ASTM-F3604 2023

$37.38

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

Published By	Publication Date	Number of Pages
ASTM	2023	16

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Categories: 11.040.01 - Medical equipment in general, ASTM

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Description

ASTM F3604-23

Active Standard: Standard Practice for Validating the Additive Manufacturing (AM) Production Process for Medical Devices Produced Using Laser Powder Bed Fusion

ASTM F3604

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.

Keywords

IQ; medical device; OQ; PQ; qualification; validation; verification;

ICS Code

ICS Number Code 11.040.01 (Medical equipment in general)

DOI: 10.1520/F3604-23

Additional information

Standard Title	F3604-23 Standard Practice for Validating the Additive Manufacturing (AM) Production Process for Medical Devices Produced Using Laser Powder Bed Fusion
Published Code	ASTM
Publication Date	2023
Pages Count	16
ICS Codes	11.040.01 - Medical equipment in general