Test Subcontracting

A custom chemical characterisation protocol and report written to the expectations of the US FDA for ISO 10993-18:2020 data — AET calculation, extraction rationale, and a full listing of equipment, settings and acceptance criteria — so the chemistry you submit is reviewable as well as correct.

Total content heavy metals analysis by microwave digestion with ICP-MS and ICP-OES, following ISO 10993-18.

Non-volatile organic compound screen of a isopropyl alcohol (IPA) migrate by HPLC/Q-ToF/MS, following ISO 10993-18.

Non-volatile organic compound screen of a water migrate by HPLC/Q-ToF/MS, following ISO 10993-18.

Non-volatile organic compound screen of a n-hexane migrate by HPLC/Q-ToF/MS, following ISO 10993-18.

Gravimetric determination of non-volatile residue (NVR) in a isopropyl alcohol (IPA) extract.

Gravimetric determination of non-volatile residue (NVR) in a n-hexane extract.

Gravimetric determination of non-volatile residue (NVR) in a water extract.

Semi-volatile organic compound screen of a isopropyl alcohol (IPA) migrate by GC/MS, following ISO 10993-18.

Semi-volatile organic compound screen of a n-hexane migrate by GC/MS, following ISO 10993-18.

Semi-volatile organic compound screen of a water migrate by GC/MS, following ISO 10993-18.

Quantitative determination of total organic carbon (TOC) in an aqueous device extract.

Volatile organic compound screen of a water migrate by headspace GC/MS, following ISO 10993-18.

Cytotoxicity is the first screen in almost every biological evaluation.

Bacterial reverse mutation (Ames) assay per ISO 10993-3:2014, using Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102.

In vitro chromosomal aberration assay per ISO 10993-3:2014.

Mouse lymphoma (tk) assay per ISO 10993-3:2014.

Complement activation measures the terminal complement complex SC5b-9 generated when human serum meets your device.

Complete hemolysis runs both arms of the ISO 10993-4 hemolysis test in parallel: the device in direct contact with rabbit blood, and an extract of the device against the same blood.

Direct-contact in vitro hemocompatibility places the device itself, not an extract, against fresh blood under static conditions and assesses the blood-interaction markers specified in the study design against negative and positive reference materials.

The platelet and leukocyte count (PLC) study exposes human whole blood to your device and measures whether platelets and white cells are consumed or depleted.

Indirect-contact hemolysis exposes rabbit blood to an extract of the device rather than the device itself and measures the fraction of red cells lysed.

Partial thromboplastin time (PTT) exposes human plasma to your device and measures whether the intrinsic coagulation pathway is activated or inhibited.

Implantation assesses the local tissue response to your material in bone after 13 weeks in the rabbit.

Implantation assesses the local tissue response to your material in bone after 2 weeks in the rabbit.

Implantation assesses the local tissue response to your material in bone after 26 weeks in the rabbit.

Implantation assesses the local tissue response to your material in muscle or subcutaneous tissue after 13 weeks in the rabbit.

Implantation assesses the local tissue response to your material in muscle or subcutaneous tissue after 2 weeks in the rabbit.

Implantation assesses the local tissue response to your material in muscle or subcutaneous tissue after 26 weeks in the rabbit.

Implantation assesses the local tissue response to your material in muscle or subcutaneous tissue after 4 weeks in the rabbit.

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

Vaginal irritation asks whether extracts of your device provoke a local inflammatory response in vaginal mucosa.

KeratinoSens is the in vitro skin sensitization assay for the second key event of the adverse outcome pathway: activation of the Keap1-Nrf2-ARE pathway in keratinocytes.

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 14-day repeated dose study asks whether two weeks of daily exposure to your device's extractables produces a systemic effect.

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