Performing chemical testing for medical devices as part of biological risk assessment in line with global regulations and directives
Medical devices used for diagnosis, surgeries and other medical procedures typically go through stringent biocompatibility testing according to global regulatory requirements to assess the biological risks involved when the device is in contact with a patient. Among the tests involved, chemical testing plays an important role in the biological risk assessment of the device. It is required to ensure that the medical device complies with directives on the use of raw materials and chemicals as e.g. softeners, additives and cleaning agents throughout the manufacturing process.
Chemical testing (analytical testing) for medical devices refers to the process of identifying, characterising and comprehending the chemicals used in the manufacturing process. These chemicals are often referred to as extractables (chemicals that can be extracted from the device through manipulation) and leachables (chemicals that passively leave the device under normal conditions of use). Combined extractables leachables studies are performed to study the chemical components and are therefore called chemical characterisation which is followed by a toxicological risk assessment.
According to biocompatibility standards, it is a requirement for all medical devices to obtain chemical information which leads to chemical characterisation for most of the medical devices. This ranges from low-risk devices such as disinfectants and medical spatulas to high-risk devices, including 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 offers medical device manufacturers high-quality and cost-effective chemical testing services and product evaluation solutions to meet various regulations and directives around the world. Our global network of medical device experts delivers rich technical expertise in chemical characterisation processes. We help address manufacturers’ needs in comprehending the chemical characterisation process and in making sense of test outcomes against the requirements across global markets so that they can fulfil regulatory submissions with precision.
TÜV SÜD is one of the leading providers for a range of medical device testing services. We help manufacturers address various categories of product risks so that they can deliver quality devices to the medical field that perform intended functions while protecting the safety and health of patients. Our advanced technical knowledge in device testing and regulatory compliance is underpinned by our global network of medical health and services professionals, comprising scientists, physicians and doctors. We keep track of regulatory changes and ensure that worldwide compliance with medical device regulations is consistently met.
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.
Overcoming hazards in connected healthcare
Ensure the continued recognition of previously approved medical devices that incorporate Tyvek®.
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