Get started with TÜV SÜD
Request our services for your medical device toxicology needs.
What is toxicological risk assessment for medical devices?
Toxicological risk assessment (TRA) is a comprehensive safety evaluation of a product based on its composition and intended use. This detailed scientific assessment report consists of all the available information about materials used in medical devices and the possible hazards from those ingredients. Typically, the TRA assesses the risk from chemical and/or elemental constituents from a finished, final medical device on which a 10993-18-compliant chemical characterisation study has been performed. ISO 10993 is a series of standards for evaluating the biocompatibility of medical devices to manage biological risk. ISO 10993-17 and ISO/TS 21726 specifically discuss the toxicological risk assessment process and the determination of allowable limits for substances.
Why toxicological risk assessment for medical devices is important
One of the greatest challenges in the chemical characterisation process for medical devices is properly assessing the biological and toxicological risks associated with extractables and leachables that can compromise patient safety.
Risks associated with exposure to hazardous substances are managed by identifying the substances, quantifying the risks, and performing toxicological assessment.
This risk assessment is an important and necessary part of chemical characterisation and biocompatibility studies because it establishes allowable limits for extractable/leachable substances.
Risks associated with exposure to hazardous substances are managed by identifying the substances, quantifying the risks, and performing toxicological assessment.
This risk assessment is an important and necessary part of chemical characterisation and biocompatibility studies because it establishes allowable limits for extractable/leachable substances.
How TÜV SÜD can help you with toxicological risk assessment for medical devices
By helping to address medical manufacturers’ needs in determining and understanding the chemical characterisation process and testing outcomes, TÜV SÜD acts as an instrumental partner for organisations of all sizes.
We are actively involved in standards development and implementation and are a part of several standards-setting committees. This helps us anticipate technological challenges and advise businesses.
We are actively involved in standards development and implementation and are a part of several standards-setting committees. This helps us anticipate technological challenges and advise businesses.
What our service includes
Our services include:
- Toxicological Risk Assessment - ISO 10993-17 – Alongside an analytical chemical characterisation study, regulatory bodies require a toxicological assessment of extractables and leachables for certain products, to establish the device’s safety limits of these impurities.
- Chemical Characterisation of Materials - ISO 10993-18 – Also known as the extractables and leachables test, the analytical chemical characterisation of medical devices looks at the types and amounts of volatile, semi-volatile and non-volatile organic as well as inorganic impurities. This chemical profile evaluates the overall risk posed by the device to patients.
- Cytotoxicity - ISO 10993-5 – Cytotoxicity tests evaluate the level of cell damage or cell death that a substance can cause, so that substances that are cytotoxic (i.e. causing cell damage or death) can be removed from a product.
- Genotoxicity - ISO 10993-3 & FDA – Genotoxicity tests identify the presence of toxins that can impact the genetic material of cells.
- Hemocompatibility - ISO 10993-4 & ASTM standard – 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 potential of medical devices, materials and extracts to cause irritation to the skin. This can be done through in vivo and in vitro test procedures.
- Sensitisation - ISO 10993-10 – Sensitisation 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 standard – 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.
Start your journey with us.
