![]() ![]() (c) an argumentation as to why possible substance and/ or material substitutes or design changes, are inappropriate in relation to maintaining the functionality, performance and the benefit-risk ratios of the product. (b) An analysis of possible alternative substances, materials or designs (a) An analysis and estimation of potential patient or user exposure to the substance He explains that the European Medical Device Regulation opens up for the use if a justification for the presence of can be made based upon: – The door for cobalt-chromium alloys is not completely closed, Dahl says. ![]() ![]() prostheses, cardiovascular implant, surgical instruments, syringes, needles, and catheters. Cobalt-chromium alloys used in dentistry contain around 60 % cobalt.Ī ban on cobalt-chromium alloys has great impact on dentistry but also on medical side, as a vast number of medical devices and instruments are made from such alloys i.e. The issue was discussed at a symposium at Riskstämman in Gothenburg, in November, where Dahl lectured.Īccording to the European Medical Device Regulation, medical and dental devices cannot contain more than 0.1 % of a CMR substance. The use of cobalt in dental devices as crowns, bridges and removable partial prosthesis have now raised concern as cobalt is classified as a CMR (Carcinogenic, Mutagenic, toxic to Reproduction) substance, says Jon E. ![]()
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