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Regulatory Affairs, Medical Devices

Understanding how ISO 10993-17 and ISO 10993-18 connect - WHITEPAPER


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Risk assessment is a key component in the approval process for a new medical device. The International Organization for Standardization (ISO) 10993 series of standards is recognized by
regulatory bodies throughout the world and applies when a medical device comes into contact with the body directly or indirectly. Both ISO 10993-17/18 should be considered in the context of the ISO 10993-1: evaluation and testing within a risk management process. ISO 10993 guides the assessment of medical devices on tissues in a general way. For a complete biological safety evaluation, it classifies medical devices according to the nature and duration of their use and indicates the data sets that are relevant.

This whitepaper discusses ISO 10993-17/18, how they relate, and considerations for industry.

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This piece represents the views of the author and not necessarily the views of Informa Connect Life Sciences or the Biocompatibility for Medical Devices conference series.

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