Intracutaneous Reactivity Testing

A big variety of chemical components such as starting materials and processing aids including lubricants and mould-release agents used in the manufacture of medical device, adhesive/solvent residues from assembly process, and sterilant residues from sterilization process may be present in a finished product. It shall be taken into consideration that whether these components have the potential irritation activity. Irritation is characterized by inflammation, redness, swelling, heat, and/or pain. The Intracutaneous Reactivity Testing is an in vivo assay for the assessment of the potential of medical device used as an implant or external communicating device to cause irritation.

STEMart offers in vivo Intracutaneous Reactivity Testing according to the biocompatibility guidelines modified for medical devices.

Standard of Intracutaneous Reactivity Testing

• ISO 10993-10: 2010

Intracutaneous Reactivity Test Principle

Expose the test animals to the extract from medical device by intradermal injection. Observe and grade the tissue reaction (erythema and oedema formation) of each injection site to evaluate the potential of the medical device to produce irritation.

Test Animal for Intracutaneous Reactivity

Adult albino rabbits

Intracutaneous Reactivity Test Procedure

• Intradermal injection

Administer the test substance extracted from medical device with polar or non-polar solvent by intracutaneous injection to the back of the animal on one side of the spine. The solvent controls are injected on the contralateral side of each rabbit.

• Observation of animals

Visualize the formation of erythema and oedema on the injection sites immediately after injection and at 24 ± 2 hours, 48 ± 2 hours and 72 ± 2 hours after injection.

• Data process

Grade the tissue reaction for erythema and oedema and calculate the overall mean score of each test substance and control. Obtain the final test substance score by subtracting the score of the control from the test substance score.

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Reference

• International Organization for Standardization. Biological evaluation of medical devices — Part 10: Selection of tests for interactions with blood. ISO 10993-10; (2010).