As originally asked by Siva Murugan.

Please let me know your thoughts regarding Biocompatibility testing approach. Whether you go for box ticking exercise as per ISO 10993 or do a Biological Safety Assessment and then to Biocompatibility testing.

Steve Weisner
President & CEO of Nihon Kohden Innovation Center at Nihon Kohden
I would think that the answer depends on what you are testing. We have a non-invasive sensor with a non-sterile disposable that holds the sensor and adheres to the skin. We make sure all disposable subcomponents do not contain hazardous material (self reporting by the vendor). Then we have a licensed agency conduct 10993-5 cytoxicity, 10993-10 irritation and 10993-10 hypersensitivity testing.