Download the exclusive whitepaper
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.
To download simply log in or register for an Informa Connect account, which will give you access to all our exclusive premium content. Have any questions or interested in sponsoring future content? Email email@example.com.
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.