Allen Software

In Brazil

A series of laws (ANVISA) regulates this procedure, and defines 14 a gamma of products that are citizens to the system of quality how much to the potential risk the health in users on the basis of norms techniques NBR-IEC, to be applied to the suppliers of medical products and in the fulfilment of the rules of the document ' ' Good the Practical ones of Manufacture of Mdicos&#039 Products; '. In Brazil as well as in diverse countries attention in the certification of medical products if concentrates before the commercialization. The eletromdicos equipment not yet is citizens the conformity evaluation after the commercialization, in use, done exception to some equipment of x-ray and 15 radiodiagnstico . Lasers of low power characterized by not ionizing the electromagnetic radiation, (monochromatic, polarized and coherent) is studied and used clinically it has more than four decades in the treatments neuro-to articulate and of human fabrics and for being capable to induce a fotobiolgico process, or of bioestimulao, not-thermal and not-destructive they do not modify the cellular functions, being one practical one considered for literature, relatively 16 insurance . Amongst the resultant effect of the equipment the laser 17 with low intensities frequently used in therapeutical processes, exists the adverse ones, provoked for the emission of the radiation laser and that they must be observed how much to the security aspects. In them the ocular effect are enclosed, whose protection must guarantee safe levels of radiation absorption. Norm IEC 60825-1 (NBR IEC 601.2.22) suggests security requirements 18 in eletromdicos equipment the laser, including the ocular protection, based in levels of permissible maximum expositions. Biological effect (physiological, biochemists or induced mannering alterations in an organism, fabric or cell) occur when they are detectable changes capable to be measured in a biological system, after the introduction of some types of stimulatons. The comment of a biological effect 19, not necessarily suggests the existence of a biological danger or a harmful effect to the health, therefore it becomes a security risk if the detectable causes to result in damages to the health of the individual.


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