When this test applies
Pyrogenicity is in scope wherever a febrile response would matter clinically — devices contacting blood or cerebrospinal fluid, and implants. ISO 10993-11 covers the material-mediated pyrogen: something leachable from the material itself, as distinct from bacterial endotoxin left by manufacturing. The two are detected by different tests, and a device can pass one and fail the other, which is why both are normally expected.
When to run it
On the sterilised, finished device in its final packaging, because pyrogenicity is a property of what actually ships rather than of the raw material. Run it alongside the bacterial endotoxin test (USP <85>) rather than in place of it.
What a pass tells you
The initial test uses three rabbits, and the material passes when no individual rabbit shows a temperature rise of 0.5 °C or more. If any rabbit reaches that threshold the test is repeated with five additional rabbits, eight in total, and the material passes when no more than three of the eight show an individual rise of 0.5 °C or more and the sum of the eight maximum rises stays within the compendial limit. Worth knowing before you see a result: one responding rabbit escalates the study, it does not fail the device.
What it does not tell you
It does not detect bacterial endotoxin, so it is not a substitute for USP <85>. It also says nothing about cytotoxicity, sensitization, irritation, or what repeated systemic exposure would do — acute systemic injection and the repeated-dose studies are separate endpoints.
Method
Testing per ISO 10993-11:2017 and USP <151>. A single extract is prepared at 90 mL, with the 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 extract is administered intravenously to rabbits and body temperature is monitored against the compendial acceptance criteria.
Choosing a source
This method is available both domestically sourced and internationally sourced. Domestic shortens shipping and simplifies chain-of-custody documentation; international is generally the lower-cost route. Both laboratories are ISO/IEC 17025 accredited and GLP certified, and either report is issued under Groenakker cover, in Groenakker’s report template or in your document template on request at no extra cost. Turnaround is 8 to 9 weeks by either route.
Usually ordered alongside
The bacterial endotoxin test (USP <85>), which is the companion pyrogen test rather than an alternative to it. Acute systemic injection (GRK-4004-02) where that endpoint is also open, and cytotoxicity as the baseline biological screen.
