NTC-ISO 16142-2:2018

DISPOSITIVOS MÉDICOS. PRINCIPIOS ESENCIALES DE SEGURIDAD Y DESEMPEÑO RECONOCIDOS. PARTE 2. PRINCIPIOS ESENCIALES GENERALES Y PRINCIPIOS ESENCIALES ESPECÍFICOS ADICIONALES PARA TODOS LOS DISPOSITIVOS MÉDICOS IVD Y ORIENTACIÓN PARA LA SELECCIÓN DE NORMAS

MEDICAL DEVICES. RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES. PART 2: PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS

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Este documento, que incluye los principios esenciales de seguridad y desempeño, identifica las normas y guías significativas que se pueden usar en la evaluación de conformidad de un dispositivo médico de acuerdo con principios esenciales reconocidos que, cuando se cumplen, indican que un dispositivo médico es seguro y tiene el desempeño previsto. Este documento identifica y describe los seis principios generales esenciales de seguridad y desempeño (véase la Tabla B.1) que se aplican a todos los dispositivos médicos, incluidos los dispositivos médicos IVD (diagnóstico in vitro).

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Referencias de normas

  • ISO 16269-7:2001 Statistical interpretation of data-- Part 7: Median -- Estimation and confidence intervals
  • ISO 11140-3:2007/Cor 1:2007 ISO 11140-3:2007/Cor 1:2007
  • ISO 17593:2007 Clinical laboratory testing and in vitro medical devices -- Requirements for in vitro monitoring sys
  • ISO 14644-5:2004 Cleanrooms and associated controlled environments-- Part 5: Operations
  • ISO 2859-2:1985 Sampling procedures for inspection by attributes-- Part 2: Sampling plans indexed by limiting qualit
  • ISO 18153:2003 In vitro diagnostic medical devices -- Measurement of quantities in biological samples -- Metrologic
  • ISO 2859-3:2005 Sampling procedures for inspection by attributes-- Part 3: Skip-lot sampling procedures
  • ISO 11140-3:2007 Sterilization of health care products -- Chemical indicators-- Part 3: Class 2 indicator systems for
  • ISO 11140-4:2007 Sterilization of health care products -- Chemical indicators-- Part 4: Class 2 indicators as an alte
  • ISO 3951-5:2006 Sampling procedures for inspection by variables-- Part 5: Sequential sampling plans indexed by accep
  • ISO 13408-3:2006 Aseptic processing of health care products-- Part 3: Lyophilization
  • ISO 3951-3:2007 Sampling procedures for inspection by variables-- Part 3: Double sampling schemes indexed by accepta
  • ISO 14644-4:2001 Cleanrooms and associated controlled environments-- Part 4: Design, construction and start-up
  • ISO 2859-5:2005 Sampling procedures for inspection by attributes-- Part 5: System of sequential sampling plans index
  • ISO 17511:2003 In vitro diagnostic medical devices -- Measurement of quantities in biological samples -- Metrologi
  • ISO 14698-2:2003/Cor 1:2004 ISO 14698-2:2003/Cor 1:2004
  • ISO 13408-6:2005 Aseptic processing of health care products-- Part 6: Isolator systems
  • ISO 11137-1:2006 Sterilization of health care products -- Radiation-- Part 1: Requirements for development, validatio
  • ISO 17665-1:2006 Sterilization of health care products -- Moist heat-- Part 1: Requirements for the development, vali
  • ISO 13408-4:2005 Aseptic processing of health care products-- Part 4: Clean-in-place technologies
  • ISO 11737-1:2006 Cor 1:2007 ISO 11737-1:2006/Cor 1:2007
  • ISO 14644-7:2004 Cleanrooms and associated controlled environments-- Part 7: Separative devices (clean air hoods, glo
  • ISO 11140-5:2007 Sterilization of health care products -- Chemical indicators-- Part 5: Class 2 indicators for Bowie
  • ISO 14698-2:2003 Cleanrooms and associated controlled environments -- Biocontamination control-- Part 2: Evaluation a
  • ISO 14698-1:2003 Cleanrooms and associated controlled environments -- Biocontamination control-- Part 1: General prin
  • ISO 2859-1:1999 Sampling procedures for inspection by attributes-- Part 1: Sampling schemes indexed by acceptance qu
  • ISO 13408-5:2006 Aseptic processing of health care products-- Part 5: Sterilization in place
  • ISO 2859-4:2002 Sampling procedures for inspection by attributes-- Part 4: Procedures for assessment of declared qua
  • ISO 16269-8:2004 Statistical interpretation of data-- Part 8: Determination of prediction intervals
  • ISO 13408-1:2008 Aseptic processing of health care products-- Part 1: General requirements
  • ISO 15882:2008 Sterilization of health care products -- Chemical indicators -- Guidance for selection, use and inte
  • ISO/TS 17665-2:2009 Sterilization of health care products -- Moist heat-- Part 2: Guidance on the application of ISO 176
  • ISO 15193:2009 In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin --
  • ISO 15194:2009 In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin --
  • ISO 14937:2009 Sterilization of health care products -- General requirements for characterization of a sterilizing
  • ISO 18113-1:2009 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling)-- Part 1
  • ISO 18113-2:2009 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling)-- Part 2
  • ISO 18113-3:2009 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling)-- Part 3
  • ISO 18113-4:2009 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling)-- Part 4
  • ISO 18113-5:2009 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling)-- Part 5
  • ISO 16269-4:2010 Statistical interpretation of data-- Part 4: Detection and treatment of outliers
  • ISO 3951-4:2011 Sampling procedures for inspection by variables-- Part 4: Procedures for assessment of declared qual
  • ISO 13408-7:2012 Aseptic processing of health care products-- Part 7: Alternative processes for medical devices and c
  • ISO 14644-9:2012 Cleanrooms and associated controlled environments-- Part 9: Classification of surface cleanliness by
  • ISO 14644-8:2013 Cleanrooms and associated controlled environments-- Part 8: Classification of air cleanliness by che
  • ISO 14644-10:2013 Cleanrooms and associated controlled environments-- Part 10: Classification of surface cleanliness b
  • ISO 13408-6:2005/Amd 1:2013 ISO 13408-6:2005/Amd 1:2013
  • ISO 13408-1:2008/Amd 1:2013 ISO 13408-1:2008/Amd 1:2013
  • ISO/TS 13004:2013 Sterilization of health care products -- Radiation -- Substantiation of selected sterilization dose:
  • ISO/TS 17665-3:2013 Sterilization of health care products -- Moist heat-- Part 3: Guidance on the designation of a medic
  • ISO 15197:2013 In vitro diagnostic test systems -- Requirements for blood-glucose monitoring systems for self-testi
  • ISO 11137-2:2013 Sterilization of health care products -- Radiation-- Part 2: Establishing the sterilization dose
  • ISO 11137-1:2006/Amd 1:2013 ISO 11137-1:2006/Amd 1:2013
  • ISO 3951-1:2013 Sampling procedures for inspection by variables-- Part 1: Specification for single sampling plans in
  • ISO 3951-2:2013 Sampling procedures for inspection by variables-- Part 2: General specification for single sampling
  • ISO 16269-6:2014 Statistical interpretation of data-- Part 6: Determination of statistical tolerance intervals
  • ISO 11135:2014 Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validat
  • ISO 11607-1:2006 Amd 1:2014 ISO 11607-1:2006/Amd 1:2014
  • ISO 11607-2:2006 Amd 1:2014 ISO 11607-2:2006/Amd 1:2014
  • ISO 11140-1:2014 Sterilization of health care products -- Chemical indicators-- Part 1: General requirements
  • ISO 14644-2:2015 Cleanrooms and associated controlled environments-- Part 2: Monitoring to provide evidence of cleanr
  • ISO 14644-1:2015 Cleanrooms and associated controlled environments-- Part 1: Classification of air cleanliness by par
  • ISO 13485:2016 Medical devices -- Quality management systems -- Requirements for regulatory purposes
  • ISO 14644-14:2016 Cleanrooms and associated controlled environments-- Part 14: Assessment of suitability for use of eq
  • ISO 15223-1:2016 Medical devices -- Symbols to be used with medical device labels, labelling and information to be su
  • ISO 11138-1:2017 Sterilization of health care products -- Biological indicators-- Part 1: General requirements
  • ISO 11138-2:2017 Sterilization of health care products -- Biological indicators-- Part 2: Biological indicators for e
  • ISO 11138-3:2017 Sterilization of health care products -- Biological indicators-- Part 3: Biological indicators for m
  • ISO 11138-4:2017 Sterilization of health care products -- Biological indicators-- Part 4: Biological indicators for d
  • ISO 11138-5:2017 Sterilization of health care products -- Biological indicators-- Part 5: Biological indicators for l
  • ISO 11137-3:2017 Sterilization of health care products -- Radiation-- Part 3: Guidance on dosimetric aspects of devel
  • ISO 14644-13:2017 Cleanrooms and associated controlled environments-- Part 13: Cleaning of surfaces to achieve defined
  • ISO 14644-15:2017 Cleanrooms and associated controlled environments-- Part 15: Assessment of suitability for use of eq
  • ISO 11737-1:2018 Sterilization of health care products -- Microbiological methods-- Part 1: Determination of a popula
  • ISO 13408-2:2018 Aseptic processing of health care products-- Part 2: Sterilizing filtration
  • ISO 11137-1:2006/Amd 2:2018 Revision to 4.3.4 and 11.2
  • ASTM F2027 ASTM F2027
  • ASTM F2761 ASTM F2761

    Equivalencias de normas

  • ISO 16142-2:2017 Medical devices -- Recognized essential principles of safety and performance of medical devices-- Pa
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