UNE-EN IEC 60601-2-57:2026

201.1 Scope, object and related standards

Clause 1 of the general standard2) applies, except as follows:

201.1.1 *Scope

Replacement:

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.

201.1.2 Object

Replacement:

The objects of this particular standard are:

to establish the risk from OPTICAL RADIATION, specify basic safety and essential performance requirements for LS EQUIPMENT;

to specify requirements for the MANUFACTURER to supply information and establish procedures so that proper precautions can be adopted;

to provide warning to individuals of risks associated with accessible OPTICAL RADIATION from LS EQUIPMENT through signs, labels and instructions;

to reduce the possibility of adverse effects and injuries by minimizing unnecessary accessible OPTICAL RADIATION; to provide means of improved control of the HAZARDS related to OPTICAL RADIATION through engineering controls;

to specify requirements for protection against other HAZARDS resulting from the operation and use of LS EQUIPMENT.