Guidance Document on the Performance Standard for Electrode Lead Wires and Patient Cables | Regulatory Doctor
The Performance Standard for Electrode Lead Wires and Patient Cables, found in Title 21 Code of Federal Regulations (CFR), part 898, was published in the Federal Register on May 9, 1997 [62 FR 25497]. The performance standard becomes effective for certain devices on May 11, 1998.
§ 898.11 – Applicability.
§ 898.12 – Performance standard.
§ 898.13 – Compliance dates.
§ 898.14 – Exemptions and variances.
This guidance document represents the agency’s initial thinking on implementation of the performance standard for electrode lead wires and patient cables. This guidance does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the applicable statute, regulations, or both. Due to the public health risks associated with the use of unprotected electrode lead wires and patient cables, the agency is accepting public input while the guidance is being implemented.
The performance standard was promulgated to address the electrocution hazard posed by unprotected patient electrical connectors. Copies of the final rule are also available through the Division of Small Manufacturers Assistance via Facts-on-Demand at 800-899-0381, or 301-827-0111.
This is the first mandatory medical device performance standard, and it is being implemented in two phases. Beginning on May 11, 1998, all electrode lead wires or patient cables intended for use with any of the following devices must comply with the standard:
- Breathing Frequency Monitors
- Ventilatory Effort Monitors (Apnea Detectors)
- Electrocardiographs (ECGs)
- Radio Frequency Physiological Signal Transmitters and Receivers
- Cardiac Monitors
- Electrocardiograph Electrodes (including Pre-wired ECG Electrodes)
- Patient Transducer and Electrode Cables (including Connectors)
- Medical Magnetic Tape Recorders (e.g., Holter Monitors)
- Arrhythmia Detectors and Alarms
- Telephone Electrocardiograph Transmitters and Receivers