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Nuestras soluciones ofrecen servicios exhaustivos que incluyen consultoría, ensayos y análisis a productos, representación legal, certificación y educación corporativa para todos los niveles del negocio
ENSAYOS INTERCER NUEVA DIRECTIVA EUROPEA DE PRODUCTOS SANITARIOS:
Estudios de Estabilidad (acelerada, shelf life, en uso, etc.)
Ensayo de esterilidad según ISO 11737-2 para la definición, validación y mantenimiento de los procesos de esterilización: validación del método de control y ensayo de esterilidad
Determinación de residuos de esterilización en producto sanitario: Óxido de etileno, propileno y etilenclorhidrina
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing in the risk management process
ISO 10993-2:2006 Biological evaluation of medical devices Part 2: Animal welfare requirements
ISO 10993-3:2014 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-4:2002/Amd 1:2006 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
ISO 10993-6:2007 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
ISO 10993-8:2001 Biological evaluation of medical devices Part 8: Selection of reference materials (withdrawn)
ISO 10993-9:1999 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2006 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials (available in English only)
ISO 10993-13:1998 Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 10993-14:2001 Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics
ISO 10993-15:2000 Biological evaluation of medical devices Part 15: Identification and quantification of degradation products from metals and alloys
ISO 10993-16:1997 Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables
ISO 10993-17:2002 Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances
ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
ISO/TS 10993-19:2006 Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials
ISO/TS 10993-20:2006 Biological evaluation of medical devices Part 20: Principles and methods for immunotoxicology testing of medical devices
ISO/TR 15499:2012 Biological evaluation of medical devices-Guidance on the conduct of biological evaluation within a risk management process