Medical Device Science Introduction医疗设备科学导论.pptVIP

Carmel J Caruana Medical Physics IHC Univ of Malta Medical Devices: Introduction Medical Biophysics In Medical biophysics we will be dealing with the physical principles of biomedical methods and devices and their interactions with the human body - which makes them useful in health care, including patient and user safety aspects and healthcare quality issues. The physical processes in living organisms and the effects of physical factors on them are important as background information. Links Natural sciences (physics, chemistry and biochemistry, biology) Morphological disciplines Physiology and pathological physiology Clinical disciplines (almost all!) Recommended textbook How to study? Studying medical biophysics, there is no problem with the amount of knowledge which is necessary to master, but with understanding the physical principles and their application. Memorisation without understanding will not be sufficient to have a success at the exam. Medical Devices : Introduction What is a Medical Device? “any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used on human beings for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, or alleviation of or compensation for an injury or handicap, investigation, replacement or modification of the anatomy or of 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.” (MDD Article 1(2a)) The EU Medical Device Directives The Medical Devices Directive (MDD) (93/42/EEC, OJ L169 p0001-0043) : from bandages, tongue depressors, thermometers to contact lenses, stethoscopes, splints, first-aid kits, breathalysers, heart valves and im