When this test applies
USP Class VI is a material-level designation that resin suppliers, component manufacturers and pharmaceutical packaging and processing suppliers use to show a plastic has passed a defined battery of biological reactivity tests. It is frequently requested in supplier qualification, in single-use bioprocess equipment and in pharmaceutical contact materials. It is not an ISO 10993 evaluation and does not replace one for a finished medical device.
When to run it
When a customer, specification or regulatory pathway specifically asks for a USP Class VI designation — typically on a raw material or component rather than a finished device. Run it on the material in the form and process condition that will be supplied, because the designation applies to what was tested. If the goal is a medical device submission, start with a biological evaluation plan instead; ISO 10993-1 is what the device reviewer will ask for.
What a pass tells you
That the material met the acceptance limits in both chapters: the in vitro reactivity grade under USP <87>, and the systemic injection, intracutaneous and implantation responses under USP <88>, each against concurrent controls. Meeting all of them supports a Class VI designation for the material as tested.
What it does not tell you
Nothing about sensitization, genotoxicity, hemocompatibility, pyrogenicity or chemical characterisation — none of these are in the USP battery, and all of them can be required for a device under ISO 10993-1. A Class VI material can still fail a device-level evaluation, and a Class VI certificate on a resin does not transfer to a moulded, sterilised part without justification.
Method
Testing per USP <87> (in vitro) and USP <88> (in vivo). Extracts are prepared in the four USP <88> vehicles — sodium chloride injection, 1-in-20 alcohol in sodium chloride injection, polyethylene glycol 400 and vegetable oil — at the chapter's extraction conditions. The in vitro arm runs the biological reactivity test on cultured cells; the in vivo arm runs systemic injection and intracutaneous tests with each extract and an implantation test with material strips, all against controls. Extraction ratio follows 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.
Where it runs
This method is internationally sourced (OUS). The laboratory is ISO/IEC 17025 accredited and GLP certified, and the report is issued under Groenakker’s ISO 13485:2016 certified quality system, in Groenakker’s report template or in your document template on request at no extra cost.
Usually ordered alongside
Where the material will end up in a medical device, the ISO 10993 battery the device actually needs — cytotoxicity, sensitization and irritation at minimum — set by a biological evaluation plan. For pharmaceutical contact materials, extractables screening under ISO 10993-18 or USP <1663> is the usual companion.
