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    Biocompatibility Matrix

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    Mico Stanojevic
    The document outlines a testing matrix for evaluating the biocompatibility of medical devices based on International Organization for Standardization (ISO) 10993 standards and Food and Drug Administration (FDA) guidance. The matrix provides recommendations for which biological safety tests should be conducted based on the device's intended contact duration and location within the body (e.g. skin, mucous membranes, blood-contacting). While the matrix serves as a guideline, the document stresses that the specific tests required depend on each individual device's unique characteristics.

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    Biocompatibility Matrix

    Uploaded by

    Mico Stanojevic
    58 views1 page
    The document outlines a testing matrix for evaluating the biocompatibility of medical devices based on International Organization for Standardization (ISO) 10993 standards and Food and Drug Administration (FDA) guidance. The matrix provides recommendations for which biological safety tests should be conducted based on the device's intended contact duration and location within the body (e.g. skin, mucous membranes, blood-contacting). While the matrix serves as a guideline, the document stresses that the specific tests required depend on each individual device's unique characteristics.

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    Biocompatibility definition and testing

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    The document outlines a testing matrix for evaluating the biocompatibility of medical devices based on International Organization for Standardization (ISO) 10993 standards and Food and Drug Administration (FDA) guidance. The matrix provides recommendations for which biological safety tests should be conducted based on the device's intended contact duration and location within the body (e.g. skin, mucous membranes, blood-contacting). While the matrix serves as a guideline, the document stresses that the specific tests required depend on each individual device's unique characteristics.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as pdf or txt
    58 views1 page

    Biocompatibility Matrix

    Uploaded by

    Mico Stanojevic
    The document outlines a testing matrix for evaluating the biocompatibility of medical devices based on International Organization for Standardization (ISO) 10993 standards and Food and Drug Administration (FDA) guidance. The matrix provides recommendations for which biological safety tests should be conducted based on the device's intended contact duration and location within the body (e.g. skin, mucous membranes, blood-contacting). While the matrix serves as a guideline, the document stresses that the specific tests required depend on each individual device's unique characteristics.

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    BIOCOMPATIBILITY TEST MATRIX

    Specific safety evaluation programs follow International Organization for Standardization (ISO) 10993 standards and Food and
    Drug Administration (FDA) guidance (May 1, 1995). The table is based on ISO 10993-1 Evaluation and testing, 2009 edition.
    While the table has been developed as a guideline for biocompatibility testing, it is essential that each device be evaluated
    based on its own unique characteristics.

    BODY CONTACT

    Subchronic Toxicity

    Skin

    SURFACE DEVICES

    Mucosal Membrane

    Breached or
    Compromised
    Surfaces

    Blood Path, Indirect

    EXTERNALLY
    COMMUNICATING
    DEVICES

    Tissue/Bone/Dentin
    Communicating1

    Circulating Blood

    Tissue/Bone

    IMPLANT DEVICES

    Blood

    o
    x

    o
    x

    o
    x
    x

    O = Additional tests that may be applicable in the U.S.


    Note1 - Tissue includes tissue fluid and subcutaneous spaces

    X = Tests per ISO 10993-1

    Note2 - For all devices used in extracorporeal circuits

    Carcinogenicity

    Acute Systemic Toxicity

    Hemocompatibility

    Irritation/Intracutaneous

    C = Permanent
    (>30 Days)

    Implantation

    Sensitization

    B = Prolonged
    (24 Hours - 30 Days)

    Genotoxicity

    Cytotoxicity

    A = Limited
    (<_ 24 Hours)

    Chronic Toxicity

    CONTACT DURATION

    Biodegradation

    BIOLOGICAL EFFECT
    Reproductive/Developmental

    DEVICE CATEGORIES

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