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.

Details

Developed by Subcommittee: F42.07

Committee: F42

Staff Manager: Pat Picariello

Work Item Status

Date Initiated: 04-16-2020

Technical Contact: Joseph Ruppert

Item: 000

Ballot:

Status: