Biomedical Engineering Reference
In-Depth Information
Table 9.2: Examples of Hazards
Examples of Energy
Hazards
Examples of Biological
and Chemical Hazards
Examples of
Operational Hazards
Examples of Information
Hazards
Electromagnetic energy
Biological
Function
Labeling
Electricity
Bio-burden?
Bacteria?
Viruses?
Other agents (e.g.,
prions)
Re- or cross-infection?
Animal-based
products?
Any of the above due
to reuse?
Effects due to:
Incorrect or
inappropriate use?
Incorrect
measurement?
Erroneous data
transfer?
Loss or deterioration
of function?
Misuse?
Ignoring a warning
or error message?
Not checking
functionality before
starting?
Are the instructions
for use adequate?
Are the indications
clear?
Contraindications
clear?
Are the performance
criteria clear?
Are the above written
for all end-users?
Line voltage
Is it connected to
mains supply?
Leakage current
- enclosure leakage
current
- earth leakage
current
- patient leakage
current
Is it DC or AC?
Is it single phase or
three phase?
Chemical
Any acids or alkalis?
Any processing
residues?
Any contaminates?
Any additives or
processing aids?
Any cleaning,
disinfecting, or testing
agents?
Can any of the above
cause degradation?
Will it use/transmit
any life-threatening
chemicals (e.g.,
medical gases,
anesthetic products)?
What effects can any
of the above have on
the device itself?
Operating instructions
Written with the end-
user in mind?
Inadequate
specification of pre-
use checks?
Overcomplicated
operating
instructions?
The effects on the
device if any of the
above occur?
Electric fields
Will it produce a
magnetic field?
Can it be affected by
magnetic fields?
Data contamination
through interference?
EMC compatibility?
User error
Effects of:
Lack of attention?
Forgetfulness?
Lack of training?
Ignoring the rules?
Lack of knowledge?
Is there any assembly
that could go
wrong?
Light
Does it emit light?
Can it cause damage
to eyes?
Will it cause
temporary blindness
(flash)?
Does it need to be
used in a dark or light
environment?
Is it a laser?
Warnings
Any side effects?
Any hazards likely
with reuse?
Specification of service
and maintenance
Any special service
instructions before
reuse?
Anything needs
disposal before reuse?
Any pre-use checks?
Biocompatibility
Toxicity of chemical
constituents, e.g.,
- allergenicity/
irritancy
- pyrogenicity
Radiation energy
Ionizing radiation
Is there any?
Is it directional?
How much?
Nonionizing radiation
UV sunburn?
( Continued )
 
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