Biomedical Engineering Reference
In-Depth Information
T
YPICAL
R
EGULATIONS
EH&S regulations are established for the following reasons:
1.
To reduce the potential for human exposures to biological, chemical,
and physical stressors while manufacturing a biomedical device.
2.
To minimize the potential for a detrimental release of a stressor into
the environment during biomedical device production.
3.
To reduce the chance that a release of a stressor from either hazardous
raw materials or wastes was experienced during transport to or from
the biomedical device manufacturer.
Most nations choose to oversee these activities with three to five different
governmental agencies. Yet, since the regulations involved typically are
overlapping in scope/purpose, the individual(s) in charge for compliance at the
manufacturing site normally is/are responsible for the entire gamut of related
regulations. Figure 1 shows the icon for Japan's Ministry of Health, Labor and
Welfare while Figures 2 and 3 provide the representation for the United
Kingdom's Environment Agency and the United States' Department of
Transportation. The EHandS regulations pertinent to the biomedical device
industry include: human health and safety, solid/hazardous substance and
waste transport, solid/hazardous waste generation, toxic substance control, on-
site hazardous substance release, wastewater, storm water, air pollution, and
indoor air quality.
(Source: Japan's Ministry of Health, Labor and Welfare).
Figure 1. Japan's governmental agency in charge of labor.
