Biomedical Engineering Reference
In-Depth Information
CASE STUDY 9.2
A single use device is to be steam sterilized at the point of use using a desktop sterilization unit.
This unit also performs washing. Using
Table 9.2
determine any potential hazards that may be
p
art of your risk analysis.
Potential Hazard
Whom?
What?
Why?
Electricity
Line voltage
Staff
Electric shock
Death
Burn
Leakage current
-
enclosure leakage
current
Staff
Electric shock
Death
-
earth leakage
current
Staff
Electric shock
Patient
Abrupt end of
treatment
Potential for injury
Other devices
Abrupt shutdown
Potential for injury
Is it DC or AC?
Device
Breakdown
No sterilization
thereafter
Is it single phase or
three phase?
Device
Breakdown
Staff
Electric shock
Electric fields
Will it produce a
magnetic field?
Other devices
E-Mag field effects
Interference
Patient
E-Mag field effects
Attracting metals
Affecting pacemakers
Can it be affected
by magnetic fields?
The devices
E-Mag field effects
Interference
Attracting metals
Data
contamination
through
interference?
Other Devices
E-Mag field effects
Interference
EMC compatibility?
Other Devices
E-Mag field effects
Need for EMC test
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?
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