Evaluation (Validation and Verification) - Medical Device Design: Innovation from Concept to Market - page 206

Table 9.2: Examples of Hazards Table 9.2: (Continued)

Examples of Energy
Hazards

Examples of Biological
and Chemical Hazards

Examples of
Operational Hazards

Examples of Information
Hazards

Thermal energy
Ductile-brittle
transition?
Burning/scalding?
Radiated, conductive,
or convective heat?
Freezing?
Will it act as a heat
sink?
Will it excessively
heat or cool the
environment?

Mechanical energy
Gravity
- Can it fall?
- Can it topple?
- Can suspension
fail?

Vibration
Can it affect the user?
Can bits become
loose?
Will it produce
excessive noise?

Stored energy
Can it spring back?
Are there clips that
can pinch?

Moving parts
Can clothing get
caught?
Can fingers get caught?

Torsion, shear, and tensile
force
Have you considered
excessive loading?

Moving and positioning of
patient
Will the patient need
to be moved?