ASTM WK63284

    New Guide for Detection and Quantification of Cleaning Markers (Analytes) for the Validation of Cleaning Methods for Reusable Medical Devices

    (What is a Work Item?)

    Developed by Subcommittee: F04.15 | Committee F04 | Contact Staff Manager


    1. Scope

    To provide a description of test methods that may be used to evaluate reusable medical devices that become contaminated with soil during clinical use. Performance of these devices for reuse requires cleaning and disinfection/sterilization. Adequate cleaning is not only the first step in processing but also is required to reduce the risk of disease transmission for both the patient and medical practitioner. The soil, if inadequately removed, may interfere with disinfection and sterilization processes, as well as the performance of the device. Acceptance criteria should include a visual assessment and assessment of levels of defined marker(s) endpoints of the soil. Endpoints after cleaning should be established based upon several considerations, including: possible interference with disinfection/sterilization, risk to the patient from contaminants during device use, risk to the healthcare worker during handling, and the limit(s) of detection of the test method(s) employed. Methods for detecting and quantifying the defined markers (analytes) during test will be described.


    Cleaning Markers, Analytes, Contamination, Reprocessing, Reprocess, Process,


    This is the fourth in a series of ASTM Guides authored by ASTM F04.

    The title and scope are in draft form and are under development within this ASTM Committee.

    Citing ASTM Standards
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    Work Item Status

    Date Initiated:

    Technical Contact:
    Kaumudi Kulkarni


    F04 (20-08)

    Ballot Item Approved


    F04 (20-04)

    Negative Votes Need Resolution