Page 88 - Plastics News August 2024
P. 88
PRODUCT NEWS
The difference between silicone and medical
grade silicone
edical grade silicone rubber is a special- nants that could potentially cause adverse re-
ised type of silicone that meets the bio- actions when in contact with human tissue. This
Mcompatibility and safety standards set high level of purity is essential to ensure suitabil-
by regulatory bodies like the FDA and ISO. It is ity in sensitive medical applications.
formulated for use in medical applications where
contact with human tissue, blood and other bod- Another key difference lies in the compounds
ily fluids may occur. This material is known for biocompatibility. Medical grade silicone rubber
its purity, flexibility, durability and resistance to undergoes rigorous testing to ensure it is com-
extreme temperatures. patible with human tissues and fluids. This test-
ing guarantees that the material does not cause
How does silicone rubber differ to med- irritation, toxicity or allergic reactions to confirm
ical grade silicone rubber? it safe for use in direct contact with the human
body. This compares to other silicone rubber
Medical grade silicone often differs from com- compounds that may not meet these biocom-
mercial silicone in several significant ways. patibility standards and are therefore unsuitable
These differences are primarily related to the for many medical applications such as contact
compounds purity, biocompatibility, regulatory with human tissue.
approval and sterilisation capabilities. Medical
grade silicone is often purer than other grades Regulatory approval is another factor that distin-
of silicone and is manufactured under stricter guishes medical grade silicone rubber from other
controls to ensure the elimination of contami- grades. It must comply with the regulations set
90 PLASTICS NEWS August 2024
