When this test applies
USP Class VI is a plastics classification, not an ISO 10993 biological evaluation. It is what customers, drug partners and some regulators ask for by name as a materials credential, and it is commonly required for container-closure and pharmaceutical-contact components. If your goal is a device submission under ISO 10993-1:2025, this suite is not a substitute for the biological evaluation — it is a different question with a different answer.
When to run it
Once the resin grade and processing are fixed, because Class VI attaches to the material as processed. It is often commissioned early as a marketing and qualification credential, well ahead of any device-specific testing.
What a pass tells you
That the material achieved Class VI: the in vitro reactivity grade under USP <87> and the in vivo systemic, intracutaneous and implantation responses under USP <88> all met the acceptance limits in those chapters, across the four specified vehicles. The four vehicles are the point — Class VI is the most demanding of the classes precisely because it requires the full vehicle set and the implantation test.
What it does not tell you
It says nothing about your finished device. Class VI covers the plastic, tested to compendial protocols with compendial vehicles and geometries; ISO 10993-1:2025 asks about the device as used, by its actual contact type and duration. A Class VI material still needs cytotoxicity, sensitization and the rest of its endpoint set addressed for the device. It also does not cover chemical characterisation, genotoxicity or hemocompatibility.
Method
Testing per USP <87> and USP <88>. Extracts are prepared using the four vehicles USP <88> specifies, with extraction ratio per ISO 10993-12: 6 cm²/mL for material under 0.5 mm thick, 3 cm²/mL at 0.5 mm or thicker, or 0.1 to 0.2 g/mL where surface area is indeterminate. The in vitro reactivity test is run alongside the systemic injection, intracutaneous and implantation tests.
Where it runs
This method is internationally sourced. The laboratory is ISO/IEC 17025 accredited and GLP certified, and the report is issued under Groenakker cover, in Groenakker’s report template or in your document template on request at no extra cost.
Usually ordered alongside
A biological evaluation plan (GRK-1001), which establishes what your device actually needs beyond the materials credential. Chemical characterisation is the usual companion where a drug or pharmaceutical-contact application is involved.
