(b) An active diagnostic medical device referred to in sub-clause (1) of clause (a) shall be assigned to Class A, if it is intended to be used solely to illuminate a patient's body with light in the visible or near infrared spectrum. (c) An active diagnostic medical device referred to in clause (a) shall be assigned to Class C, if it is intended specifically for, — (1) the monitoring of vital physiological parameters, where the nature of any variation is such that it could result in immediate danger to the patient (such as any variation in cardiac performance, respiration or activity of the central nervous system); or (2) diagnosing in a clinical situation where the patient is in immediate danger. (d) An active diagnostic medical device shall be assigned to Class C, if it is intended for the emission of ionising radiation and to be used in diagnostic or interventional radiology
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