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About The “Medical Grade “ Polymer Dilemma


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 this process.


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 healthcare industry.


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 is tested.


(Abstracted from an detailed article at the Ref : )


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