IEC 60601-2-25:2011
医疗电气设备.第2-25部分:心电描记器基本安全性和基本性能的特殊要求
Medical electrical equipment - Part 2-25: Particular requirements for basic safety and essential performance of electrocardiographs
IEC 60601-2-25:2011 发布历史
IEC 60601-2-25:2011由国际电工委员会 IX-IEC 发布于 2011-10，并于 2011-10-21 实施。
IEC 60601-2-25:2011 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,11.040.99 其他医疗设备。
本标准有修改采用的 中文版 GB 9706.225-2021 医用电气设备 第2-25部分：心电图机的基本安全和基本性能专用要求
IEC 60601-2-25:2011的历代版本如下：
- 2011年 IEC 60601-2-25:2011 医疗电气设备.第2-25部分:心电描记器基本安全性和基本性能的特殊要求
- 1999年 IEC 60601-2-25/AMD1:1999 医用电气设备 第2-25部分:心电图机安全专用要求 修改1
- 1993年 IEC 60601-2-25:1993 医用电气设备 第2-25部分:心电图机安全专用要求
Replacement: This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROCARDIOGRAPHS as defined in 201.3.63 intended by themselves or as a part of an ME SYSTEM@ for the production of ECG REPORTS for diagnostic purposes@ hereinafter referred to as ME EQUIPMENT. Not included within the scope of this particular standard are: a) the part of ME EQUIPMENT that provides vectorcardiographic loops; b) ambulatory electrocardiographic ME EQUIPMENT covered by IEC 60601-2-47 where not intended for obtaining ECG REPORTS for diagnostic purposes; c) cardiac monitors covered by IEC 60601-2-27 where not intended for obtaining ECG REPORTS for diagnostic purposes. NOTE 1 For example. ME EQUIPMENT includes: a) direct-writing ELECTROCARDIOGRAPHS; b) other ME EQUIPMENT that produce ECG REPORTS for diagnostic purposes@ e.g. patient monitors@ defibrillators@ exercise testing devices; c) ELECTROCARDIOGRAPHS having a display that is remote from the PATIENT (e.g. via phone lines@ networks or storage media). These ME EQUIPMENT or ME SYSTEMS are within the scope of this particular standard excluding transmission media. NOTE 2 ME EQUIPMENT that provide selection between diagnostic and monitoring functions shall meet the requirements of the appropriate standard when configured for that function. ME EQUIPMENT intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician's office@ 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.
- 标准号
- IEC 60601-2-25:2011
- 发布
- 2011年
- 中文版
- GB 9706.225-2021 (修改采用的中文版本)
- 发布单位
- 国际电工委员会
- 当前最新
- IEC 60601-2-25:2011
- 被代替标准
- IEC 62D/944/FDIS:2011 IEC 60601-2-25:1993 IEC 60601-2-25 AMD 1:1999 IEC 60601-2-51:2005