CAN-CSA C22-2 NO 60601-1-14 Medical Electrical Equipment - General Requirements for Basic Safety and Basic Performance

This International Standard applies to the essential safety and essential performance of medical electrical equipment and medical electrical systems, hereinafter referred to as ME equipment and ME systems. If an article or subclause is specifically intended to apply to ME equipment only or ME systems only, the title and content of that article or subclause shall indicate so. If this is not the case, the item or subclause applies to both ME equipment and related ME systems.

Hazards inherent in the intended physiological function of ME equipment or ME systems under this standard are not covered by the specific requirements of this standard, except 7.2.13 and 8.4.1. This Standard is also applicable to equipment used for the compensation or alleviation of diseases. Injury or disability. In vitro diagnostic equipment that does not fall within the definition of ME equipment is covered by IEC 61010 series 2. This Standard does not apply to the implantable parts of active implantable medical devices within the scope of ISO 14708-1-3. The purpose of this standard is to specify general requirements and to form the basis for specific standards.

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