ISO 15004-2:2007 眼科手术器械 基本要求和试验方法 第2部分：光危害防护

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

ISO 15004-2:2007规定了眼科仪器光学辐射安全的基本要求，适用于所有将光学辐射导入或照射眼睛的眼科仪器，并且在其各自的国际标准中有特定的光危害要求部分。它也适用于所有新的和新兴的眼科仪器，这些仪器将光辐射导入或照射眼睛。ISO 15004-2:2007不适用于超过ISO 15004规定限值且用于眼部治疗的辐射。ISO 15004-2:2007将眼科仪器分为第1组或第2组，以区分非危险仪器和潜在危险仪器。

ISO 15004-2:2007 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 and for which there is a specific light hazards requirement section within their respective International Standards. It is also applicable to all new and emerging ophthalmic instruments that direct optical radiation into or at the eye.ISO 15004-2:2007 does not apply to radiation that is in excess of limits specified in ISO 15004 and that is intended for treatment of the eye.ISO 15004-2:2007 classifies ophthalmic instruments into either Group 1 or a Group 2 in order to distinguish instruments that are non-hazardous from those that are potentially hazardous.

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