Work Item
ASTM WK72659
New Guide for Guideline for Material Process Validation for Additive Manufacturing of Medical Devices
1. Scope
The promotion of knowledge, stimulation of research and implementation of technology through the development of standards for additive manufacturing technologies. The work of this Committee will be coordinated with other ASTM technical committees and other national and international organizations having mutual or related interests.
Keywords
medical device, validation, qualification, IQ, OQ, PQ, verification
Rationale
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.
Work Item Status
Date Initiated: 04-16-2020
Technical Contact: Joseph Ruppert
Item: 000
Ballot:
Status: