Test Description
ISO Maximization Sensitization testing is an in vivo method used to evaluate whether a medical device or its chemical constituents can cause allergic reactions after repeated exposure. This test is typically performed using guinea pigs, which are highly responsive to dermal sensitizers. The method involves exposing animals to device extracts under conditions that enhance immune response, helping identify materials that may cause delayed hypersensitivity. It is a critical part of biocompatibility assessments for devices that contact breached skin, mucosal membranes, and internal tissues.
Why This Testing is Performed
This test is conducted to:
- Detect potential allergens in medical device materials.
- Prevent adverse immune responses in patients, such as rashes or inflammation.
- Fulfill regulatory requirements for biocompatibility, especially for long-term or repeated-contact devices.
- Support risk assessments during product development and premarket approval processes.
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Steps in Conducting This Test
- Preparation of Extracts: Device materials are extracted using solvents under ISO 10993-12 conditions.
- Induction Phase: Animals are exposed to the extract with an adjuvant to stimulate immune response.
- Rest Period: A recovery period allows immune sensitization to develop.
- Challenge Phase: The extract is reapplied to assess whether a hypersensitivity reaction occurs.
- Evaluation: Skin reactions such as redness or swelling are scored to determine sensitization potential.
Standards, Guidance, and Regulations
- ISO 10993-10: The primary standard for irritation and sensitization testing of medical devices.
- ISO 10993-12: Specifies sample preparation and extraction protocols.
| Test Code | Variation |
|---|---|
| TI261-300 | Extract |
| TI261-302 | Extract Rechallenge |
| TI261-304 | Positive Control Report |
| TI261-306 | Solution |
| TI261-307 | Solution Rechallenge |
