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  • Medical Device Classification

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    HARESH NIRMAL
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    This document provides a table for determining the classification of medical devices based on their intended use, risks, and patterns of use. The table separates devices into body-contacting and non-body-contacting, and assigns a risk class of I, II, or III based on factors like degree of invasiveness, duration of use, impact, and whether the device is active or non-active. For example, liquid transportation devices that contact blood and body fluids are usually class III if for long-term or central circulation use. Implantable devices are generally class III. The notes clarify that class I, II, and III refer to the established risk-based classification categories for medical devices

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    This document provides a table for determining the classification of medical devices based on their intended use, risks, and patterns of use. The table separates devices into body-contacting and non-body-contacting, and assigns a risk class of I, II, or III based on factors like degree of invasiveness, duration of use, impact, and whether the device is active or non-active. For example, liquid transportation devices that contact blood and body fluids are usually class III if for long-term or central circulation use. Implantable devices are generally class III. The notes clarify that class I, II, and III refer to the established risk-based classification categories for medical devices

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    24 views2 pages

    Medical Device Classification

    Uploaded by

    HARESH NIRMAL
    This document provides a table for determining the classification of medical devices based on their intended use, risks, and patterns of use. The table separates devices into body-contacting and non-body-contacting, and assigns a risk class of I, II, or III based on factors like degree of invasiveness, duration of use, impact, and whether the device is active or non-active. For example, liquid transportation devices that contact blood and body fluids are usually class III if for long-term or central circulation use. Implantable devices are generally class III. The notes clarify that class I, II, and III refer to the established risk-based classification categories for medical devices

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    of 2

    Annex

    Table for Determination of Medical Device Classification

    Body-contacting device

    Temporary use Short-term use Long-term use


    Status of Skin Blood Skin Blood Blood
    use Trauma Trauma Skin/Orifice Trauma
    /Orifice circulation /Orifice circulation circulation
    Patterns of use /Tissue /Tissue (openings) /Tissue
    (openings) /Central (openings) / Central / Central

    Liquid transportation
    1 Ⅱ Ⅱ Ⅲ Ⅱ Ⅱ Ⅲ Ⅱ Ⅲ Ⅲ
    device
    Blood and other body
    2 － － Ⅲ － － Ⅲ － － Ⅲ
    fluids alternation device
    3 Medical dressing Ⅰ Ⅱ Ⅱ Ⅰ Ⅱ Ⅱ － Ⅲ Ⅲ
    Non-active
    device 4 Invasive device Ⅰ Ⅱ Ⅲ Ⅱ Ⅱ Ⅲ － － －
    Reusable surgical
    5 Ⅰ Ⅰ Ⅱ － － － － － －
    device
    6 Implantable device － － － － － － Ⅲ Ⅲ Ⅲ
    Contraceptive and
    family planning device
    7 Ⅱ Ⅱ Ⅲ Ⅱ Ⅲ Ⅲ Ⅲ Ⅲ Ⅲ
    (excluding reusable
    surgical device)
    Other non-active
    8 Ⅰ Ⅱ Ⅲ Ⅱ Ⅱ Ⅲ Ⅱ Ⅲ Ⅲ
    devices

    Status of

    use Minor injury Moderate injury Serious injury

    Patterns of use
    Energy treatment
    1 Ⅱ Ⅱ Ⅲ
    device
    Active Diagnostic and
    2 Ⅱ Ⅱ Ⅲ
    device monitoring device
    Liquid transportation
    3 Ⅱ Ⅱ Ⅲ
    device
    Ionizing radiation
    4 Ⅱ Ⅱ Ⅲ
    device
    5 Implantable device Ⅲ Ⅲ Ⅲ
    6 Other active devices Ⅱ Ⅱ Ⅲ

    1
    Non-body-contacting device

    Status of use
    little impact Minor impact Significant impact
    Patterns of use

    Non-active 1 Nursing device Ⅰ Ⅱ －


    device
    Device for medical device
    2 － Ⅱ Ⅲ
    sterilization and cleaning

    3 Other non-active devices Ⅰ Ⅱ Ⅲ

    Status of use
    little impact Minor impact Significant impact
    Patterns of use

    Clinical laboratory
    1 Ⅰ Ⅱ Ⅲ
    instruments
    Active
    device 2 Stand alone software － Ⅱ Ⅲ

    Instruments for medical


    3 devices disinfection and － Ⅱ Ⅲ
    sterilization

    4 Other active devices Ⅰ Ⅱ Ⅲ

    Notes: 1. “I”, “II” and “III” herein respectively refer to class I, II and III medical
    devices.
    2. “-” herein means the situation is inapplicable to any class of medical
    devices.

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