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Título: METROLOGICAL RELIABILITY OF LASER AND INTENSE PULSED LIGHT ELECTROMEDICAL EQUIPMENT
Autor: ALINE MARIA DE CARVALHO DRUMMOND
Colaborador(es): ELISABETH COSTA MONTEIRO - Orientador
PAULA MEDEIROS PROENCA DE GOUVEA - Coorientador
Catalogação: 11/OUT/2007 Língua(s): PORTUGUESE - BRAZIL
Tipo: TEXT Subtipo: THESIS
Notas: [pt] Todos os dados constantes dos documentos são de inteira responsabilidade de seus autores. Os dados utilizados nas descrições dos documentos estão em conformidade com os sistemas da administração da PUC-Rio.
[en] All data contained in the documents are the sole responsibility of the authors. The data used in the descriptions of the documents are in conformity with the systems of the administration of PUC-Rio.
Referência(s): [pt] https://www.maxwell.vrac.puc-rio.br/projetosEspeciais/ETDs/consultas/conteudo.php?strSecao=resultado&nrSeq=10706&idi=1
[en] https://www.maxwell.vrac.puc-rio.br/projetosEspeciais/ETDs/consultas/conteudo.php?strSecao=resultado&nrSeq=10706&idi=2
DOI: https://doi.org/10.17771/PUCRio.acad.10706
Resumo:
Manufacturers must present a Conformity Certificate and register electrical medical products with the National Health Vigilance Agency (ANVISA) before releasing them in the Brazilian market. For medical laser equipment, the mandatory standards are the general safety standard for medical electrical equipment (NBR IEC 601-1) and the particular safety standard for diagnostic and therapeutic laser equipment (NBR IEC 601-2-22). Despite not having a particular standard with safety requirements, medical IPL equipment used for therapeutic applications are also required by ANVISA to comply with NBR IEC 601-1 and NBR IEC 601-2-22. In this thesis, the standards used for the conformity evaluation of laser and intense pulsed light (IPL) electromedical equipment were examined with the purpose of assessing their effectiveness regarding metrological reliability. It was found that, despite the energy measurement requirements in the particular standard NBR IEC 601-2-22, there are no traceable standards for optical energy measurements in Brazil. It was also found that the measurement of other quantities (such as, beam divergence and diameter, pulse duration, pulse repetition rate, among others) should be included in the particular standard. Additionally, it was found that, in order to evaluate safety requirements for medical IPL equipment, the particular standard should include requirements concerning the filters that limit the bandwidth of the radiation. In addition to including the parameters mentioned above, this dissertation also recommends the inclusion of the uncertainty in measurement not only in accompanying documents, but also in the conformity evaluation of the product. Moreover, based on evidences, discussed in this thesis, that the current acceptable error of 20% for the laser power output is extremely high, an in-depth evaluation of the actual acceptable error is recommended. Furthermore, since the particular safety standard (NBR IEC 601-2-22) refers to several clauses in the IEC 60825-1 standard, which has not yet been adopted in Brazil, it is recommended that either the IEC 60825-1 standard be adopted in Brazil, or that the clauses mentioned in NBR IEC 601-2-22 be incorporated to it. Finally, the importance of periodic postsale verifications of electromedical equipment in order to ensure metrological reliability is also discussed.
Descrição: Arquivo:   
COVER, ACKNOWLEDGEMENTS, RESUMO, ABSTRACT, SUMMARY AND LISTS PDF    
CHAPTER 1 PDF    
CHAPTER 2 PDF    
CHAPTER 3 PDF    
CHAPTER 4 PDF    
CHAPTER 5 PDF    
CHAPTER 6 PDF    
CHAPTER 7 PDF    
REFERENCES PDF