| IEC 60601-2-27 Edition 3.0 2011-03 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)] |
| Recognition Number | Cardiovascular |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 3-126 |
| Extent | Complete standard |
| Standards Orgs | IEC International Electrotechnical Commission http://www.iec.ch/ |
| STG | Cardiovascular |
| FDA Tech | Shawn Forrest FDA/OMPT/CDRH/ODE/DCD/CDDB/ 301-796-5554 shawn.forrest@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This standard specifies basic safety requirements and essential performance for electrocardiographic (ECG) monitoring equipment. It is applicable to ECG monitoring equipment used in a hospital environment. If it is used outside the hospital environment, such as in ambulances and air transport, the ECG monitoring equipment shall comply with this standard. This standard is not applicable to electrocardiographic monitors for home use and ECG telemetry systems. However, manufacturers should consider using relevant clauses of this standard as appropriate for their intended use/intended purpose. Ambulatory ("Holter") monitors, fetal heart rate monitors, pulse plethysmographic devices, and other ECG recording equipment are outside the scope of this particular standard.
| Regulation Number | Device Name | Device Class | Product Code |
| §870.2340 | Electrocardiograph | Class 2 | DPS |
| AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012,, c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (iec 60601-1:2005, mod). |