标准摘要
[中文适用范围]: 补充:本专用标准规定了 2.101 中定义的经皮局部压力监测设备的安全要求,包括基本性能,以下简称设备,无论该设备是独立的还是系统的一部分。它适用于成人、儿童和新生儿使用的经皮监护仪,并包括这些设备在出生期间胎儿监护中的使用。它不适用于血红蛋白饱和血氧计或应用于皮肤以外的身体表面(例如结膜、粘膜)的设备。 [外文原描述]: Specifies requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment, whether this equipment is stand alone or part of a system. Applies to transcutaneous monitors used with adults, children and neonates, and it includes the use of these devices in foetal monitoring during birth.
英文名称Medical electrical equipment - Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment