Page 31 - Safety Risk Management for Medical Devices

10 Safety Risk Management for Medical Devices

Table 3.1 (Continued)
Term Definition

Fault an anomalous condition for a part
Harm injury or damage to the health of people, or damage to property or
the environment [1]
Hazard potential source of harm [1]
Hazardous Situation circumstance in which people, property, or the environment are
exposed to one or more hazards [1]
Instruction for Use information provided by the manufacturer to inform the user of
the device’s intended purpose and proper use and of any
precautions to be taken [2] article 2, (14)
Intended Use use for which a product, process or service is intended according to
the specifications, instructions and information provided by the
manufacturer [3]
Intended purpose use for which a device is intended according to the data supplied
by the manufacturer on the label, in the instructions for use or
in promotional or sales materials or statements and as specified
by the manufacturer in the clinical evaluation [2] Article 2 (12)
Label written, printed or graphic information appearing either on the
device itself, or on the packaging of each unit or on the
packaging of multiple devices [2] Article 2 (13)
Residual Risk risk remaining after risk reduction measures have been
implemented [1]
including actions to avoid, or limit the harm
Risk combination of the probability of occurrence of harm and the
severity of that harm [2] article 2, (23)
Risk Analysis systematic use of available information to identify hazards and to
estimate the risk [1]
Risk Assessment overall process comprising a risk analysis and a risk evaluation [1]
Risk Control process in which decisions are made and measures implemented by
which risks are reduced to, or maintained within, specified levels [3]

Risk Estimation process used to assign values to the probability of occurrence of
harm and the severity of that harm [3]
Risk Evaluation process of the estimated risk against given risk criteria to determine
the acceptability of the risk [3]
Risk Management systematic application of management policies, procedures and
practices to the tasks of analyzing, evaluating, controlling and
monitoring risk [3]
Risk Management set of records and other documents that are produced by risk
File management [3]
Safety freedom from unacceptable risk [3]

(Continued)