(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 EffectiveMay 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.
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