toxicological risk assessment

Toxicological Risk Assessment of Medical Devices

Learn the specifics of the toxicological risk assessment process in line with ISO 10993

Learn the specifics of the toxicological risk assessment process in line with ISO 10993


One of the greatest challenges in the chemical characterization process for medical devices is properly assessing the biological and toxicological risks associated with extractables or chemical residues that can compromise patient safety.

Risks associated with exposure to hazardous leachable substances are managed by identifying the leachable substances, quantifying the associated risks, and limiting exposure within tolerable levels.


Toxicological risk assessment (TRA) is a comprehensive safety evaluation of a product based on its composition, materials, and intended uses. This detailed, scientific assessment report consists of all the available information and data regarding a specific ingredient within the context of the nature of the medical device, including its dosage or concentration, and the specific exposure scenario.

Toxicological Risk Assessment is researched based evaluation comprising of following activities

  1. Hazard identification and data evaluation.
  2. Exposure assessment
  3. Dose response assessment
  4. Risk characterisation


This risk assessment is an important and necessary part of chemical characterization and biocompatibility studies because it establishes allowable limits for extractable/leachable substances.

ISO 10993 is a series of standards for evaluating the biocompatibility of medical devices to manage biological risk. ISO 10993-17, ISO/TS 21726 specifically discusses the determination of allowable limits for substances leachable from medical devices based on a toxicological risk assessment of medical device constituents.


A toxicological risk assessment must be performed by a qualified toxicologist, involving an extensive review of all available scientific resources in relation to the toxicology of the leachable and/or extractable. In situations where there is insufficient literature data, studies must be conducted in order to complete the risk assessment.

TÜV SÜD provides global, high-quality, and expert chemical testing services and product evaluation solutions to meet various international regulations and directives all around the world, including ISO 10993-17.

By helping to address medical manufacturers’ needs in determining and understanding the chemical characterization process and testing outcomes, TÜV SÜD acts as an instrumental partner in ensuring regulatory compliance for organizations of all sizes. We provide end-to-end assistance with efficient use of resources, while ensuring that project timelines are met with predictability and diligence.


TÜV SÜD offers complete biocompatibility testing solutions for medical devices through our state-of-the-art laboratories and expert team of medical doctors, engineers, and toxicologists located all across the globe.

  • Toxicological Risk Assessment - ISO 10993-17: Alongside an analytical chemical characterization study, certain regulatory bodies require a toxicological assessment of extractables and leachables, for certain products, to establish the device’s safety limits of these impurities
  • Chemical Characterization of Materials - ISO 10993-18: Also known as the extractables and leachables test, the analytical chemical characterization of medical devices looks at the types and amounts of volatile, semi-volatile and non-volatile organic as well as inorganic impurities that migrate from a device during use. This chemical profile evaluates the overall risk posed by the device to patients.
  • 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.
  • 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 10993-23: 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.


  • Globally- Recognized Medical Device Expertise - TÜV SÜD is a trusted partner with dedicated teams of over 700 global experts who are committed to helping your organization manage risks and bring the safest medical device possible to the market. With a Regulatory Foreign Affairs and Clinical Centre of Excellence, TÜV SÜD is recognized by regulatory authorities around the world for its extensive experience with all types of medical devices.
  • Risk Management Expertise - Our experts have extensive experience in every aspect of risk management systems for medical device manufacturers in accordance with ISO 10993-17 and ISO 14971 and conduct thousands of in-depth risk management audits each year.
  • Active Involvement in Standards Development and Implementation - TÜV SÜD takes a proactive approach to anticipate technological developments and facilitate change. To define the next standards in safety, security and sustainability, our experts sit in standard-setting committees and consortiums. With these initiatives, we go beyond regulatory compliance to inspire trust in a physical and digital world.
  • Single Source Solution - TÜV SÜD offers testing services for major medical device markets according to international standards and regulations.
  • Other Testing and Certification Services - In addition to biocompatibility assessments required for medical devices, TÜV SÜD can also provide compliance testing for medical devices in accordance with other relevant regulations and standards.


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