How is ISO 10993 Medical Device Biocompatibility Testing Performed?

Medical Device Biocompatiability Testing
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.

A medical device is any equipment used for the purpose of diagnosing, preventing, monitoring, or treating a disease or condition and range from devices as simple as a thermometer or as complex as pacemakers. Medical devices also include combination products such as inhalers.

Medical Device Biocompatibility testing includes testing from the initial screening to performance testing to non-clinical testing and safety testing. Types of biocompatibility testing for medical devices include material characterization, testing for any leachable materials by heating the device to high temperatures and analyzing any extracts for cytotoxicity, irritation testing to determine if repeated exposure to the device will cause an adverse reaction, safety testing to determine any harmful effects of the device or toxins, and more. The turnaround time for performing these types of testings can range anywhere from weeks to months. ISO 10993 addresses biocompatibility testing of medical devices and overall device safety.

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 needed for in vivo and in vitro studies of implant based bone cement medical device 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 to FDA guidelines
  • Biomechanical / medical device laboratory needed for 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 the load of up to 5kg, 3. Compression test – the implant should not slip or crushed while its compressed by surgical instrument, and  4. Biocompatibility test – the implant should not react to human tissues while inside the human body permanently.

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Are you medical technology manufacturer that needs a contract research organization or laboratory to perform your medical device biocompatibility testing, call us at  1-855-377-6821 or Submit Biocompatibility Test Request

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