Evaluation of medical equipment based on wave phenomena according to technicl standards NBR IEC 60601 series. / Avaliação de equipamentos eletromédicos que operam por meio de fenômenos ondulatórios segundo a série de normas técnicas NBR IEC 60601.

AUTOR(ES)
DATA DE PUBLICAÇÃO

2009

RESUMO

Wave phenomena have been widely used in medicine and many medical devices that use these phenomena are designed both for therapeutical and diagnosis purposes. Microwave equipment for therapy, short-wave equipment for therapy, LASER equipment for therapy, ultrasound equipment for therapy and for diagnosis and phototherapy equipment are examples of medical products that use wave phenomena. The certification of these products is compulsory for them to be marketed in Brazil and the Technical Standards ABNT NBR IEC 60601 series contains the prescriptions of safety and essential performance that medical equipment must meet. An important stage in the certification of medical equipment is the verification of compliance tests performed in Test Laboratories accredited by INMETRO. This research provides a description of commonly used applications of wave phenomena in therapy and diagnosis in the medical field, describing also the limits considered safe for the patients exposure to electromagnetic fields and acoustic as well as the limits for unwanted exposure to people close to medical equipment. It also describes the methods of measurement commonly used to measure the wave phenomena, presents measurement processes that were created using some of these methods and presents the results of the research and selection of measurement instruments that were acquired for the tests prescribed by the Technical Standards NBR IEC 60601 series. It also presents the results of the measurements carried out of commercial eletromedical equipments used to validate the testing procedures that were developed using the measurement instruments acquired. This research could certainly be used as reference for Testing Laboratories that have similar interests in obtaining a technical competence and infrastructure for the tests discussed, as well as companies that produce medical equipment based on the wave phenomena in order to improve their products.

ASSUNTO(S)

medical equipment segurança de equipamentos normas de segurança e desempenho essencial technical standards abnt nbr iec 60601 series testing laboratory equipamentos eletromédicos wave phenomena

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