| ANSI AAMI EC53:2013 ECG trunk cables and patient leadwires |
| Recognition Date | 2014-07-09 |
| Recognition List | 036 |
| Recognition Number | 3-129 |
| Extent | Complete standard |
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| STG | Cardiovascular |
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The objective of this standard is to allow ECG TRUNK CABLES and PATIENT LEADWIRES to be interchanged between ECG DEVICES with isolated PATIENT connections by establishing a common interface between the TRUNK CABLE and the PATIENT LEADWIRE connectors. Performance and safety criteria for TRUNK CABLES and PATIENT LEADWIRES used with isolated PATIENT connectors are also specified. This standard's original scope related to TRUNK CABLES and PATIENT LEADWIRES used with cardiac monitors. The scope was extended to include PATIENT LEADWIRES used with other ECG DEVICES including diagnostic electrocardiographs, ambulatory ECG (Holter) recorders/event recorders and ECG telemetry.
| Regulation Number | Device Name | Device Class | Product Code |
| §878.4040 | Respirator, Surgical | Class 2 | MSH |
| §870.5310 | Automated External Defibrillators (Non-Wearable) | Class 3 | MKJ |
| §870.5310 | Over-The-Counter Automated External Defibrillator | Class 3 | NSA |
| §870.5300 | Atrial Defibrillator | Class 3 | MPC |
| §870.5300 | Dc-Defibrillator, High Energy, (Including Paddles) | Class 3 | DRK |
| §870.5300 | Dc-Defibrillator, Low-Energy, (Including Paddles) | Class 2 | LDD |
| §870.2910 | Transmitters And Receivers, Physiological Signal, Radiofrequency | Class 2 | DRG |
| §870.2800 | Electrocardiograph, Ambulatory (Without Analysis) | Class 2 | MWJ |
| §870.2800 | Electrocardiograph, Ambulatory, With Analysis Algorithm | Class 2 | MLO |
| §870.2800 | Recorder, Magnetic Tape, Medical | Class 2 | DSH |
| §870.2340 | Electrocardiograph | Class 2 | DPS |
| §870.2340 | Monitor, St Segment | Class 2 | MLC |
| §870.2340 | Single Lead Over-The-Counter Electrocardiograph | Class 2 | OEY |
| §870.2300 | Low Patient Acuity Monitoring System | Class 2 | PFY |
| §870.2300 | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Class 2 | DRT |
| §870.2300 | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Class 2 | MWI |
| §870.1025 | Detector And Alarm, Arrhythmia | Class 2 | DSI |
| §870.1025 | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Class 2 | MHX |
| §870.1025 | Monitor, St Segment With Alarm | Class 2 | MLD |
| §868.2377 | Monitor, Apnea, Facility Use | Class 2 | FLS |
| §868.2375 | Monitor, Breathing Frequency | Class 2 | BZQ |
| §868.2377 | Monitor, Apnea, Facility Use | Class 2 | FLS |
| There is no relevant guidance developed at this time. |