Acute Systemic Injection Test

Acute Systemic Injection Test

The Acute Systemic Injection test provides general information about health hazards that may result from acute exposure from a medical device or a chemical. Animals are dosed intravenously and / or intraperitoneally with test product extracts or liquid chemical and then observed at 24 ± 2, 48 ± 2, and 72 ± 2 hours for various signs of toxicity.

Acute Systemic Injection Test

Material Mediated Pyrogen evaluates the ability of a chemical or other substance in or on a medicinal substance to produce a pyrogenic response. Animals are dosed with test product extract by intravenous injection and observed for 3 hours. This observation period looks for a temperature change of less than + 0.5 ° C in each animal.

These tests can be performed on any device that will touch the inside of the patient's body. These tests comply with ISO 10993-11 and ISO 10993-12 standards.

Applicable Standards

  • ISO 10993-11
  • ISO 10993-12
  • USP <151>

Sample Features

  • SCX310: 2 complete devices, each device should be 120 cm2 or 4 grams. CSS Approval is required to meet TAT.
  • SCX315: 10 mL. CSS Approval is required to meet TAT.
  • SCX320: 900 cm2 or 30 grams. CSS Approval is required to meet TAT.

EUROLAB, with its highly expert team and internationally accredited laboratories, Acute Systemic Injection Test It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.

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