prБДС EN ISO 12609-1:2021

Eye and face protection against intense light sources used on humans and animals for cosmetic and medical applications - Part 1: Specification for products (ISO/FDIS 12609-1:2021)

Scope

This document specifies general requirements for operators' eye protectors for intense light source (ILS) equipment used on humans and animals for cosmetic and medical applications against excessive exposure to optical radiation in the spectral range 250 nm to 3 000 nm, with the exception of laser radiation.
This document is applicable to devices intended for patient protection during ILS procedures, except for treatment in the periorbital area. For guidance on patient eye protection during ILS procedures, see ISO/TR 22463.
For guidance on the use and selection of ILS eye protectors, see ISO 12609-2.
This document does not apply to:
—    laser protectors, for which ISO 19818-1 applies;
—    protectors for medically prescribed applications (not occupational), e.g. eye protection for severe dry eye, tints prescribed for medical conditions;
—    protectors specifically intended for protection against only solar radiation and used in non-occupational environments for which the ISO 12312 (all parts) applies;
—    protectors used with tanning equipment;
—    protectors intended to protect against ionizing radiation, e.g. X-rays, for which IEC 61331-3 applies.

Directives and Regulations

When the standard is harmonized under a directive or regulation, the word Harmonized appear. When such an inscription does not appear, it means that the standard is related to / supporting the relevant directive or regulation.