Biomedical Engineering Reference
In-Depth Information
pollutants like chlorinated solvents and industrial acids/bases. For example, a
country may regulate these potential emissions as either criteria pollutants or
ambient air quality listed pollutants. Thresholds are typically based upon
regulatory values for emission factors or on mass balance calculations.
As far as solid/hazardous waste generation/transport, many nations
establish regulatory programs which require the manufacturer to report the
maximum quantities of any cleaning or etching chemical that would be kept
on-site at any particular moment over the course of the year. The transport of
such chemicals is usually handled by an office or department of transportation
at one or more levels of government. In addition, water wastes and sludges
contaminated by any of these chemicals are typically handled and disposed of
properly based on local or regional regulations. Generation of any waste is
normally classified by both the level of toxicity of the waste as well as the
weight/mass generated, and proper controls are established to prevent the
leakage or release of such agents into the storm water or any adjacent rivers or
streams.
Most biomedical device manufacturers either have in place or are
implementing some sort of continuous improvement program to alleviate any
of the concerns regarding the surface preparation process as well as any other
activity that can result in exposures or releases of such toxic chemicals. For
example, the ISO 14001 standard for environmental management systems is a
common strategy employed by many of the manufacturers of biomedical
devices.
EH&S
AND
A
DHESIVE
A
PPLICATIONS
While there are various techniques (e.g., mechanical fastening, welding,
soldering, etc.) for joining biomedical device parts together, adhesive
applications are typically used when dissimilar or very thin materials are
required to be attached. The most common adhesives used in the biomedical
device industry include urethanes, cyanoacrylates (or superglues), acrylics,
epoxies, and silicones. Like the surface preparatory agents, adhesives quite
often attack the skin, eyes, and respiratory tract in an overexposure. This group
can also be considered sensitizers, causing allergic reactions in those exposed
for prolong periods of time. However, many of the adhesives do not have
established OELs; yet, exposure standards have been determined for any of the
hazardous ingredients in the formula and can be evaluation through proper
interpretation of the material safety data sheet (MSDS).
