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  • UNI EN ISO 10993-13 : 2010

    Current The latest, up-to-date edition.

    BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES

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    Published date:  05-08-2010

    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 PROCEDIMENTI DI PROVA
    6 RAPPORTO DI PROVA
    APPENDICE A (informativa) - METODI ANALITICI
    APPENDICE B (informativa) - FESSURAZIONE SOTTO SFORZO PER
                EFFETTO AMBIENTALE (ESC) DEI POLIMERI
    APPENDICE ZA (informativa) - RAPPORTO TRA 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 SUI DISPOSITIVI MEDICI IMPIANTABILI
                ATTIVI
    BIBLIOGRAFIA

    Abstract - (Show below) - (Hide below)

    Describes general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use. Also provides two test methods to generate degradation products, an accelerated degradation test as a screening method and a real-time degradation test in a simulated environment.

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

    Committee CT 44
    Document Type Standard
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    Status Current
    Supersedes

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

    ISO 13781:2017 Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing
    ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
    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
    ISO 14971:2007 Medical devices Application of risk management to medical devices
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