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  • BSI
    BS EN ISO 15004-2:2024 Ophthalmic instruments. Fundamental requirements and test methods - Light hazard protection
    Edition: 2025
    $516.89
    / user per year

Description of BS EN ISO 15004-2:2024 2025

This document specifies fundamental requirements for optical radiation safety for ophthalmic instruments and is applicable to all ophthalmic instruments that direct optical radiation into or at the eye. It is also applicable to all new and emerging ophthalmic instruments that direct optical radiation into or at the eye, as well as to those portions of therapeutic or surgical systems that direct optical radiation into or at the eye for diagnostic, illumination, measurement, imaging or alignment purposes. NOTE            For the purpose of this document, optical radiation relates to the wavelength range of 250 nm to 2 500 nm. This document does not apply to therapeutic radiation. However, in the case of the treatment beams of therapeutic devices, when conducting risk assessments for non-target tissues, the limits given in this document may be applied to those parts of the treatment beam that strike non-target tissue. Where vertical (instrument-specific) International Standards contain specific light hazard requirements different from those given in ISO 15004-2, then those in the vertical International Standard take precedence. This document classifies ophthalmic instruments into either Group 1 or Group 2 to distinguish instruments that are non-hazardous from those that are potentially hazardous.

Standard NumberBS EN ISO 15004-2:2024
TitleOphthalmic instruments. Fundamental requirements and test methods - Light hazard protection
StatusDefinitive
Publication Date2025-01-23
ReplacesBS EN ISO 15004-2:2007
Identical National Standard OfEN ISO 15004-2, ISO 15004-2
DescriptorsLight emission, Ophthalmology, Light hazards, Safety measures, Medical equipment, Eyes, Optical measurement, Wavelengths, Equipment safety, Instructions for use, Classification systems, Optical instruments, Ophthalmic equipment, Clinical investigation instruments, Hazards
ICS11.040.70 Ophthalmic equipment
CommitteeCH/172/6
ISBN978 0 539 12098 1
PublisherBSI
Pages66

The following editions for this book are also available...

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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