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ARTIFICIAL ORGAN AND PROSTHESIS- any instrument, apparatus, appliance, software, material or another article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for: • diagnosis, prevention, monitoring, treatment or alleviation of disease, • Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, • Investigation, replacement or modification of the anatomy or a physiological process, • Control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means; Devices that interact with the body directly, i.e. have an interface with the biological environment A biomaterial is a systemical
Typology: Summaries
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Artificial Organs and Prosthesis 08/03/
2 some definitions… According to Article 1 of Council Directive 93/42/EEC ‘medical device’ means: any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
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A biomaterial is a systemically, pharmacologically inert substance designed for implantation within or incorporation with a living system. Annual International Biomaterials Symposium 1974 Any substance (other than a drug) or combination of substances, synthetic or natural in origin, which can be used for any period of time, as a whole or as a part of a system which treats , augments or replaces any tissue, organ or function of the body. Consensus Development Conference on the Clinical Applications of Biomaterials 1982 Non-living substance, used in the manufacture of a medical device that has interfaces with a living tissue. European Society of Biomaterials 1986 A biomaterial is any substance that has been engineered to interact with biological systems for a medical purpose - either a therapeutic (treat, augment, repair or replace a tissue function of the body) or a diagnostic one Definitions in Biomaterials, Proceedings of a Consensus Conference of the European Society for Biomaterials 2004
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Some historical examples
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Some historical examples
In many circumstances, materials properties do not affect cell behaviour directly, but rather the adsorption of proteins present in the environment