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Chemical testing for medical devices

Performing chemical testing for medical devices as part of biological risk assessment in line with global regulations and directives

ENHANCE MEDICAL DEVICE SAFETY WITH CHEMICAL TESTING

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.

WHAT IS CHEMICAL TESTING AND CHEMICAL CHARACTERISATION FOR MEDICAL DEVICES?

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.

HOW CAN WE HELP YOU?

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. 

WHY CHOOSE US?

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.

OUR SERVICES AT A GLANCE

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 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 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.

YOUR BENEFITS AT A GLANCE

  • Recognised medical device expertise - TÜV SÜD has years of practical knowledge and technical expertise in the testing requirements of medical devices prescribed by various regulators across the globe. By working with TÜV SÜD and our independent testing laboratories, manufacturers can successfully fulfil international regulatory submissions pertinent to their medical devices before placing them on targeted markets around the world. 
  • Outstanding track record in quality and safety - As a trusted partner of choice for high-quality medical device safety solutions, TÜV SÜD adds value to society by protecting patient health from technology-related risks.
  • Active involvement in standards development and implementation – TÜV SÜD actively participates in key standards committees and are involved in standards developments and implementation of all categories of medical devices across the EU, the U.S. and the Asia-Pacific.

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