When this test applies
Required for devices labelled non-pyrogenic, and for any device with blood, cerebrospinal fluid or implant contact. It is a batch-release and a submission test, not only a characterisation one.
When to run it
On the sterilised, finished device in its final packaging. Endotoxin is a process and handling attribute, so a result on an unfinished sample tells you little about what you will ship.
What a pass tells you
That the measured endotoxin level, reported in EU per device or per mL, is below the limit for your device’s route and contact duration, and that the positive product control recovered within 50–200% — meaning the device eluate did not interfere with the assay.
What it does not tell you
Endotoxin is one specific pyrogen. A material-mediated pyrogen would not be detected here, which is why ISO 10993-11 material-mediated pyrogenicity is a separate test and why regulators generally expect both where pyrogenicity is in scope. It also says nothing about sterility.
Method
Testing per USP <85>. A device eluate is prepared per the compendial method and assayed by kinetic turbidimetric Limulus amebocyte lysate, with a positive product control run to demonstrate absence of interference.
Where it runs
This method is domestically sourced. 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 your document format.
Usually ordered alongside
Material-mediated pyrogenicity where the pyrogenicity endpoint is in scope, and the pooling option where multiple devices are tested as a single pooled result.
