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medical grade

Medical grade plastics

medical grade plastic materials that meet FDA and USP Class VI requirements. Our high-purity materials have been used in applications from Medical Wands to Sterilization Trays and Endoscopic Probes & Devices. The majority of these products perform well even after virtually unlimited autoclaving cycles. Once we understand your application, our knowledgeable salespeople can provide you with specific medical certifications, as well as lot & batch traceability.

USP Class VI Approved Plastic Materials

USP (U.S. Pharmacopoeia) Class VI judges the suitability of plastic material intended for use as containers or accessories for parenteral preparations. Suitability under USP Class VI is typically a base requirement for medical device manufacturers.

Medical grade silicone

Elsmar Cove runs discussion forums on quality assurance, business standards and compliance. Here are comments from their forums about “medical grade”
If you search Elsmar’s relevant forums you’ll find numerous discussions around the term “medical grade”. In short, this is more a marketing term than a regulatory or even a technical one. It is loosely defined and therefore could have lots of different meanings. In general, I’d say it’s the minimal starting point for a candidate adhesive evaluation (except in special cases). If an adhesive is NOT tagged by its manufacturer as “medical grade” then it’s more likely to miss on some important requirements. This doesn’t mean that an adhesive tagged as medical grade automatically qualifies as anything; it just means somewhat better odds. It’s always the user’s responsibility to verify and prove that all applicable requirements are met in the final product state.

I agree with Ronen’s comments. A bit more:

Some industrial materials are made with quite unclean processes because if what one is going to do with the material is threadlock some four inch bolts on a steel mill rolling press, biological cleanliness is quite beside the point.

So a medical grade of the same material might have the same nominal formulation, but it’s made in a cleanroom environment in pristine, regularly cleaned, validated equipment and the raw materials and process cleanliness are tightly controlled. Obviously if your application may have indirect patient contact or may be associated with a patient-critical aspect of your product, the medical grade would be your choice.

On the other hand, sometimes “medical grade” means they sell you the exact same product as their already-suitable-quality industrial grade, but you get to pay 200% more in return for them using a different label and including a certification sheet. Typically in this case their entire production is done to medical quality standards, but they allocate those production costs only to their medical customers so that their industrial product can remain cost competitive.

And one hears of instances where the product isn’t suitable quality, but it’s sold in a marked-up “medical grade” version anyway to take advantage of customers that will pay the difference.

It’s up to you to end up with a safe and effective product. You can do that by doing your homework to determine what vendor you can trust (for which good reputations over long periods of time in business, certs from them of reputable third party auditing and testing, and contractural promises not to change formulations and processes, can be useful) and paying any markups involved, or by technically understanding the material involved and your use of it, performing your own testing as needed to verify and validate, putting controls in place to assure detection if a material changes between received batches due to a raw materials or process change, and selecting what to buy and use on that basis. Often it’s simpler, faster and thus cheaper to work with the well-organized, medical-requirements-aware maker than to do it on your own.

In any case, merely assuming that because a vendor labels a material as “medical grade” it’ll be safe and effective in a medical device is an insufficient approach.

First of all you will not get a non medical grade adhesive. You get adhesive and medical grade adhesive. It helps one to select adhesive for a medical device application based on provided details that gives a fair assurance to the user about meeting bio-compatibility requirements of the finished medical device. Rest of the mechanical properities are to be validated by the user before use. Even the manufacturer perhaps will not reveal more details except terming medical grade and references to the various standards to which the adhesive properties have been tested. Perhaps the word Hypoallergic is mentioned within the technical litrature of such an adhesive which means “to have a decreased tendency to cause allergies; hypo means less, not none.”