Biomedical Engineering Reference
In-Depth Information
traditional manufacturing activities, it is also common for the raw materials
employed in the manufacture of the medical device to have a toxic nature from
the on-set or for the processes used to present a physical hazard to those in the
immediate vicinity of the work being performed.
Figure 4. CNC used to machine device (Permission: Metal Craft).
Figure 5. Injection molding used to mold device (Permission pending: Top Clean
Silicone).
The way most modern societies have chosen to manage and control such
undesirables is through regulation. The following paragraphs provide a
discussion on the EH&S regulations commonly mandated in the biomedical
device industry for the eight given classifications. Due to the international
scope of the material presented, an attempt will be made in this chapter to limit
the coverage of specific regulations and bureaucracies pertinent to individual
countries/unions.
