IEC 60601-2-57 Ed. 2.0 b:2023
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Medical electrical equipment – Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
This part of IEC 60601-2 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, and cosmetic or aesthetic applications; hereafter referred to as light source equipment (LS EQUIPMENT).
This document applies to LS EQUIPMENT of RISK GROUP 1C if the incorporated source of OPTICAL RADIATION is of RG-3, and of Risk Group 3.
NOTE 1 For classification rules for Risk Groups, see 201.6.1.102.
This document does not apply to equipment for sun tanning such as sunlamp products, for ophthalmic instruments, for lighting purposes in medical or 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 document does not apply to sterilization equipment.
This document 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 2 Home-use appliances are covered by IEC 60335-2-113:2016 [1]1. Appliances for skin exposure to OPTICAL RADIATION, such as sunlamp products, are covered by IEC 60335-2-27 [2]. 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), are also covered by IEC 60601-2-83:2019 [3].
NOTE 3 Safety requirements in this document 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 millimetres in tissue, HAZARDS to underlying tissues are not considered.
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