CAN/CSA-C22.2 NO. 60601-2-25:12:2012 Edition

Preface

This is the second edition of CAN/CSA-C22.2 No. 60601-2-25, Medical electrical equipment – Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-25 (second edition, 2011-10). It supersedes the previous edition, published in 1994 as CAN/CSA-C22.2 No. 601.2.25 under the title Medical electrical equipment – Part 2: Particular requirements for the safety of electrocardiographs (adopted IEC 601-2-25:1993). It also replaces CAN/CSA-C22.2 No. 60601-2-51, published in 2004 under the title Medical electrical equipment – Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs (adopted IEC 60601-2-51:2003; replaced by IEC bilingual edition, 2005). It is one in a series of Standards issued by CSA under Part II of the Canadian Electrical Code.

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.None