ISO 10993 Medical Device Biocompatiability Testing
ISO 10993 medical device biocompatibility testing is performed to observe how compatible a device is with living tissue. To be considered biocompatible, a device needs to cause no local or systemic response. Biocompatibility is determined through a series of tests that find the potential toxicity that could result from exposure or contact with the device’s components.
ISO 10993 is a series of standards that evaluate the biocompatibility of medical devices to manage biological risk. This set of standards provides a framework for determining the potential biological risks associated with a medical device and outlines the appropriate tests to assess these risks. Here’s a brief outline of how ISO 10993 Medical Device Biocompatibility Testing is performed:
1. Evaluation and Testing within a Risk Management Process
Before testing, the standard requires a risk assessment according to ISO 14971 to identify potential hazards associated with the device. The type of contact and duration of exposure the device will have with the body dictates the extent and nature of the testing.
2. Selection of Tests
ISO 10993 lists various tests that correspond to different types of body contact (e.g., skin, bloodstream, bone) and contact duration (limited, prolonged, permanent). Based on the initial risk assessment, specific tests are selected to evaluate various aspects of biocompatibility, such as cytotoxicity, sensitization, irritation, acute and chronic toxicity, genotoxicity, carcinogenicity, and reproductive toxicity.
3. Chemical Characterization
Chemical characterization involves identifying and quantifying the chemical constituents of the device. This step is crucial for understanding the composition and potential leachable substances that could affect biocompatibility.
4. Biological Testing
The actual testing phase involves a series of in vitro and in vivo tests:
- Cytotoxicity Tests: These assess whether the device or its leachables are toxic to cells in culture.
- Sensitization and Irritation Tests: These determine the potential for the device to cause allergic reactions or irritation on contact with tissues.
- Systemic Toxicity Tests: These evaluate the device’s potential to cause harmful effects when in contact with the body, either through single or repeated exposure.
- Sub-chronic and Chronic Toxicity Tests: These involve longer-term animal studies to assess the effects of sustained exposure to the device.
- Genotoxicity, Carcinogenicity, and Reproductive Toxicity Tests: These assess the potential for the device to cause genetic mutations, cancer, or reproductive harm.
5. Clinical Evaluations
In some cases, clinical evaluations may be necessary to assess biocompatibility, especially for devices that are new or have novel materials or mechanisms of action.
6. Documentation and Interpretation of Results
After testing, the results must be documented and interpreted in the context of the risk assessment. Any potential adverse effects identified during testing must be evaluated for their clinical relevance.
7. Compliance and Regulatory Approval
The culmination of the biocompatibility testing and risk assessment process is to demonstrate compliance with the relevant regulatory requirements for the device’s intended market. This documentation forms part of the technical file or dossier for regulatory submission.
Conclusion
ISO 10993 Medical Device Biocompatibility Testing is a comprehensive process integral to the medical device development lifecycle. It ensures that devices are safe for their intended use and helps manufacturers navigate the regulatory landscape to bring their products to market. As medical technology advances, the standards are updated to encompass new materials and technologies, maintaining a high standard for patient safety and device efficacy.
Some examples of how Contract Laboratory helped companies facilitate their medical device biocompatibility testing include:
- FDA GLP Product Safety Laboratory needed for biocompatibility testing for medical devices
- FDA GLP Medical Device Product Safety Laboratory needed for ISO 10993-1 biocompatibility studies for implantable bone graft substitutes (granules), xenograft (from bovine bone), and a biphasic calcium phosphate Cytotoxicity- Sensitization- Irritation or intracutaneous reactivity- Systemic toxicity- Subchronic toxicity- Genotoxicity- Implantation
- FDA Contract Research Organization CRO is needed for in vivo and in vitro studies of implant-based bone cement medical devices including material characterization and in vitro biocompatibility and osteogenic function and in vivo bone defect healing ability
- Medical device laboratory needed for biocompatibility testing of long-term orthopedic implants to ISO 10993-1 (Biological Evaluation of Medical Devices)
- FDA cGMP Medical device laboratory needed for product safety and toxicology study testing of water-based personal lubricant including 1) Condom biocompatibility 2) Systemic toxicity 3) Vaginal irritation 4) Dermal sensitization
- FDA cGMP medical device laboratory needed for condom biocompatibility testing in accordance with FDA guidelines
- Biomechanical/medical device laboratory needed for the development of spinal implantable device manufactured with implantable grade PEEK and Titanium 3. The following testing is required: 1. Slippage test – the implant spikes or serration should be strong enough so that it should not slip from the two bones, 2. Load bearing test – the implant should be able to take a load of up to 5kg, 3. Compression test – the implant should not slip or be crushed while it is compressed by a surgical instrument, and 4. Biocompatibility test – the implant should not react to human tissues while inside the human body permanently.
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