|Recognition List Number: 023 FR Publication Date: 05/05/2010
Part B: Supplementary Information
Recognition Number 3-72: AAMI / ANSI EC53:1995/(R) 2008, ecg cables and leadwires. (Cardiovascular)
Date of Standard: 2008.
|Addresses of Standards Development Organizations:|
| Association for the Advancement of Medical Instrumentation (AAMI)|
| 4301 North Fairfax Drive|
| Suite 301|
| Arlington, VA 22203 |
| American National Standards Institute (ANSI)|
| 25 West 43rd Street|
| 4th Floor|
| New York, NY 10036 |
|CDRH Office and Division associated with recognized standards:|
|OFFICE OF DEVICE EVALUATION (ODE) |
|DIVISION OF CARDIOVASCULAR DEVICES (DCD) |
|Electrode Leadwires and Patient Cables intended for use with the following devices: Electrocardiographs (ECGS),
Cardiac Monitors, Arrhythmia Detectors and Alarms, DC Defibrillators, Multiparameter Physiological Monitors, Breathing Frequency Monitors, Ventilatory Effort Monitors (Apnea Detectors), Other devices that use patient cables
|Processes Affected: |
|510(k), PMA, IDE, PDP, HDE|
|Type of Standard:|
| National, Horizontal|
|Extent of Recognition:|
|Complete Standard (including proposed changes, January 1998).
NOTE: This standard covers cables and patient leadwires used for surface electrocardiographic (ECG) monitoring in cardiac monitors as defined in ANSI/AAMI EC13-1992, Cardiac monitors, heart rate meters, and alarms. It covers both disposable and reusable leadwires, with certain sections applicable to both, and certain sections applicable only to one.
This standard defines a safe (no exposed metal pins) common interface at the cable yoke and leadwire connector. Specified in the standard are the following: Labeling requirements; Construction requirements; Cleaning disinfection and chemical resistance requirements; Sterilization exposure requirements; and Performance requirements (trunk cable and patient leadwires). The parameters specifically addressed by the performance requirements include the following: Dielectric withstand voltage; Sink current; Defibrillation withstand; Cable and leadwire noise; Flex life of instrument connector, cable yoke, patient leadwire connector, and patient end termination flex relief; Tensile strength of cable connections; Number of connector mate/unmate cycles; Contact resistance; Connector retention force and Patient leadwire resistance.
1. This standard also incorporates by reference the DIN 42-802 standard (Connector, touch proof, for electromedical application, 1990).
2. Devices that comply with this standard also meet the FDA mandatory standard 21 CFR Part 898, "Medical Devices; Establishment of a Performance Standard for Electrode Lead Wires and Patient Cables."
3. Exclusions: The scope of EC53 excludes ECG cables and leadwires that are used in applications that may require special characteristics, such as ambulatory ECG devices, telemetry units, the operating room and the cardiac catheterization lab. The cables and patient leadwires included in the scope of EC53 may supply other functions in addition to ECG monitoring, such as respiration monitoring by impedance pneumography. In this case, the cable and patient leadwires should meet all of the requirements of this standard, unless a requirement is specifically excluded for that device by the standard.
Caution: A device manufacturer who claims to meet subclause 1.2 (Exclusions) of EC53 does not attest compliance to EC53.
|Related CFR Citations and Product Codes:|
||Monitor, Breathing Frequency
||Monitor, Apnea, Facility Use
||Detector And Alarm, Arrhythmia
||Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
||Dc-Defibrillator, Low-Energy, (Including Paddles)
||Automated External Defibrillators (Non-Wearable)
|FDA Technical Contacts:|
| Shawn Forrest |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1244 |
| Silver Spring MD 20993 |
| 301/796-5554 |
| email: email@example.com|