標準號：BS EN ISO 15004-1-2009
中文標準名稱：眼科器械.基本測試方法和要求.第1部分:適用于所有眼科器械的一般要求(ISO 15004-1-2006)
英文標準名稱：Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006)
標準類型：C32
發布日期：2009/7/31 12:00:00
實施日期：2009/7/31 12:00:00
中國標準分類號：C32
國際標準分類號：11.040.70
引用標準：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
適用范圍：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.