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  • UNI EN ISO 10993-15 : 2009

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS

    Available format(s): 

    Superseded date:  03-08-2023

    Language(s): 

    Published date:  17-09-2009

    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 METODI DI PROVA DELLA DEGRADAZIONE
    5 REAGENTE E PREPARAZIONE DEL CAMPIONE
    6 PROVE ELETTROCHIMICHE
    7 PROVA DI IMMERSIONE
    8 ANALISI
    9 RESOCONTO DI PROVA
    APPENDICE A (informativa) - DIAGRAMMA SCHEMATICO DEL CIRCUITO
                DI MISURAZIONE ELETTROCHIMICA
    APPENDICE B (informativa) - RAPPRESENTAZIONE SCHEMATICA DI UNA
                CELLA ELETTROLITICA
    APPENDICE C (informativa) - ESEMPI DI ELETTROLITI ALTERNATIVI
                PER LE PROVE ELETTROCHIMICHE
    APPENDICE ZA (informativa) - RAPPORTO FRA LA PRESENTE NORMA
                 EUROPEA E I REQUISITI ESSENZIALI DELLA DIRETTIVA
                 UE 93/42/CEE
    BIBLIOGRAFIA

    Abstract - (Show below) - (Hide below)

    Offers guidelines on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic medical devices or corresponding material samples finished as ready for clinical use.

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    Committee CT 44
    Development Note Bilingual (Italian + English) version issued in OCTOBER 2011. (10/2011)
    Document Type Standard
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    Status Superseded
    Superseded By
    Supersedes

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

    ISO 10993-16:2017 Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
    NFS 91 141 : 1997 BIODEGRADABILITY OF DENTAL METAL ALLOYS - STANDARDIZATION OF ELECTROCHEMICAL TESTS
    ISO 10993-13:2010 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
    ISO 3585:1998 Borosilicate glass 3.3 Properties
    ISO 10271:2011 Dentistry Corrosion test methods for metallic materials
    ISO 10993-14:2001 Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
    ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
    ISO 8044:2015 Corrosion of metals and alloys Basic terms and definitions
    ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
    ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
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