Work Item
ASTM WK77015

New Practice for Machine Learning Training Dataset Structuring and Revision

1. Scope

The scope of the Committee shall be the development of standardized nomenclature and definitions of terms, test methods, recommended practices, guides, specifications and performance standards for medical and surgical materials and devices. The Committee will encourage research in this field and sponsor symposia, workshops and publications to facilitate the development of such standards. The Committee will promote liaison with other ASTM Committees and other organizations with mutual interests.




FDA has released a guidance on the need for AI/ML based systems to be regulated with increasing use of the technologies in medical devices. We would like to proactively create a GxP type document to outline how to bring, use, and update data structures in software as a medical device.

The title and scope are in draft form and are under development within this ASTM Committee.


Developed by Subcommittee: F04.38

Committee: F04

Staff Manager: Kathleen Chalfin

Work Item Status

Date Initiated: 05-21-2021

Technical Contact: Gokce Yildirim

Item: 000