ISO Subcutaneous Implantation Study

ISO Subcutaneous Implantation testing evaluates the local tissue response to medical device materials when implanted under the skin. This in vivo test helps determine the biocompatibility of solid, porous, or degradable materials by observing inflammation, fibrosis, or necrosis over time. It is commonly used for devices intended for  implantation or those that contact breached tissue. The test provides critical insight into how the body reacts to the material, supporting safety assessments during product development and regulatory submissions.

Why This Testing is Performed

This test is conducted to:

• Assess the local biological effects of device materials after implantation.
• Identify adverse tissue responses such as inflammation, necrosis, or fibrosis.
• Support biocompatibility evaluations for regulatory approval.
• Ensure that materials used in implants or wound-contacting devices are safe for use.
• And for absorbable materials, assess the absorption profile.

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Steps in Conducting ISO Subcutaneous Implantation Testing

1. Sample Preparation: Test and control materials are cut to size, sterilized, and prepared under aseptic conditions.
2. Implantation: Samples are surgically implanted into subcutaneous tissue of laboratory animals (commonly rabbits or rats).
3. Observation Period: Animals are monitored over a defined period (e.g., 7, 28, or 90 days) depending on the material type.
4. Tissue Harvesting: At the end of the study, tissue surrounding the implant is excised.
5. Histological Evaluation: Tissue is examined microscopically for signs of irritation, inflammation, or integration.

Standards, Guidance, and Regulations

• ISO 10993-6:2016: The primary standard for evaluating local effects after implantation. It applies to solid, porous, degradable, and absorbable materials.
• ISO 10993-12: Provides guidance on sample preparation and extraction conditions.