ISO 15004-1:2020 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

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

本文件规定了非侵入式、主动式和非主动式眼科仪器以及增强低视力设备的基本要求。本文件也适用于眼压计，但不适用于与眼球接触的其他眼科仪器。本文件不适用于用于眼睛激光检查或激光治疗的手术显微镜、内窥镜和设备。

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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