ASTM F3127 - 16

    Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices

    Active Standard ASTM F3127 | Developed by Subcommittee: F04.15

    Book of Standards Volume: 13.02


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    Significance and Use

    5.1 This guide describes an approach to validate a cleaning system for a medical device. It is based on the manufacturer’s accurate and comprehensive understanding of their internal manufacturing and cleaning processes.

    5.2 This guide is not intended to provide a detailed plan or road map, but will provide considerations that can be used by the device manufacturer to develop a detailed plan for performing cleaning validation.

    5.3 In cleaning validation, as with other types of validations, there are multiple ways to achieve a compliant, scientifically sound and practical cleaning validation program.

    5.4 There are several reference documents identified in Appendix X3 that describe cleaning validation approaches for non-medical devices (including cleaning for oxygen-enriched environments, pharmaceuticals, semiconductors). Any of these reference documents could provide guidance for a well defined process for establishing a manufacturer’s minimum expectation of a specific cleaning validation program.

    5.5 This guidance specifically targets cleaning validation for medical devices, in-process and at terminal cleaning so that the result is a consistently clean medical device that meets the performance expectations for that device.

    1. Scope

    1.1 This guide provides considerations for validating cleaning processes for medical devices during initial fabrication and assembly prior to initial use. Validated cleaning processes are important for achieving consistency in function and consistency in biocompatibility. The considerations include but are not limited to, validation approach, equipment design, procedures and documentation, analytical methods, sampling, development of limits, and other issues.

    1.2 Inclusions: 

    1.2.1 This guide describes the validation of critical cleaning processes for medical devices to reduce contaminants to acceptable levels prior to packaging.

    1.3 Exclusions: 

    1.3.1 Reusable medical devices.

    1.3.1.1 Validation of cleaning operations for reusable medical devices is not within the scope of this standard guide. Although cleaning of reusable medical devices is beyond the scope of this guide, many of the principles outlined in this guide may be applicable to the validation of cleaning operations for reusable devices.

    1.3.2 Cleaning of medical devices in health care facilities.

    1.3.2.1 Validation of cleaning processes in patient/health care facilities is not within the scope of this standard guide.

    1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.


    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ASTM Standards

    D543 Practices for Evaluating the Resistance of Plastics to Chemical Reagents

    E2857 Guide for Validating Analytical Methods

    F619 Practice for Extraction of Medical Plastics

    F2459 Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis

    F2847 Practice for Reporting and Assessment of Residues on Single Use Implants

    G121 Practice for Preparation of Contaminated Test Coupons for the Evaluation of Cleaning Agents

    G122 Test Method for Evaluating the Effectiveness of Cleaning Agents

    G131 Practice for Cleaning of Materials and Components by Ultrasonic Techniques


    ICS Code

    ICS Number Code 11.080.01 (Sterilization and disinfection in general)

    UNSPSC Code

    UNSPSC Code


    Referencing This Standard
    Link Here
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    DOI: 10.1520/F3127-16

    Citation Format

    ASTM F3127-16, Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices, ASTM International, West Conshohocken, PA, 2016, www.astm.org

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