Biocompatibility Testing for Medical Devices

Biocompatibility testing for medical devices

Achieve regulatory compliance and global acceptance

Achieve regulatory compliance and global acceptance

Read our Biocompatibility Testing FAQs

ENSURE PATIENT SAFETY WITH BIOCOMPATIBILITY TESTING

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.

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.

Download White Paper


How We Can Help you

TÜV SÜD provides a comprehensive range of medical device testing solutions required by relevant regulatory frameworks worldwide. We offer a complete biocompatibility testing panel for medical devices through our state-of-the-art laboratories and high standards of data and quality reporting to address the testing needs of small and large-scale manufacturers.

Our team of medical doctors, engineers and toxicologists possess the technical, clinical and regulatory expertise required to thoroughly evaluate biocompatibility test results of medical devices for suitability across global markets. We provide end-to-end assistance with efficient use of resources, while ensuring that project timelines are met with predictability and diligence. 

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.

Biocompatibility Testing

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.

FAQs: Biocompatibility Testing

  • Why is biocompatibility testing important?

    Biocompatibility testing is part of an overall risk management process to protect humans from potential biological risks stemming from the use of medical devices.

    The evaluation of biocompatibility testing data for a particular device is used as evidence in establishing the device's biological safety.

  • What is device biocompatibility?

    Device biocompatibility is the ability of a medical device or material to perform with an appropriate host response in a specific application [definition per ISO 10993:2018]. More specifically, it is the ability of a medical devices’ materials to perform its intended function, without producing any undesirable effects in the patient, in terms of tissue response given the specific situation.

  • What is ISO 10993 and why is it related to biocompatibility testing?

    The ISO 10993 series are a set of standards for evaluating the biocompatibility of medical devices.

    The first part of the series, ISO 10993-1, is the umbrella standard that gives an overview of what a biological risk evaluation should entail, from risk management to existing data and information about the device and its materials to chemical characterization and biological endpoint testing.

  • Does the TÜV SÜD laboratory perform cytotoxicity, sensitization, and irritation testing?

    The laboratory performs in vitro test methods such as cytotoxicity tests. We partner with dedicated subcontracted laboratories to perform in vivo sensitization, irritation tests, and other biological endpoint tests.

    We are in the process of validating irritation and sensitization tests in vitro to be performed in our lab.

  • What is chemical characterization?

    Chemical characterization is the process of obtaining qualitative and quantitative chemical information, carried out by collecting information about the constituent materials, chemicals, or substances of a medical device.

    The chemical characterization process uses several technologies and evaluation methods, such as microscopic and spectroscopic analysis, x-ray diffraction, and chromatography.

    These techniques provide detailed information about identifying the chemical formulation of a material. Chemical characterization combined with toxicological data can also provide critical information about the nature and extent of potential health, safety, or environmental risks that may occur using such materials throughout the device's life cycle.

  • What is extractable and leachable testing?

    The definition of "extractable" from the ISO 10993-18:2020 is a "substance that is released from a medical device or material of construction when the medical device or material is extracted using laboratory extraction conditions and vehicles." Extraction conditions are often exaggerated compared to the clinical use, e.g., higher temperatures, longer extraction times, etc.

    The definition of "leachable" from the same standard is a "substance that is released from a medical device or material during clinical use." Often leachable studies are performed using conditions that simulate clinical use, e.g., clinical use temperatures and extraction times, etc.

  • What types of biological risk assessments does TÜV SÜD perform?

    The ISO 10993-1:2018 standard requires a structured biological evaluation plan within a risk management process. TÜV SÜD can assist with the biological evaluation plan generation, toxicological risk assessment, and the conclusive biological evaluation report to help your device meet the risk requirements of the standard.

  • How to submit a sample for analysis?

    When you are ready to send a sample, TÜV SÜD will send you a sample submission form to collect information about the device to be tested. After that, we will send the shipping addresses to receive your samples. The samples will be registered and stored under controlled conditions until they are ready to be tested in our laboratory.

  • What accreditations do TÜV SÜD laboratories have?

    Our TÜV SÜD laboratories are fully ISO 17025 accredited. Our US labs are also able to perform testing under Good Laboratory Practices (GLP).

  • What types of microbiological services does TÜV SÜD provide?

    TÜV SÜD offers testing services in bioburden, bacterial endotoxin, reprocessing studies for reusable medical devices, microbial recovery validation studies, biological indicator sterility testing, sterilization validations, etc.

EXPLORE

Biocompatibility Testing of Medical Devices
Infographics

Biocompatibility Testing of Medical Devices

Learn about the biocompatibility, microbiology, and sterility tests that our experts can perform

Read More

Accelerate Your Entry Into New Markets
E-book

Accelerate Entry Into New Markets For Medical Devices

Unrivaled expertise from the global technology leader

Learn More

Download Chemical Characterization of Medical Devices White Paper
White paper

Chemical Characterization of Medical Devices

Discover the specifics of the chemical characterization process, the importance in the overall evaluation of safety.

Learn More

BEP and Biocompatibility
Webinar

ISO 10993 Webinar Series: Biological Evaluation Plan (Part 7 of 7)

Understand the importance of a biological evaluation

Learn More

VIEW ALL RESOURCES

Next Steps

Site Selector