Electrode lead wires and patient cables intended for use with a medical device shall be subject to the performance standard set forth in § 898.12.
(a) Any connector in a cable or electrode lead wire having a conductive connection to a patient shall be constructed in such a manner as to comply with subclause 56.3(c) of the following standard:
International Electrotechnical Commission (IEC)
601-1: Medical Electrical Equipment
601-1 (1988) Part 1: General requirements for safety
Amendment No. 1 (1991)
Amendment No. 2 (1995).
(b) Compliance with the standard shall be determined by inspection and by applying the test requirements and test methods of subclause 56.3(c) of the standard set forth in paragraph (a) of this section.
The dates for compliance with the standard set forth in § 898.12(a) shall be as follows:
(a) For electrode lead wires and patient cables used with, or intended for use with, the following devices, the date for which compliance is required is May 11, 1998:
Listing of Devices for Which Compliance is Required Effective
May 11, 1998
| Phase
| Product code
| 21 CFR section
| Class
| Device name
|
|---|
| 1 | 73 BZQ | 868.2375 | II | Monitor, Breathing Frequency.
|
| 1 | 73 FLS | 868.2375 | II | Monitor (Apnea Detector), Ventilatory Effort.
|
| 1 | 74 DPS | 870.2340 | II | Electrocardiograph.
|
| 1 | 74 DRG | 870.2910 | II | Transmitters and Receivers, Physiological Signal, Radio Frequency.
|
| 1 | 74 DRT | 870.2300 | II | Monitor, Cardiac (including Cardiotachometer and Rate Alarm).
|
| 1 | 74 DRX | 870.2360 | II | Electrode, Electrocardiograph.
|
| 1 | 74 DSA | 870.2900 | II | Cable, Transducer and Electrode, Patient (including Connector).
|
| 1 | 74 DSH | 870.2800 | II | Recorder, Magnetic Tape, Medical.
|
| 1 | 74 DSI | 870.1025 | III | Detector and Alarm, Arrhythmia.
|
| 1 | 74 DXH | 870.2920 | II | Transmitters and Receivers, Electrocardiograph, Telephone. |
(b) For electrode lead wires and patient cables used with, or intended for use with, any other device, the date for which compliance is required is May 9, 2000.
(a) A request for an exemption or variance shall be submitted in the form of a petition under § 10.30 of this chapter and shall comply with the requirements set out therein. The petition shall also contain the following:
(1) The name of the device, the class in which the device has been classified, and representative labeling showing the intended uses(s) of the device;
(2) The reasons why compliance with the performance standard is unnecessary or unfeasible;
(3) A complete description of alternative steps that are available, or that the petitioner has already taken, to ensure that a patient will not be inadvertently connected to hazardous voltages via an unprotected patient cable or electrode lead wire for intended use with the device; and
(4) Other information justifying the exemption or variance.
(b) An exemption or variance is not effective until the agency approves the request under § 10.30(e)(2)(i) of this chapter.
Effective Date Note:At 62 FR 25477, May 9, 1997, § 898.14 was stayed pending Office of Management and Budget approval of information collection and recordkeeping requirements.