ASTM F3127-22
Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices

Standard No.

ASTM F3127-22

Release Date

2022

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F3127-22

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.

ASTM F3127-22 Referenced Document

• ASTM D543 Standard Practices for Evaluating the Resistance of Plastics to Chemical Reagents
• ASTM E1766 Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices
• ASTM E2857 Standard Guide for Validating Analytical Methods
• ASTM E3106 Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation*， 2022-11-01 Update
• ASTM E3219 Standard Guide for Derivation of Health-Based Exposure Limits (HBELs)
• ASTM E3263 Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues
• ASTM F2459 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
• ASTM F2847 Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments*， 2024-04-22 Update
• ASTM F619 Standard Practice for Extraction of Medical Plastics
• ASTM G121 Standard Practice for Preparation of Contaminated Test Coupons for the Evaluation of Cleaning Agents
• ASTM G122 Standard Test Method for Evaluating the Effectiveness of Cleaning Agents
• ASTM G131 Standard Practice for Cleaning of Materials and Components by Ultrasonic Techniques*， 2023-07-13 Update
• ISO 10993-5 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
• ISO 14971 Medical devices - Application of risk management to medical devices
• ISO 19227 Implants for surgery - Cleanliness of orthopedic implants - General requirements
• ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories [Standard in French]

ASTM F3127-22 history

• 2022 ASTM F3127-22 Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
• 2016 ASTM F3127-16 Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices