IEC 80601-2-60:2019 医疗电气设备 - 第2-60部分:牙科设备的基本安全和基本性能的特殊要求

标准编号：IEC 80601-2-60:2019

中文名称：医疗电气设备 - 第2-60部分:牙科设备的基本安全和基本性能的特殊要求

英文名称：Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment

发布日期：2019-06-27

标准范围

IEC 80601-2-60:2019适用于牙科设备、牙科病人椅、牙科手机和牙科手术灯（以下简称牙科设备）的基本安全和基本性能。如果一个条款或子条款特别旨在仅适用于ME设备，或仅适用于ME系统，该条款或子条款的标题和内容将如此说明。如果不是这种情况，该条款或子条款适用于相关的ME设备和ME系统。本文件范围内的医用电气设备或医用电气系统预期生理功能中固有的危害，除通用标准的7.2.13和8.4.1外，本文件的具体要求未涵盖。IEC 80601-2-60:2019取消并取代2012年发布的第一版。本版构成技术修订版。与上一版相比，此版本包括以下重大技术变更:a)符合IEC 60601-1:20 05和IEC 60601-1:20 05/AMD1:2012。

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.

标准预览图