ASTM F3604-23
Standard Practice for Validating the Additive Manufacturing (AM) Production Process for Medical Devices Produced Using Laser Powder Bed Fusion

Scope: 1.1 This practice provides an overview of how to perform process validation for medical devices manufactured using PBF/LB/M. The topics that will be covered include machine qualifications, software used in the manufacturing process, the importance of design specification and verification on process validation, and raw materials.

1.2 This practice also provides recommendations for process characterization, risk management, additive manufacturing (AM) facility qualification, and process control as a prerequisite for qualification activity, including installation qualification/operational qualification/performance qualification (IQ/OQ/PQ).

1.3 The practice is primarily focused on non-device-specific AM system(s) validation. Additional information may be needed in reference to the performance of the actual device.

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

1.5 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 F3604-23 Referenced Document

ASTM F2971 Standard Practice for Reporting Data for Test Specimens Prepared by Additive Manufacturing
ASTM F3049 Standard Guide for Characterizing Properties of Metal Powders Used for Additive Manufacturing Processes
ASTM F3456 Standard Guide for Powder Reuse Schema in Powder Bed Fusion Processes for Medical Applications for Additive Manufacturing Feedstock Materials
ISO 13485
ISO 14971 Medical devices - Application of risk management to medical devices
ISO 9712 Non-destructive testing — Qualification and certification of NDT personnel

2023 ASTM F3604-23 Standard Practice for Validating the Additive Manufacturing (AM) Production Process for Medical Devices Produced Using Laser Powder Bed Fusion