Chemical testing of medical devices

Medical devices used for diagnosis, surgeries and other medical procedures typically go through stringent biocompatibility testing according to global regulatory requirements for patient safety based on chemical exposure to patients. An independent testing and certification body such as TÜV SÜD assesses the biological risks involved when the device is in contact with a patient.

Chemical characterisation is a key category of chemical testing involved in biological risk assessment. Chemical characterisation is the process of identifying, characterising and comprehending the chemicals used in the manufacturing, sterilisation, and even the packaging of medical devices. These chemicals are often referred to as extractables (i.e. can be extracted from the device) and leachables (chemicals that passively leave the device under normal conditions of use). TÜV SÜD performs extractables-leachables studies to analyze these chemical components to create a chemical profile. We follow this with a toxicological risk assessment of the chemical profile to support patient safety

Chemical testing ensures that the medical device complies with directives on the use of raw materials and chemicals, for example as softeners, additives and cleaning agents, throughout the manufacturing process. Biocompatibility standards require that all medical devices be chemically characterised based on chemical information. This ranges from low-risk devices such as disinfectants and medical spatulas to high-risk devices such as implants and cardiac pacemakers.

By analysing the chemical substances that make their way from the device to a patient, manufacturers can predict potential toxicities and mitigate them. This helps manufacturers meet global regulatory standards more effectively and ensure patient health and safety.

TÜV SÜD is one of the leading providers of medical device testing services. Our years of practical knowledge and technical expertise make us a trusted partner in the industry. Our team of experts can help manufacturers address product risks so they can deliver quality medical devices that perform intended functions while protecting patient health and safety. 

We offer medical device manufacturers high-quality and cost-effective chemical testing services and product evaluation solutions that meet global regulations. This testing strategy allows manufacturers to target all their desired markets without hassle.  

We help address manufacturers’ needs in understanding the chemical characterisation process and making sense of medical devices testing outcomes. This helps manufacturers fulfil regulatory submissions with precision. 

Our global network of medical device experts comprises scientists, toxicologists, physicians, and doctors. This underpins our advanced knowledge of device testing and regulatory compliance. We actively participate in key standards committees and are involved in standards development. We keep track of regulatory changes and ensure that our testing approach consistently complies with worldwide requirements, ensuring state of the art testing for manufacturers.

TÜV SÜD upholds the testing standards required by the International Organisation for Standardisation (ISO) to help manufacturers achieve global acceptance. We provide chemical testing services as per ISO 10993. 

• Chemical characterisation of medical device materials - ISO 10993-18 – Also known as extractables and leachables testing, chemical characterisation of medical devices identifies 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. 
• Toxicological Risk Assessment - ISO 10993-17 – Alongside an analytical chemical characterisation 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.