ISO 10993-5:2009 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion.
What is the ISO 10993 used for?
The ISO 10993 set entails a series of standards for evaluating the biocompatibility of medical devices to manage biological risk. These documents were preceded by the Tripartite agreement and is a part of the international harmonisation of the safe use evaluation of medical devices.
What are external communicating device?
External Communicating Device: Tissue/Bone/Dentin Tissue includes tissue fluids and subcutaneous spaces. Other endpoints you may need to address: Reproductive and development toxicity, degradation information.18 Mar 2021
What classifies something as a medical device?
In general terms, a medical device is any device that is intended for medical purposes. These devices help healthcare providers to diagnose and treat patients, helping patients to overcome illness or disease and improving quality of life.
What is considered a nanoparticle?
nanoparticle, n—in nanotechnology, a sub-classification of ultrafine particle with lengths in two or three dimensions greater than 0.001 micrometer (1 nanometer) and smaller than about 0.1 micrometer (100 nanometers) and which may or may not exhibit a size-related intensive property.
What is a medical use for nanoparticles?
Researchers today are able to encapsulate medicine in nanoparticles, the size of viruses. The nanoparticles are effective for drug delivery—the delivery of the medicine to the body—because they can very precisely find diseased cells and carry the medicine to them.1 Jan 2013