标准编号：ISO 15004-2:2007
中文名称：眼科手术器械 基本要求和试验方法 第2部分：光危害防护
英文名称：Ophthalmic instruments — Fundamental requirements and test methods — Part 2: Light hazard protection
发布日期：2007-02
标准范围
This part of ISO 15004 specifies fundamental requirements for optical radiation safety for ophthalmicinstruments and is applicable to all ophthalmic instruments that direct optical radiation into or at the eye andfor which there is a specific light hazards requirement section within their respective International Standards,i.e. all ophthalmic instruments listed in Annex B. It is also applicable to all new and emerging ophthalmicinstruments that direct optical radiation into or at the eye. Where differences exist between this part ofISO 15004 and the light hazard requirements section of the respective vertical International Standard, then thevertical International Standard shall take precedence.This part of ISO 15004 does not apply to radiation that is in excess of limits specified in ISO 15004 and that isintended for treatment of the eye.This part of ISO 15004 classifies ophthalmic instruments into either Group 1 or Group 2 in order to distinguishinstruments that are non-hazardous from those that are potentially hazardous.
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