GEN 164 Irritation or Subcutaneous Reaction Test (ISO 10993-10)

The ISO 10993-10 standard, developed by the International Standards Organization (ISO), describes a test method for the evaluation of medical devices and their components according to their potential to induce skin sensitization. This standard includes:

• Details of in vivo skin sensitization test procedures
• Key factors for interpretation of results

In particular, the instructions for the preparation of materials regarding these tests are included in the standard annex (Annex A). The full name of this standard is: ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin sensitization.

This standard assesses potential contact hazards from chemicals released from medical devices that cause sensitization to the skin. Some materials found in medical devices have been tested and documented for their skin sensitization potential. Manufacturers must evaluate each device for potential adverse effects before it is offered to consumers.

For the purposes of this standard,

• An allergen (sensitizer) refers to a substance or material capable of inducing a particular hypersensitivity reaction upon repeated contact with that substance or material.
• Allergic contact dermatitis refers to the clinical diagnosis based on an observed immunologically mediated cutaneous reaction to a substance.
• The blank refers to the extraction medium that does not contain the test material, is kept in the same container as the one holding the test material, and is subjected to the same conditions during its extraction as the test material.
• Reveal refers to the immunological reaction to exposure to a sensitizer in a previously sensitized individual.
• Irritant refers to a localized non-specific inflammatory response to a single, repeated or continuous administration of a substance.
• A negative control refers to a well-characterized material or substance that demonstrates the suitability of the procedure to produce a reproducible, suitably negative, non-reactive, or minimal response in the test system when evaluated with a specific test method.
• A positive control refers to a well-characterized material or substance that demonstrates the suitability of the test system to produce a reproducible, suitably positive or reactive response in the test system when evaluated with a specific test method.

Our organization also provides irritation or subcutaneous reaction test services within the scope of the GEN 164 standard, with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors.