Biological evaluation within a risk management process / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
;
(6): 280-283, 2007.
Artigo
em Chinês
| WPRIM
| ID: wpr-323268
ABSTRACT
Bio-evaluation within the medical device quality/risk management system is a risk analyzing and assessing process. On the basis of data from characterization of materials, scientific literatures, application history, bio-toxicology testing and so on, weighing the benefit and the risk, bio-evaluation does a conclusion to "take" or "quit" the product design. There is no "zero risk" though "no toxicity" always is the most desirable conclusion in a testing report. The application history data is the most comprehensive among the information available, since no testing system can "clone" the human body. In addition, the capital cost has to be taken into account when bringing the sophisticated testing technologies into the evaluating system. Investigating the #G95-1 of FDA CDRH and the changes of ISO 10993-1, the trend to integrate bio-evaluation into a quality/risk management process can be figured out.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Controle de Qualidade
/
Padrões de Referência
/
Gestão de Riscos
/
Equipamentos e Provisões
Tipo de estudo:
Estudo de etiologia
Idioma:
Chinês
Revista:
Chinese Journal of Medical Instrumentation
Ano de publicação:
2007
Tipo de documento:
Artigo
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