Systemic Toxicity
ISO 10993-11 covers material-mediated systemic effects, from pyrogenicity and acute injection through 14- and 28-day repeated dose. Select the study the biological evaluation named; this page is not a package.
Choose the study the evaluation namedISO 10993-11 scales with exposure: acute for limited contact, 28-day repeated dose for prolonged, longer still for permanent. Systemic toxicity is also the endpoint most often closed by chemistry and a toxicological risk assessment instead of an animal study — worth settling before you book one.
Systemic Toxicity: Acute Systemic Injection, 2 Extracts (GLP)
Acute systemic injection asks whether a single exposure to your device's extractables produces a systemic effect.
GRP-4004-ACUTE
Systemic Toxicity: Material Mediated Pyrogenicity, Rabbit (GLP)
Material-mediated pyrogenicity asks whether substances leachable from your device provoke a febrile response.
GRP-4004-PYRO
Systemic Toxicity: Subacute / Subchronic Toxicity 14 Day Repeated Dose, 2 Extracts (GLP) - Internationally Sourced
The 14-day repeated dose study asks whether two weeks of daily exposure to your device's extractables produces a systemic effect.
GRK-4004-03X
Systemic Toxicity: Subacute / Subchronic Toxicity 28 Day Dual Route Repeated Dose, 2 Extracts (GLP)
The 28-day dual route study asks whether four weeks of daily exposure to your device's extractables produces a systemic effect.
GRP-4004-28DR
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