Emerging approach to the biological evaluation of medical devices
Global Medical Device Regulations continue to evolve, as devices become more complex and sophisticated.
ISO Technical Committee 194 is currently revising the ISO 10993 series of standard, in particular ISO 10993-1 “Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process” and ISO 10993-18 “Biological evalua
tion of medical devices -- Part 18: Chemical characterization of materials”.
The approach to the biological evaluation is changing. The old “check list approach” is shifting towards an evaluation base
d upon review of relevant established scientific data, physio-chemical characterization and in vitro testing, with in vivo testing only being carried out to fill gaps in our understanding.
The biological evaluation of any material or medical device intended for use in humans shall form part of a structured biological evaluation programmed within a risk management process in accordance with ISO 14971 “Medical devices -- Application of risk management to medical devices”.
The information required in a biological evaluation, shall be determined by assessing the information already available in light of the biological evaluation required, enabling the categorization of devices and a gap analysis to facilitate the selection of appropriate tests.
All device types (all device categories, with all types of contact, and all durations of contact) will require a chemical characterization as a prerequisite for the risk assessment. The data coming from the chemical characterization should be toxicologically assessed to elucidate the need for further tests to address the relevant biological endpoints for the device under evaluation.
Testing is usually not necessary when sufficient information is already available to perform a risk assessment of the material and/or the medical device.
Eurofins Medical Device Testing Italy in partnership with Li-Med is pleased to introduce a dedicated Workshop that will take place on November 16th, 2017 at Leonardo City Tower Tel Aviv Hotel.
This Workshop is designed to provide a solid and clear understanding of key topics, critical aspects and regulatory framework within biocompatibility. Focusing on the latest updates of ISO 10993, by attending, participants will gain deep insight on the impact that upcoming changes will reflect on the biological evaluation process. Benefit from the strong expert advice on how to overcome challenges and implement successfully your biocompatibility testing strategy.
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