“Medical grade” is used loosely in this industry. Here is what it actually means on a data sheet, which named grades we run, and the line between an approved material and an approved device.
What "Medical Grade" Actually Means
The phrase gets used loosely, so it is worth being precise. When a polymer is described as medical grade, it usually means some combination of four things:
- USP Class VI, the United States Pharmacopeia biological reactivity classification for plastics.
- ISO 10993, biological evaluation of medical devices, most commonly Part 5 for cytotoxicity.
- A drug master file (DMF) registered with the FDA, which lets a device maker reference the material's confidential data.
- Food-contact compliance, such as EU 10/2011 or an FDA food contact notification.
All four are properties of the raw polymer. None of them are properties of your finished part, and that distinction matters more than anything else on this page.
The Named Grades We Run
Vague material categories are not much use when you are specifying a part, so these are the actual grades rather than "engineering thermoplastics".
TOPAS 5013S-04, cyclic olefin copolymer (COC)
A glass-clear amorphous polymer with an unusually high flow rate, which is why it replicates fine mould detail so well. It carries USP Class VI, ISO 10993, EU 10/2011 and an FDA drug master file, has a very low moisture absorption and low extractables, and its heat resistance takes it through 95°C PCR protocols and gamma or ethylene oxide sterilisation.
It is the grade to reach for in microfluidics, cuvettes, microplates, biochips, labware and optical components, and it pairs naturally with micro moulding where the detail replication matters.
Purell HP570R, medical polypropylene
A homopolymer PP combining high flow with high stiffness, which makes it suited to thin-walled parts where warpage would otherwise be the problem. It is widely used in three-part syringes, closures and general healthcare, diagnostics and labware mouldings, and it is ethylene oxide sterilisable.
Ultraform N 2320 003 PRO AT, medical acetal (POM)
An unfilled BASF acetal copolymer developed specifically for medical product development, holding USP Class VI, ISO 10993-5 cytotoxicity testing, an FDA drug master file and food-contact compliance. Typical uses are functional device parts such as insulin pen and powder inhaler components, plug-in connectors and device handles, where acetal's stiffness and low friction earn their place.
Santoprene 8281-35MED, medical TPV
A soft thermoplastic vulcanizate at Shore A 39, in the thermoplastic elastomer family, designed for medical and healthcare use. It holds USP Class VI, has ISO 10993 testing behind it, is covered by a drug master file, and each medical grade is retested annually for cytotoxicity and heavy metals. It is the grade for soft-touch grips, seals and gaskets, and it can be over-moulded onto a rigid substrate.
Beyond medical: specialty compounds
Not everything demanding is medical. We also run Nilamid B3 CU90, a PA6 compound filled with 90% copper, giving a density of around 5.2 g/cm³. It exists for small parts that need real mass or density in a moulded component rather than a machined metal one.
We do not run PEEK. Saying so saves everybody a conversation.
Where Material Approval Stops
This is the part that gets glossed over in a lot of supplier marketing, so to be blunt about it: a USP Class VI listing on a resin does not make your device compliant. It is one input into your own regulatory work. Classification, testing, validation and your quality system decide whether a finished medical device is approved, and the resin is simply one documented element of that.
Two practical consequences follow.
First, tell your moulder the application early. Several material suppliers require the end application to be declared, and in some cases approved in writing, before a grade is released for a medical device. That is a normal part of the process, but it is not something to discover late.
Second, check the quality system, not just the material. Ours is ISO 9001, which in concrete terms means full traceability on your parts plus logged dimensional and visual checks rather than a badge on a wall. We are not ISO 13485 certified, and we would rather tell you that at enquiry stage than have it surface during an audit.
How to Choose a Grade
In practice the choice is driven by four things: what the part has to do mechanically, whether it needs to be clear, how it will be sterilised, and what documentation your own regulatory route demands. Flow matters more than people expect as parts get smaller, because a high-flow grade is often the difference between a fine feature forming and not forming at all.
If you know the performance requirement but not the polymer, that is a normal starting point. Send us the part and the application and we will suggest grades, or tell you honestly when what you need sits outside what we run. See medical injection moulding or request a quote.
Sources & Further Reading
For independent background on the process, see the British Plastics Federation's guide to injection moulding and the overview on Wikipedia.