IEC 60601-2-23:2011
医用电气设备.第2-23部分:经皮分压监护设备的基本安全性和必要性能的详细要求

Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment

IEC 60601-2-23:2011 发布历史

IEC 60601-2-23:2011由国际电工委员会 IX-IEC 发布于 2011-02，并于 2011-03-04 实施。

IEC 60601-2-23:2011 在中国标准分类中归属于: C39 医用电子仪器设备，在国际标准分类中归属于: 11.040.55 诊断设备。

IEC 60601-2-23:2011的历代版本如下：

• 2011年 IEC 60601-2-23:2011 医用电气设备.第2-23部分:经皮分压监护设备的基本安全性和必要性能的详细要求
• 1999年 IEC 60601-2-23:1999 医用电气设备 第2-23部分:经皮分压监护设备 安全专用要求
• 1993年 IEC 60601-2-23:1993 医疗电气设备.第2部分第23节:经皮分压监测设备的安全专用要求

Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT as defined in 201.3.63 and hereinafter referred to as ME EQUIPMENT@ whether this ME EQUIPMENT is stand alone or part of a system. This standard applies to transcutaneous monitors used with adults@ children and neonates@ and it includes the use of these devices in foetal monitoring during birth. This standard does not apply to haemoglobin saturation oximeters or to devices applied to surfaces of the body other than the skin (for example conjunctiva@ mucosa). 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 standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the General Standard.

标准号

IEC 60601-2-23:2011

发布

2011年

发布单位

国际电工委员会

当前最新

IEC 60601-2-23:2011

 

 

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