|Edition Number:||4||SCC Approved:||--|
|Edition Date:||1993-08-30||DOD Approved:||--|
|Price Code:||B||ANSI Approved:||--|
1.1 These requirements cover refrigerated medical equipment such as thermia and oxygen therapy devices for use in hospitals, nursing homes, medical care centers, medical and dental offices, and similar health care facilities in accordance with the National Electric Code, NFPA 70.
1.2 Equipment covered by these requirements employ hermetic refrigerant motor-compressors and air- or water-cooled condensers, designed for use on alternating current circuits rated not more than 600 volts. These requirements take into consideration the hazards resulting from the presence of oxygen and the intended use of oxygen administering equipment but do not cover the canopy (tent), or oxygen storage and distribution systems with which the equipment may be used.
1.3 These requirements do not cover equipment for use in hazardous locations, with respect to flammable anesthetics, as defined in the National Electrical Code, NFPA 70.
1.4 The requirements of this Standard do not consider the complete spectrum of physiological or therapeutic effects, beneficial or otherwise, except where generally accepted limits for potentially hazardous conditions are defined. Devices which necessitate the utilization of conditions exceeding such accepted limits for patient treatment are intended for use by or under the supervision of licensed medical persons. Such equipment shall be provided with warnings prominently displayed on the device.
1.5 A product that contains features, characteristics, components, materials, or systems new or different from those in use when the standard was developed, and that involves a risk of fire, electric shock, or injury to persons shall be evaluated using the appropriate additional component and end-product requirements as determined necessary to maintain the level of safety for the user of the product as originally anticipated by the intent of this standard.