Test Subcontracting

The protocol written before the chemistry runs: extraction conditions, analytical methods and the analytical evaluation threshold defined up front, then the report against it.

Total elemental content is the metals arm of an extractables profile: the device extract is analysed by ICP-MS and ICP-OES and 34 elements are quantified.

The non-volatile organic compounds (NVOC) arm of an ISO 10993-18 extractables profile, run in isopropyl alcohol (IPA).

The non-volatile organic compounds (NVOC) arm of an ISO 10993-18 extractables profile, run in water.

The non-volatile organic compounds (NVOC) arm of an ISO 10993-18 extractables profile, run in n-hexane.

The non-volatile residue (NVR) arm of an ISO 10993-18 extractables profile, run in isopropyl alcohol (IPA).

The non-volatile residue (NVR) arm of an ISO 10993-18 extractables profile, run in water.

The semi-volatile organic compounds (SVOC) arm of an ISO 10993-18 extractables profile, run in isopropyl alcohol (IPA).

The semi-volatile organic compounds (SVOC) arm of an ISO 10993-18 extractables profile, run in n-hexane.

The semi-volatile organic compounds (SVOC) arm of an ISO 10993-18 extractables profile, run in water.

Total organic carbon is the bulk measure of how much organic material comes off your device into water.

The volatile organic compounds (VOC) arm of an ISO 10993-18 extractables profile, run in water.

Cytotoxicity is the first screen in almost every biological evaluation.

The Ames assay asks whether an extract of your device causes gene mutation in bacteria.

The chromosomal aberration assay asks whether your device’s extractables break or rearrange chromosomes.

The mouse lymphoma assay asks whether your device’s extractables cause mutation in mammalian cells.

Complement activation asks whether your device triggers the immune cascade that a foreign surface in the bloodstream can set off.

Complete hemolysis runs both arms in parallel: the device surface in direct contact with blood, and an extract alongside it.

Direct contact hemocompatibility asks how your device behaves against whole blood.

Platelet and leukocyte counts ask whether your device consumes blood cells.

Indirect contact hemolysis asks whether substances that leach out of your device rupture red blood cells.

Partial thromboplastin time asks whether your device disturbs the clotting cascade in either direction.

Bone implantation asks what the osseous site does around your device.

Bone implantation asks what the osseous site does around your device.

Bone implantation asks what the osseous site does around your device.

Implantation asks what the tissue does around your device once it is in place.

Implantation asks what the tissue does around your device once it is in place.

Implantation asks what the tissue does around your device once it is in place.

Implantation asks what the tissue does around your device once it is in place.

Irritation asks whether an extract of your device provokes a local inflammatory response in living tissue.

Vaginal irritation asks what the mucosal tissue does in response to your device’s extractables.

KeratinoSens is the in vitro route to the sensitization endpoint.

The guinea pig maximisation test is the reference animal method for sensitization.

Acute systemic injection asks whether a single exposure to your device's extractables produces a systemic effect.

Material-mediated pyrogenicity asks whether substances leachable from your device provoke a febrile response.

The 28-day dual route study asks whether four weeks of daily exposure to your device's extractables produces a systemic effect.

Repeated-dose systemic toxicity asks whether daily exposure to your device's extractables accumulates into a systemic effect a single acute dose would miss.