Biomedical Engineering Reference
In-Depth Information
device manufacturing plant. Typically, there is a table that is established that
provides various bits of information regarding the material of concern. The
table includes identification numbers, packing groups, prohibited activities,
etc, for numerous manufacturing substances/wastes. If there is an emergency
release of either a hazardous substance or waste, qualified drivers and
responders have manifests or shipping papers that provide useful information
on the identity and hazards associated with the cargo. Solid wastes are
generally regulated separately and distinct from hazardous wastes. The
difference in the two is normally defined by such characteristics as corrosivity,
flammability, toxicity, and reactivity. Nations have different criteria or
thresholds used to differentiate between whether a substance or waste in the
solid form is either solid or hazardous from a regulatory standpoint (U.S.
Environmental Protection Agency, 2010; European Environmental Agency,
2009; Australian Environmental Protection Authority, 2010).
M
AJOR
B
IOMEDICAL
D
EVICE
M
ANUFACTURING
P
ROCESSES
The major manufacturing processes found in the biomedical device
industry can be generalized into the following classifications (Handy and
Lafreniere, 2007):
1.
Sterilization
2.
Cleaning, etching, and surface preparation
3.
Adhesive application
4.
Coating application
5.
Drilling, grinding, cutting, and other light production machining
6.
Welding and soldering
7.
General maintenance activities
8.
Laboratory research and testing
With each of the above activities, there is a potential of unwanted by-
products/wastes being produced during the manufacturing process. Figure 4
and Figure 5 provide examples of typical manufacturing processes being
employed in the industry. Take note of the similarities (and differences)
between these activities used to make a biomedical device and the common
manufacturing processes used in traditional industries. Additionally, like
