Subcutaneous Reaction Test (Irritation)

Irritation is another method of assessing the biocompatibility of materials. Irritation can be evaluated using many different models and the choice of evaluation should be based on the end use of the medical device or biomaterial.

The most widely used test method in this regard is the intracutaneous reactivity test, which is defined in both ISO 10993 and USP standards. This assessment is required for all medical devices to comply with the ISO 10993 standard.

The standard “ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process” published by the International Standards Organization (ISO) includes:

• General principles governing the biological evaluation of medical devices within a risk management process
• General classification of medical devices according to the nature and duration of their contact with the body
• Evaluation of relevant data available from all sources
• Identifying gaps in the existing dataset based on a risk analysis
• Identification of additional datasets required to analyze the biological safety of the medical device
• Evaluation of the biological safety of the medical device

This standard applies to the evaluation of materials and medical devices that are expected to come into direct or indirect contact with:

• The patient's body during the intended use
• The user's body (for example, surgical gloves, masks and others) if the medical device is for protection

This standard applies to the biological evaluation of all types of medical devices, including active, inactive, implantable and non-implantable medical devices. This standard also provides guidelines for the assessment of biohazards arising from:

• Risks such as changes in the medical device over time as part of the overall biological safety assessment
• Fracture of a medical device or medical device component that exposes body tissue to new or new materials

Other parts of this standard cover certain aspects of biological assessments and related tests. Device-specific or product standards handle mechanical testing.

Biocompatibility is the ability of a medical device or material to perform in a particular application. A biological risk is a situation of harm to health as a result of reactions associated with medical device or material interactions.

Our organization also provides subcutaneous reaction test (irritation) services 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.