IEC 60601-2-25:2011
Medical electrical equipment - Part 2-25: Particular requirements for basic safety and essential performance of electrocardiographs

Standard No.

IEC 60601-2-25:2011

Release Date

2011

Published By

International Electrotechnical Commission (IEC)

Latest

IEC 60601-2-25:2011

Replace

IEC 62D/944/FDIS:2011 IEC 60601-2-25:1993 IEC 60601-2-25 AMD 1:1999 IEC 60601-2-51:2005

Scope

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.

IEC 60601-2-25:2011 history

• 2011 IEC 60601-2-25:2011 Medical electrical equipment - Part 2-25: Particular requirements for basic safety and essential performance of electrocardiographs
• 1970 IEC 60601-2-25:1993/AMD1:1999 Amendment 1 - Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs
• 1993 IEC 60601-2-25:1993 Medical electrical equipment; part 2: particular requirements for the safety of electrocardiographs