ISO 14971 - Key Terms and definitions Questions & Answers
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ISO 14971 - Key Terms and definitions Questions & Answers
Scope of term 'RISK' wrt ISO 14971
When the term "risk" is used, the application of the term within the scope of this International
Standard pertains to safety or performance requirements of the medical device or meeting
applicable regul...
ISO 14971 - Key Terms and definitions
Questions & Answers
Scope of term 'RISK' wrt ISO 14971 - answer When the term "risk" is used, the
application of the term within the scope of this International
Standard pertains to safety or performance requirements of the medical device or
meeting
applicable regulatory requirements.
risk - answer combination of the probability of occurrence of harm and the severity of
that harm
harm - answer injury or damage to the health
of people, or damage to property or the
environment
hazard - answer potential source of harm
hazardous situation - answer circumstance in which people, property,
or the environment are exposed to one
or more hazard(s)
life-cycle - answer all phases in the life of a medical device,
from the initial conception to final
decommissioning and disposal
objective evidence - answer data supporting the existence or verity
of something
post-production - answer part of the life-cycle of the product after
the design has been completed and the
medical device has been manufactured
residual risk - answer risk remaining after risk control
measures have been taken
risk analysis - answer systematic use of available information
to identify hazards and to estimate the
risk
risk assessment - answer overall process comprising a risk
analysis and a risk evaluation
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