What is BS EN 60601-2-57 - Safety and performance of non-laser light source equipment about?
BS EN 60601 is a European standard that discusses medical electrical equipment. BS EN 60601-2-57 provides basic safety and essential performance of equipment incorporating one or more sources of optical radiation in the wavelength range 200 nm to 3 000 nm, except for laser radiation to ensure the practical degree of safety in the operation of endoscopic equipment.
BS EN 60601-2-57 is intended to create non-visual photobiological effects in humans or animals for therapeutic, diagnostic, monitoring, cosmetic/aesthetic, or veterinary applications; hereafter referred to as light source equipment.
Light source equipment may consist of single or multiple sources of optical radiation, with or without a power supply, or may be incorporated into a complex system that includes optical, electrical, or mechanical systems or sources of other radiation.
Note 1: BS EN 60601-2-57 does not apply to equipment for sun tanning, ophthalmic instruments, or infant phototherapy.
Note 2: Safety requirements in BS EN 60601-2-57 are intended to address only hazards to the eye and skin; hazards to internal tissues are not included in its scope.
Who is BS EN 60601-2-57 - Safety and performance of non-laser light source equipment for?
BS EN 60601-2-57on the safety and performance of non-laser light source equipment are useful for:
- Manufacturers of non-laser light source equipment
- Medical laboratories
- Regulatory authorities
Why should you use BS EN 60601-2-57 - Safety and performance of non-laser light source equipment?
Light source equipment is a piece of medical electrical equipment that incorporates one or more sources of optical radiation in the wavelength range 200 nm to 3 000 nm, except for laser radiation, and that is intended to create non-visual photo-biological effects in humans or animals for therapeutic, diagnostic, monitoring, cosmetic/aesthetic, or veterinary applications.
BS EN 60601-2-57 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 non-laser light source equipment.
BS EN 60601-2-57 also guides on the accuracy of controls, protection against hazardous outputs, hazardous situations, fault conditions, programmable electrical medical systems, and electromagnetic compatibility for non-laser light source equipment.
With obedience and compliance to BS EN 60601-2-57, you can enhance the efficacy and standardise the performance of non-laser light source equipment. In addition, ensure the health and safety of patients and operators.
