[Title 21 CFR 898]
[Code of Federal Regulations (annual edition) - April 1, 1999 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION,]
[Subchapter H - MEDICAL DEVICES]
[Part 898 - PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES]
[From the U.S. Government Printing Office]
21FOOD AND DRUGS81999-04-011999-04-01falsePERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES898PART 898FOOD AND DRUGSFOOD AND DRUG ADMINISTRATION,MEDICAL DEVICES
PART 898--PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES--Table of Contents
Sec.
898.11 Applicability.
898.12 Performance standard.
898.13 Compliance dates.
898.14 Exemptions and variances.
Authority: 21 U.S.C. 351, 352, 360c, 360d, 360gg-360ss, 371, 374; 42
U.S.C. 262, 264.
Source: 62 FR 25497, May 9, 1997, unless otherwise noted.
Sec. 898.11 Applicability.
Electrode lead wires and patient cables intended for use with a
medical device shall be subject to the performance standard set forth in
Sec. 898.12.
Sec. 898.12 Performance standard.
(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.
Sec. 898.13 Compliance dates.
The dates for compliance with the standard set forth in
Sec. 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
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21 CFR
Phase Product code section Class Device name
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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.
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(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.
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Sec. 898.14 Exemptions and variances.
(a) A request for an exemption or variance shall be submitted in the
form of a petition under Sec. 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 Sec. 10.30(e)(2)(i) of this chapter.
Effective Date Note: At 62 FR 25477, May 9, 1997, Sec. 898.14 was
stayed pending Office of Management and Budget clearance for information
collection.
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