Work Item
ASTM WK72659

New Guide for Guideline for Material Process Validation for Additive Manufacturing of Medical Devices

1. Scope

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

Committee: F42

Staff Manager: Pat Picariello

Work Item Status

Date Initiated: 04-16-2020

Technical Contact: Joseph Ruppert

Item: 006

Ballot: F42 (22-09)

Status: Negative Votes Need Resolution