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  • ASTM
    F3127-22 Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices (Redline)
    Edition: 2022
    $103.58
    Unlimited Users per year

Description of ASTM-F3127 2022

ASTM F3127-22

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




ASTM F3127

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—The following items / medical devices / processes are excluded from the scope of this document:

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 be a replacement for biological safety testing.

1.5 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.


Keywords


ICS Code

ICS Number Code 11.080.01 (Sterilization and disinfection in general)


DOI: 10.1520/F3127-22

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About ASTM

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide.
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