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Medical-grade plastics: what the term means and which grades exist

What "medical-grade" means in practice

Neither US nor EU law defines a "medical-grade plastic". FDA reviews devices, not raw materials: its biocompatibility resources say the agency makes its decision on the device in its final finished form and does not clear or approve the individual materials used to make it (FDA: Basics of Biocompatibility). So a resin's medical label tells you what the supplier is prepared to support, not what a regulator has accepted.

Several groups have tried to pin the term down. In Germany, the VDI 2017 guideline describes what a plastic intended for medical devices, in vitro diagnostics and primary pharmaceutical packaging should come with, covering biocompatibility, formulation consistency, change management and supply (VDI 2017, contents and scope, PDF). ASTM has opened a work item, WK89662, for a guide to the criteria and classification of medical-grade polymers for non-implantable applications (ASTM WK89662). The North America Medical-Grade Materials Consortium (NAMGMC) has published its own guidelines for defining and classifying medical-grade materials (NAMGMC guidelines, PDF). None of these is a legal requirement, but they converge on the same idea: the grade is defined by documentation and supply commitments as much as by chemistry.

In practice, engineers comparing medical grades look for the same handful of commitments:

• Biocompatibility data on the resin. Usually USP Class VI, selected ISO 10993 endpoints such as cytotoxicity, or both, tested on molded samples or their extracts.
• A fixed formulation with change notification, so the material you qualified is the material you keep receiving.
• FDA master file support (a Drug Master File or Device Master File) that you can reference in a submission with the supplier's authorization.
• Sterilization data: which methods the supplier has tested, and at what dose, temperature or number of cycles.
• Healthcare supply terms, which some suppliers publish and others share on request.

MedResin records the biocompatibility, master-file and sterilization statements, because suppliers publish those grade by grade. Formulation-lock and change-notice policies vary by company and are best confirmed with the supplier directly.

The dataset at a glance

A grade counts as "stated" only when its cited source says so. Blank means the source is silent, which is not the same as "no". The numbers are recomputed from the public data every time the site is built.

Medical-grade plastics by polymer group

The 22 polymer groups below run from commodity resins used in single-use disposables, such as polypropylene and polyethylene, to high-performance polymers for reusable instruments, such as PEEK, PEI and the sulfones. The counts reflect the suppliers and documents in MedResin, not the whole market: a group with a single manufacturer here may have many more suppliers in practice.

How the ISO 10993 count works: a grade counts as stating ISO 10993 when its supplier references ISO 10993 testing or compliance for it, including family- or portfolio-level statements that name the grade's product line. A statement that cites only cytotoxicity testing (ISO 10993-5) is not counted as an ISO 10993 statement; the grade page notes it instead. "USP VI stated" and "ISO 10993 stated" count supplier statements, not test results.

Four groups also have a subset page limited to the families used for catheters and tubing: Aromatic TPU (30) · Polyamide (PA12, transparent PA) (8) · Polyethylene (HDPE, LDPE, UHMW-PE, plastomer) (16) · Styrenics (ABS, ASA, MABS, MBS, SAN, SBC, SMMA, S-TPE) (2).

Sterilization compatibility matrix

Each cell shows how many grades in the group have the method stated as compatible, limited or not suitable. Read it as a map of what suppliers document, not as a ranking of polymers. Two patterns stand out. EtO is the most widely documented method, stated as compatible for 282 of the 338 grades. Steam is where suppliers most often state restrictions: 50 grades are listed as limited and 83 as not suitable for autoclaving. VHP is documented far less often, for 73 grades.

Each cell: stated yes / limited / stated no. The rest of the group's grades have no statement for that method in the cited source. Numbers link to the grades.

The methods stress plastics in different ways. Gamma and e-beam irradiation suit sealed single-use products, but radiation can break or crosslink polymer chains, so some resins need radiation-stabilized grades and properties can keep changing after exposure. EtO runs at low temperature, which suits heat-sensitive materials and assemblies, but the gas has to be aerated out afterwards. Steam is the hardest on plastics because it combines heat with moisture, which is why high-temperature polymers dominate reusable instruments. VHP is a low-temperature oxidative process that fewer suppliers address. For sources and detail, see the sterilization methods guide, the gamma guide, the autoclave guide, the EtO tubing guide and the per-method lists under Sterilization.

Biocompatibility statements: USP Class VI and ISO 10993

185 grades list USP Class VI and 150 have an ISO 10993 statement in their cited source, with 7 more carrying a limited ISO 10993 statement; 137 state both. A further 25 grades cite only cytotoxicity testing (ISO 10993-5 or unspecified), which is not counted as an ISO 10993 statement (details). The two are not interchangeable. USP Class VI is a fixed set of in vivo tests on material extracts. ISO 10993-1 frames the biological evaluation of the finished device around the nature and duration of body contact, and it underpins FDA's biocompatibility guidance (FDA guidance on ISO 10993-1). Resin-level data from either is supporting evidence for your device evaluation, not a substitute for it. The USP Class VI vs ISO 10993 guide compares them in detail, and the USP Class VI list and ISO 10993 list show the grades.

FDA master files

105 grades cite an FDA master file in their source: 97 reference a Drug Master File (DMF) and 33 a Device Master File (MAF), and some reference both. A master file lets the supplier give FDA confidential formulation and test information without disclosing it to customers. A device or drug maker refers to it with the supplier's letter of authorization. Where a source gives the file number, the grade page shows it.

Grades by manufacturer

Company and brand names are used only to identify products, and MedResin isn't affiliated with any manufacturer. The counts reflect the public literature indexed so far, not each company's full medical portfolio.

Common questions

• Can PEEK be autoclaved?
• Is polycarbonate autoclavable?
• Which polypropylene grades are gamma-stable?
• Which plastics state USP Class VI?
• Which plastics reference ISO 10993 testing?

How this page is built

Every number here is computed from the same public data as the grade pages, at build time. Grade data was last checked 2026-10-16. See About the data for what yes, limited, no and blank mean, and use Suggest a correction if a supplier document says otherwise. To search individual grades, use the filterable database.