Biodegradable material compact ability with human body

1. Medical Grade Material

2. In Brief
Materials used in the healthcare and medical setting must often carry the title
"medical grade." But what defines a material as "medical grade"?
Biocompatibility refers to "the ability of a material to perform with an
appropriate host response in a specific application" (William's definition), and
can be measured in different ways, depending on the context of the medical
device. Because they come in contact with the human body, materials are
tested for biocompatibility and safety in order to receive the "medical grade"
designation.

3. Medical Grade Polymers
In the United States, the Food and Drug Administration (FDA) Center for Devices and
Radiological Health (CDRH) regulates devices implanted into the body. Rightly so,
patient safety drives manufacturing processes that minimize polymerization residues
and results in the careful selection of additives such as plasticizers and antioxidants.

4. Plastics
Plastics are valued for use in the medical setting for many reasons, including:
toughness
transparency
sterility
transportability
flexibility

5. silicone (polysiloxane) polymers
Many medical devices contain silicone (polysiloxane) polymers. Medical grade silicones are generally
grouped into three categories:
non-implantable
short-term implantable
long-term implantable.
Silicones are highly useful in the healthcare setting because they exhibit the following characteristics:
low toxicity
low chemical reactivity
thermal stability
resistance to oxygen, ultraviolet (UV) light, and ozone
electrical insulation properties
high gas permeability
the ability to repel water and form watertight seals

6. Biocompatibility
Biocompatibility is one of the most important aspects when choosing a material for a
medical application. Biocompatibility means that the properties must be biologically
compatible and not react to other materials or living tissue.

7. Patient safety
Patient safety is a driving factor for manufacturing medical devices. Manufacturers
want to reduce and eliminate polymerization residues, making material selection a
crucial aspect of building safe medical equipment. Silicone has proven to be the top
material for high-quality medical grade seals.

8. Tests to classify medical grade materials
In order to effectively determine if a material can be deemed medical grade, various
rounds of testing must be done. United States Pharmacopeia (USP) testing is used to
evaluate biological responses to elastomers, plastics and other polymeric material
that may come into contact with human skin.
Another form of testing on medical grade materials is ISO 10993. This test follows the
International Organization for Standardization (ISO) guidelines that ensure materials
and products are fit for their purpose. Manufacturers of medical grade materials will
label their products with the fitting ISO classification to provide specifications and
references for materials.