标准编号：ISO 15004-1:2020
中文名称：眼科设备 基本要求和试验方法 第1部分：眼科器械通用要求
英文名称：Ophthalmic instruments — Fundamental requirements and test methods — Part 1: General requirements applicable to all ophthalmic instruments
发布日期：2020-05
标准范围
This document specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments and to devices for enhancing low vision. This document is also applicable to tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye.
This document is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.
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