When this test applies
Where particulate burden matters clinically — devices in the fluid path, devices delivering to the vasculature, and devices where a specification or a predicate sets a particulate limit. It is a device-specification test rather than an ISO 10993 biological endpoint.
When to run it
On the finished, packaged device, and after any change to surface finish, cleaning or packaging. Particulate counts are a manufacturing and handling attribute, so they move when the process moves.
What a pass tells you
That cumulative particle counts at 10 µm and 25 µm fall within the limits for your dosage form or device specification. The comparison is against your specification — so the result is only as meaningful as the limit you have justified.
What it does not tell you
Light obscuration counts and sizes particles; it does not identify them. If a count is out of specification, characterising what the particles are is separate analytical work. It also says nothing about any biological endpoint.
Method
Testing per USP <788> Method 1. The device surface is extracted and particle counts are determined on the extract by light obscuration, with cumulative counts reported at 10 µm and 25 µm.
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
Gas pathway analysis for breathing-circuit devices, and chemical characterisation where the particulate finding needs chemical follow-up.
