN 60601-2-64 with the inclusion of type tests and site tests applies respectively to the manufacture and some installation aspects of light ion beam ME equipment:
- Intended for radiotherapy in human medical practice, including those in which the selection and display of operating parameters can be controlled automatically by programmable electronic subsystems (PESS)
- That, in normal use, deliver a radiation beam of light ions having energy per nucleon in the range 10 MeV/n to 500 MeV/n
intended to be:
- For normal use, operated under the authority of appropriately licensed or qualified persons by operators having the required skills for a particular medical application, for specified clinical purposes maintained under the recommendations given in the instructions for use
- Subject to regular quality assurance performance and calibration checks by a qualified person
Who is BS EN 60601-2-64 - Safety and performance of light ion beam medical electrical equipment for?
BS EN 60601-2-64 on basic safety and performance of light ion beam medical electrical equipment is useful for:
- Manufacturers of endoscopic equipment
- Operators and technical staff for endoscopic equipment
- Medical test laboratories
- Regulatory authorities
Why should you use BS EN 60601-2-64 - Safety and performance of light ion beam medical electrical equipment?
Light ion species of an ion with an atomic number less than or equal to that of neon (Z ≤ 10) and specified by its number of protons, number of nucleons, and ionization state. Light ion beam
Collection of light ions travelling in the same general direction. A light ion beam applicator is a device for holding a beam limiting device or accessory close to the patient's skin during delivery of light ion beam.
BS EN 60601-2-64 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 light ion beam medical electrical equipment.
BS EN 60601-2-64 also provides guidance on the accuracy of controls, protection against hazardous outputs, hazardous situations, fault conditions, programmable electrical medical systems, and electromagnetic compatibility for light ion beam medical electrical equipment.
With obedience and compliance to BS EN 60601-2-64, you can enhance the efficacy and standardise the performance of endoscopic equipment. In addition, ensures the health and safety of patients and operators.
