Chemical testing (analytical testing) for medical devices encompasses the process of identifying, characterizing and comprehending the chemicals used in their 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).
To determine the types and amounts of volatile, semi-volatile and non-volatile organic as well as inorganic impurities that migrate from a device, the need for chemical characterisation of materials based on ISO 10993-18 is necessary - Also known as the extractables and leachables test. Further, a toxicological risk assessment (TRA) also helps to establish the device’s safety limits of these impurities.
Join our complimentary webinar, as our expert practitioner delves into these aspects and further explains in depth quantities of extractables & leachables that migrate from a medical device when it is used and how associated risks based on their exposure may also be quantified.
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Who should attend?
Mr. Asif A
Manager - Chemical Lab, Healthcare and Medical Devices, TÜV SÜD
Mr. Asif A serves as a Manager - Chemical Lab, at the Biological Safety, Reusable Device & Lot Release (BRL) lab for the Healthcare and Medical Devices division of TÜV SÜD South Asia. His industry rich experience of over 11 years covers multiple positions across nutraceutical, pharmaceutical and medical device testing labs in India.
Mr. Asif has previously worked in the R&D spectrum and comes with widespread knowledge in the field of chemical analysis and regulated bioanalysis.
With a degree in biochemistry, Mr. Asif oversees chemical characterization studies for medical devices and is in-charge of the chemical lab at the Healthcare and Medical Devices division of TÜV SÜD’s Bengaluru Campus in India.