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TÜV SÜD America Inc.
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TÜV-SÜD - Biocompatibility Testing Services

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In the medical field, practitioners utilize a range of devices to address patient health, from diagnosis to surgery. When the patient comes into contact with a medical device or material, it should fulfill its intended function without harming the patient. Therefore, all medical devices need to undergo a thorough biological risk assessment to protect the patient from any toxic, physiological, immunogenic or mutagenic effects from the device. This can be achieved with biocompatibility testing.

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As an integral part of biological risk assessment, biocompatibility testing assesses the compatibility of medical devices with a biological system. It studies the interaction between the device and the various types of living tissues and cells exposed to the device when it comes into contact with patients. 

The goal for all medical device manufacturers is to provide maximized benefits to patients while minimizing levels of biological risks. This requires them to comply with stringent biocompatibility testing requirements set by international regulatory bodies to ensure that their devices are medically safe to use before being made available in the market.

Chemical Characterization of Medical Devices

Discover the specifics of the chemical characterization process, the importance in the overall evaluation of medical device safety, and more.

CHOOSE A GLOBAL LEADER IN TESTING SERVICES

TÜV SÜD is globally recognized and trusted for its quality and safety as a third-party one-stop testing provider. We offer a suite of testing services required for medical devices and help manufacturers and suppliers meet global regulatory standards independently.

Our BioCompatibility Testing Services

TÜV SÜD provides the following biological risk assessment tests to help manufacturers meet biocompatibility testing requirements of the International Organization for Standardization (ISO), U.S. Food and Drug Administration (FDA) and American Society for Testing and Materials (ASTM).

  • Cytotoxicity - ISO 10993-5: Cytotoxicity tests are conducted to evaluate the general toxicity level of the medical device or material on cell culture through in vitro elution and agarose overlay methods.
  • Genotoxicity - ISO 10993-3 & FDA: Genotoxicity tests are required to identify the presence of toxins that can impact the genetic material of cells. Following the ISO requirements, we examine:
    • Gene mutation through the bacterial mutagenicity test/bacterial reverse mutation assay
    • Chromosomal damages via in vitro chromosomal aberration assay through mouse lymphoma assay and/or in vivo
    • DNA damage through in vitro / in vivo chromosomal aberrations assay and in vitro / in vivo erythrocyte micronucleus test 
  • Hemocompatibility - ISO 10993-4 & ASTM: Hemocompatibility tests help evaluate the effects blood-contacting medical devices have on blood and blood components through hematology and thrombosis tests. 
  • Irritation - ISO 10993-10: Irritation testing assesses the medical device for skin irritability through i.e. primary skin, ocular and intracutaneously reactivity tests and in vitro skin irritation tests. 
  • Sensitization - ISO 10993-10: Sensitization tests are conducted to evaluate possible adverse cutaneous reactions of the immune system to the medical device through in vivo and in vitro testing methods. 
  • Systemic Effects of Systemic Toxicity and Pyrogenicity - ISO 10993-11 and ASTM: Acute to chronic systemic toxicity tests assess effects of medical devices in vivo. Pyrogenicity tests are carried out to test for material-mediated fever-causing compounds called pyrogens that impact patients when they come in contact with the medical device.
  • Implantation - ISO 10993-6: Implantation tests evaluate the effects of medical devices on the surrounding living tissue at both macroscopic and microscopic levels.
  • Chemical Characterization - ISO 10993-18: Chemical characterization is required to identify the quantities of extractables and leachables that migrate from a medical device when it is used or challenged.
  • Toxicological Risk Assessment - ISO 10993-17: A toxicological risk assessment of extractables and leachables help quantify associated risks based on exposure and safe intake dose.
  • Sterility Testing - ISO 11737 series: Bioburden testing, as part of sterility testing, helps to determine the population of microorganisms on a medical device that has not been sterilized. 
  • Sterile Barrier System - ISO 11607 & EN 868 series: Sterile barrier tests are required for the validation of a medical device’s packaging system to ensure the device maintains its sterility and aseptic quality before use.

YOUR BENEFITS AT A GLANCE

  • Expert Partnership: TÜV SÜD has extensive experience in all types of medical devices and regulatory requirements across markets. 
  • Reduce Time to Global Markets: With our in-depth insight of global product quality and regulatory requirements, TÜV SÜD optimizes your costs and minimizes time-to-market.
  • Single Source Testing Solution: Together with our wealth of knowledge in complex regulations globally, TÜV SÜD provides a complete suite of testing solutions according to your needs.