Standard No.:	GB 47498.2-2026
English Name:	Ophthalmic instruments—Fundamental requirements and test methods—Part 2：Light hazard protection
Chinese Name:	眼科仪器 基本要求和试验方法 第2部分：光危害防护
Chinese Classification:	C40    Medical optical instrument and endoscope
Professional Classification:	GB    National Standard
ICS Classification:	11.040.70 11.040.70    Ophthalmic equipment 11.040.70
Source Content Issued by:	SAMR, SAC
Issued on:	2026-04-30
Implemented on:	2029-5-1
Status:	to be valid
Target Language:	English
File Format:	PDF
Word Count:	31000 words
Translation Price(USD):	930.0
Delivery:	via email in 1 business day

Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection 1 Scope This document specifies fundamental requirements for optical radiation safety for ophthalmic instruments and describes the corresponding test methods. This document is applicable to all 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. It is also applicable to therapeutic light from ophthalmic therapeutic equipment that irradiates non-target tissues. Where instrument-specific standards contain specific light hazard requirements different from those given in this document, then those in the specific standard take precedence. This document is not applicable to therapeutic light from therapeutic equipment that irradiates target tissues. Note: For the purpose of this document, optical radiation relates to the wavelength range of 250nm to 2,500nm. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB 9706.1-2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1: 2012, MOD) GB/T 31523.1-2015 Safety information identification systems - Part 1: Signs (ISO 7010:2011, MOD) GB/T 47498.1 Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (GB/T 47498.1-2026, ISO 15004-1: 2020, MOD) 3 Terms and definitions For the purposes of this document, the terms and definitions given in GB/T 47498.1 and the following apply. 3.1 aperture aperture stop opening that defines the area over which average optical emission is measured Note: For spectral irradiance measurements, this opening is usually the entrance of a small integrating sphere placed in front of the radiometer/spectroradiometer entrance slit.

Foreword i Introduction iii 1 Scope 2 Normative references 3 Terms and definitions 4 Classification principles 5 Requirements for classification 6 Test methods 7 Information supplied by the manufacturer Annex A (Normative) Spectral weighting functions Annex B (Informative) Measurement instruments Annex C (Informative) Measurement methods for radiance/irradiance Annex D (Informative) Guidance on the direct measurement of irradiance Annex E (Informative) Examples of measurement methods for specific ophthalmic instruments Annex F (Informative) Safety signs Bibliography