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Biomateriales - Biocompatibilidad

Biomateriales - Biocompatibilidad. Biomaterial: Material en contacto con el tejido biológico

damian-gaines
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Biomateriales - Biocompatibilidad

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  1. Biomateriales - Biocompatibilidad • Biomaterial:Material en contacto con el tejido biológico • Biocompatibilidad: Cualidad que tiene un biomaterial de no tener efecto tóxico o dañino en un sistema fisiológico. Es una interacción química y física entre el material y el tejido cuya respuesta reproducible debe ser descripta y caracterizada.

  2. BIOMATERIALES Y BIOCOMPATIBILIDAD Dr. Carlos Oldani Dra. Nancy Salvatierra Ing. Laura Reyna

  3. Biomateriales – BiocompatibilidadDesarrollos • Aleaciones de Ti porosas: Obtener por pulvimetalurgia aleaciones de porosidad controlada. Ventajas: • Disminución del módulo de elasticidad (E) para asimilarlo al comportamiento del hueso y disminución del stress-shielding (osteopenia asociada al uso de implantes protésicos) • Mejora en la posibilidad de oseointegración

  4. Biomateriales – BiocompatibilidadDesarrollos • Dispositivos médicos utilizando alambres de Nitinol: Aleación Ni-Ti con memoria de forma • Desarrollo de músculos artificiales • Desarrollo de recuperador de trombos venosos

  5. Laboratorio de Biocompatibilidad Universidad Nacional de Córdoba • Laboratorio Multidisciplinario • Caracterización Física – Ensayos Mecánicos • Caracterización Química • Evaluación Biológica • Citotoxicidad • Sensitización • Irritabilidad • Implantación

  6. Evaluación Biológica de dispositivos médicos Aspectos a considerar • Material utilizado en el dispositivo • Tipo de contacto con el cuerpo • Dispositivos de contacto superficial • Dispositivos de comunicación externa • Dispositivos implantables • Duración del contacto • Limitado (< 24 hs) • Prolongado ( >24 hs y < 30 días) • Permante (> 30 días)

  7. Matriz para evaluación biológica

  8. Matriz para evaluación biológica

  9. Extracto de Norma IEC 60601 – 1 (2005) 11.7 Biocompatibility of ME EQUIPMENT and ME SYSTEMS (Pag. 333) ME EQUIPMENT, ME SYSTEM and their parts of ACCESSORIES intended to come into direct or indirect contact with biological tissues, celles or body fluids shall be assessed and documented according to the guidance given en the ISO 10993 series of standards.

  10. NORMA ISO 10993 Hoja 1 de 3 • Parte 1: Evaluation and testing (2003) • Parte 2: Animal welfare requirements (2006) • Parte 3: Test for genotoxicity, carcinogenicity and reproductive toxicity (2003) • Parte 4: Selection for tests for interactions with blood (2002) • Parte 5: Test for in vitro cytotoxicity (1999) • Parte 6: Test for local effects after implantation (2007) • Parte 7: Ethylene oxide sterilization residuals (2008) • Parte 8: Selection and qualification of reference materials for biological tests (2000)

  11. NORMA ISO 10993 Hoja 2 de 3 • Parte 9: Framework for identification and quantification of potential degradation products(1999) • Parte 10: Test for irritation and delayed-type hypersensivity (2002 / Amd 1:2006) • Parte 11: Test for systemic toxicity (2006) • Parte 12: Sample preparation and reference materials (2007) • Parte 13: Identification and quantification of degradation products from polymeric medical devices (1998) • Parte 14: Identification and quantification of degradation products from ceramics (2001) • Parte 15: Identification and quantification of degradation products from metals and alloys (2000)

  12. NORMA ISO 10993 Hoja 3 de 3 • Parte 16: Toxicokinetic Study Design for Degradation Products and Leachables (1997 R2003) • Parte 17: Establishment of allowable limits for leachable substances (2002) • Parte 18: Chemical characterization of materials (2005) • Parte 19: Physico-chemical, mechanical and morphological characterizationm (2006) • Parte 20: Principles and methods for immunotoxicology testing of medical devices (2006)

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