scope:

These requirements cover electric medical and dental equipment that is intended for professional use by personnel in hospitals, nursing homes, medical care centers, medical and dental offices and similar Health Care Facilities including apparatus intended to be used with oxygen-administering equipment. The equipment covered is for use on interior wiring systems in accordance with the National Electrical Code. These requirements cover portable (cord-connected) equipment rated at 300 V or less and permanently connected equipment rated at 600 V or less.

The Standard also covers general requirements for equipment batteries, and battery-operated products that are energized by a battery supply having a voltage of 300 V dc or less, or battery power and provisions for connection to branch circuits rated 300 V or less in accordance with

the National Electrical Code.

These requirements do not cover electrically heated pads, refrigerated

medical equipment, X-ray equipment, hospital food warming cabinets and carts, nurse call and intercommunication equipment, isolated power systems, nor other equipment or appliances that are covered by separate individual requirements.

These requirements do not cover equipment for use in hazardous locations (with respect to flammable anesthetics), as defined in the National Electrical Code, ANSI/NFPA No. 70. Equipment intended for hospital operating room use above the hazardous area is judged under the requirements of this standard and in accordance with National Electrical Code, ANSI/NFPA No. 70.

The requirements in 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 appropriate warnings prominently

displayed on the device (see 71.1).

A product that contains features, characteristics, components,

materials, or systems new or different from those covered by the requirements in this Standard, 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 to determine that the level of safety as originally anticipated by the intent of this Standard is maintained. A product whose features, characteristics, components, materials, or systems conflict with specific requirements or provisions of this Standard shall not be judged to comply with this Standard. Where appropriate, revision of requirements shall be proposed and adopted in conformance with the methods employed for development, revision, and implementation of this Standard.

1.6 added December 30, 1998