About The “Medical Grade “
In order to be used in medical
devices, polymers must fulfill demanding standards. For plastics
manufacturers this means a great deal of investment for products
with restricted market potential. The product and performance
characteristics for “medical grade” polymers are determined at the
discretion of the manufacturer, but everybody selling polymers can
have their own definition of what a medical grade is, and that can
present something of a problem.
The selection of materials for
medical, pharmaceutical or diagnostic applications can be a
difficult task. Strict legal stipulations demand that plastics
comply with standards applicable for these uses. What is necessary
to transform a “standard” polymer into a “medical grade” ?
Defining and regulation
Requirements for materials used, in
the manufacture of medical devices, are specified in various
regulatory requirements and directives. They have to be be safe
and effective and not compromise the safety of patients .The
requirements for medical devices among other things, require
safety, quality and suitability, toxicity and mutual compatibility
with tissues, cells, body fluids and other used materials. The
intended use of the medical device must always be considered in
From a legal perspective it is
the company that brings the medical device onto the market that is
responsible for complying with any applicable regulatory
requirements, but medical grade polymers have no strict
definition, and very often such plastics are sold on the basis of
their biocompatibility alone.
It is estimated that only about
three per cent of global plastics production is destined for
Not every polymer manufacturer will
be willing or even able to meet the healthcare OEM’s stringent
requirements in the medical and pharmaceutical sectors.
Informed suppliers can be identified
by asking them how their medical grades are characterised.
Suppliers sometimes will just say their polymer is tested for
biocompatibility, which does not guarantee each individual batch
(Abstracted from an detailed article
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