This guide provides an overview of specifications, requirements, and example means of compliance for process qualification of materials used to produce medical devices produced with the additive manufacturing processes.
medical device, validation, qualification, IQ, OQ, PQ, verification
Guidance for the medical device industry for how to validate novel additive manufacturing processes to be used to manufacture medical devices. Key users would be OEMs, contract manufacturers and regulatory bodies.
The title and scope are in draft form and are under development within this ASTM Committee.
Developed by Subcommittee: F42.07
Staff Manager: Pat Picariello
Date Initiated: 04-16-2020
Technical Contact: Joseph Ruppert
Ballot: F42 (22-09)
Status: Negative Votes Need Resolution