DANSK DSF/PREN IEC 60601-2-57 PDF

This particular Standard applies to 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, with the exception of laser radiation, and intended to create photobiological effects in humans for therapeutic, diagnostic, monitoring, or cosmetic/aesthetic applications; hereafter referred to as light source equipment (LS EQUIPMENT). This particular standard applies to LS EQUIPMENT of Risk Group 1C (but only if the embedded source of OPTICAL RADIATION is of RG-3), and of Risk Group 3. Note: Classification rules for Risk Groups, see 201.6.1.102 This particular standard does not apply to equipment for sun tanning such as sunlamp products, for ophthalmic instruments, for lighting purposes in medical/cosmetic environments, for photography/video, for equipment which produces visual or non-visual effects such as circadian entrainment, or for infant phototherapy and infant radiant warmers. This particular standard does not apply to sterilisation equipment. This particular standard does not apply to home-use appliances. It does not apply to home light therapy equipment, such as equipment which is intended to be used in the HOME HEALTHCARE ENVIRONMENT and is typically used by a LAY OPERATOR. Note: Home-use appliances are covered by IEC 60335-2-113:2016. Appliances for skin exposure to OPTICAL RADIATION, such as sunlamp products are covered by IEC 60335-2-27. Home light therapy equipment providing light therapy by means of eye-mediated photobiological effects, which can be visual or non-visual, and skin-mediated photobiological effects, possible applications including pain relief, psoriasis treatment, and treatment of winter depression (SAD), is covered by IEC 60601-2-83:2019. See Bibliography. Note: Safety requirements in this particular standard are intended to address only HAZARDS to the eye and superficial tissues including skin or mucosa. As OPTICAL RADIATION does not penetrate more than a few mm in tissue, HAZARDS to underlying tissues are not considered