Título: | METROLOGICAL RELIABILITY OF LASER AND INTENSE PULSED LIGHT ELECTROMEDICAL EQUIPMENT | ||||||||||||||||||||||||||||||||||||||||||||
Autor: |
ALINE MARIA DE CARVALHO DRUMMOND |
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Colaborador(es): |
ELISABETH COSTA MONTEIRO - Orientador PAULA MEDEIROS PROENCA DE GOUVEA - Coorientador |
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Catalogação: | 11/OUT/2007 | Língua(s): | PORTUGUESE - BRAZIL |
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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. |
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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 |
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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.
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