Documents and information for the responsible organization or operator regarding the medical electrical equipment,
particularly about basic safety and essential performance
Active therapeutic device
The operation of the device depends on an electrical energy source, and is used for the treatment or alleviation of
injuries and diseases
The part of the medical electrical equipment that in normal use comes into physical contact with the patient during
treatment
Freedom from unacceptable risks directly caused by physical hazards when the medical electrical equipment is
used under normal conditions and in single fault condition
Performance necessary to achieve freedom from unacceptable risks
Term referring to electrical equipment that is intended to be managed by hand in normal use
Potential source of harm (harm is defined as physical injury or damage to the health of people or animals, as well as
damage to property or the environment)
Use of a product, process or service in accordance with the specifications, instructions and information provided by
the manufacturer
Term referring to electrical equipment that is able to operate by means of an internal electrical power source
Condition in which all provided means to prevent hazards are intact
Operation and use, including routine inspections and adjustments, in accordance with the instruction manual
Person handling the equipment
Person undergoing treatment
Entity accountable for the use and maintenance of a medical electrical equipment or system. For example, a
hospital, an individual clinician or a layperson. For domestic use, the patient, operator and responsible organization
can be one and the same person
Combination of the degree or probability of harm and the severity of the harm caused
Persons accountable to the responsible organization for installing, assembling, maintaining, and repairing the
medical electrical equipment
An instrument that can be used manually to secure or release fasteners/screws or to make adjustments
Normally intended for less than 60 minutes of continuous use
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