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  • UNI EN ISO 10993-1 : 2010

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS

    Available format(s): 

    Superseded date:  25-08-2022

    Language(s): 

    Published date:  31-12-2009

    Publisher:  Ente Nazionale Italiano di Unificazione (UNI)

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    Table of Contents - (Show below) - (Hide below)

    PREMESSA
    INTRODUZIONE
    1 SCOPO E CAMPO DI APPLICAZIONE
    2 RIFERIMENTI NORMATIVI
    3 TERMINI E DEFINIZIONI
    4 PRINCIPI GENERALI DI APPLICAZIONE ALLA VALUTAZIONE
      BIOLOGICA DEI DISPOSITIVI MEDICI
    5 CATEGORIZZAZIONE DEI DISPOSITIVI MEDICI
    6 PROCESSO DI VALUTAZIONE BIOLOGICA
    7 INTERPRETAZIONE DEI DATI DELLA VALUTAZIONE BIOLOGICA
    E DELLA VALUTAZIONE COMPLESSIVA SULLA SICUREZZA
      BIOLOGICA
    APPENDICE A (informativa) - PROVE SULLA VALUTAZIONE BIOLOGICA
    APPENDICE B (informativa) - GUIDA AL PROCESSO DI GESTIONE DEL
      RISCHIO
    APPENDICE C (informativa) - PROCEDIMENTO CONSIGLIATO PER
      L'ANALISI DELLA LETTERATURA
    APPENDICE ZA (informativa) - RAPPORTO FRA LA PRESENTE NORMA
      EUROPEA E I REQUISITI ESSENZIALI DELLA DIRETTIVA UE
      93/42/CEE CONCERNENTE I DISPOSITIVI MEDICI
    APPENDICE ZB (informativa) - RAPPORTO FRA LA PRESENTE NORMA
      EUROPEA E I REQUISITI ESSENZIALI DELLA DIRETTIVA UE
      90/385/CEE CONCERNENTE I DISPOSITIVI MEDICI IMPIANTABILI
      ATTIVI
    BIBLIOGRAFIA

    Abstract - (Show below) - (Hide below)

    Specifies: - the general principles governing the biological evaluation of medical devices within a risk management process; - the general categorization of devices based on the nature and duration of their contact with the body; - the evaluation of existing relevant data from all sources; - the identification of gaps in the available data set on the basis of a risk analysis; - the identification of additional data sets necessary to analyse the biological safety of the medical device; - the assessment of the biological safety of the medical device.

    General Product Information - (Show below) - (Hide below)

    Development Note Supersedes UNI EN 30993-1 (07/1999)
    Document Type Standard
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    Status Superseded
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    UNI 11533 : 2014 MASS-PRODUCED ORTHOPEDIC FOOTWEAR DESIGNED FOR FOOT ORTHOTIC - SAFETY AND PERFORMANCE REQUIREMENTS AND TEST METHODS

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    ISO 10993-3:2014 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
    ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
    ISO 10993-16:2017 Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
    ISO/TS 10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
    ISO 10993-13:2010 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
    ISO 7405:2008 Dentistry Evaluation of biocompatibility of medical devices used in dentistry
    ISO 10993-14:2001 Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
    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 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
    ISO 9004:2009 Managing for the sustained success of an organization A quality management approach
    ISO 10993-11:2017 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
    ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
    ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
    ISO 9001:2015 Quality management systems — Requirements
    ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
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