标准摘要
[中文适用范围]: 本IEC 80601标准适用于牙科患者椅、牙科手机和牙科手术灯的基本安全和基本性能,以下统称为牙科设备。牙科单元。如果条款或子条款专门旨在适用于医用电气设备或医用系统,则该条款或子条款的标题和内容将说明这一点。如果没有这种情况,则该条款或子条款适用于医用设备和医用系统(如适用)。本文件范围内医用设备或医用系统旨在生理功能内固有的危害,在本文件中没有具体要求的,除非在通用标准7.2.13和8.4.1中另有说明。 [外文原描述]: IEC 80601-2-60:2019 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE OF DENTAL UNITS, DENTAL PATIENT CHAIRS, DENTAL HANDPIECES AND DENTAL OPERATING LIGHTS, hereafter referred to as DENTAL EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. IEC 80601-2-60:2019 cancels and replaces the first edition published in 2012. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) alignment with IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.
英文名称Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment