标准号:BS EN ISO 15004-1-2009
中文标准名称:眼科器械.基本测试方法和要求.第1部分:适用于所有眼科器械的一般要求(ISO 15004-1-2006)
英文标准名称:Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements
applicable to all ophthalmic instruments (ISO 15004-1:2006)
标准类型:C32
发布日期:2009/7/31 12:00:00
实施日期:2009/7/31 12:00:00
中国标准分类号:C32
国际标准分类号:11.040.70
引用标准:ISO 9022-2-2002;ISO 9022-3-1998;ISO 15004-2;IEC 60601-1-2005;IEC 60601-1-1-1992;IEC 60695-2-10-2000;IEC 60695-2-11-2000
适用范围:This part of ISO 15004 specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments. This part of ISO 15004 is also applicable to low-vision aids and tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye.This part of ISO 15004 is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.