IEC 60601-2-27:2011/COR1:2012
医用电气设备.第2-27部分:心电监护设备基本安全性和必要性能的详细要求
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment; Corrigendum 1
IEC 60601-2-27:2011/COR1:2012 发布历史
"Replacement: This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT as defined in 201.3.63 and hereinafter also referred to as ME EQUIPMENT. This particular standard applies to ME EQUIPMENT used in a hospital environment as well as when used outside the hospital environment@ such as in ambulances and air transport. This particular standard also applies to ECG telemetry systems used in a hospital environment. ME EQUIPMENT intended for use under extreme or uncontrolled environmental conditions outside the hospital environment@ such as in ambulances and air transport@ shall comply with this particular standard. Additional standards may apply to ME EQUIPMENT for those environments of use. This standard is not applicable to electrocardiographic monitors for home use. However@ MANUFACTURERS should consider using relevant clauses of this standard as appropriate for their INTENDED USE. Ambulatory (""Holter"") monitors@ fetal heart rate monitoring@ pulse plethysmographic devices@ and other ECG recording equipment are outside the scope of this particular standard."
IEC 60601-2-27:2011/COR1:2012由国际电工委员会 IX-IEC 发布于 2012-05，并于 2012-05-31 实施。
IEC 60601-2-27:2011/COR1:2012 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 60601-2-27:2011/COR1:2012的历代版本如下：
- 2012年 IEC 60601-2-27:2011/COR1:2012 医用电气设备.第2-27部分:心电监护设备基本安全性和必要性能的详细要求
- 2011年 IEC 60601-2-27:2011 医用电气设备.第2-27部分:心电图监护设备的基本安全性和必要性能用详细要求
- 2005年 IEC 60601-2-27:2005 医用电气设备.第2-27部分:心电图监护设备安全专用要求(包含基本性能)
- 1994年 IEC 60601-2-27:1994 医用电气设备 第2-27部分:心电图监护设备安全专用要求
- 标准号
- IEC 60601-2-27:2011/COR1:2012
- 发布
- 2012年
- 发布单位
- 国际电工委员会
- 当前最新
- IEC 60601-2-27:2011/COR1:2012
- 适用范围
- "Replacement: This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT as defined in 201.3.63 and hereinafter also referred to as ME EQUIPMENT. This particular standard applies to ME EQUIPMENT used in a hospital environment as well as when used outside the hospital environment@ such as in ambulances and air transport. This particular standard also applies to ECG telemetry systems used in a hospital environment. ME EQUIPMENT intended for use under extreme or uncontrolled environmental conditions outside the hospital environment@ such as in ambulances and air transport@ shall comply with this particular standard. Additional standards may apply to ME EQUIPMENT for those environments of use. This standard is not applicable to electrocardiographic monitors for home use. However@ MANUFACTURERS should consider using relevant clauses of this standard as appropriate for their INTENDED USE. Ambulatory (""Holter"") monitors@ fetal heart rate monitoring@ pulse plethysmographic devices@ and other ECG recording equipment are outside the scope of this particular standard."