Active PAR

P2864

Guide for a Software Change Control System for Three-Dimensional (3D) Bioprinting of Tissue-Engineered Medical Products (TEMPs)

This document provides guidelines for how to develop and implement a software change control system to manage all changes made during three-dimensional (3D) printing of medical products to create tissues or tissue-like structures (bioprinting) for transplantation into an animal or human, and/or anatomic modeling purposes. The change control system will provide a process to ensure that the changes made to the product are introduced in a controlled manner.

Sponsor Committee
EMB/Stds Com - Standards Committee
Learn More About EMB/Stds Com - Standards Committee
Status
Active PAR
PAR Approval
2020-03-05

Working Group Details

Society
IEEE Engineering in Medicine and Biology Society
Learn More About IEEE Engineering in Medicine and Biology Society
Sponsor Committee
EMB/Stds Com - Standards Committee
Learn More About EMB/Stds Com - Standards Committee
Working Group
3D-B TEMPs - Three-Dimensional (3D) Bioprinting of Tissue-Engineered Medical Products (TEMPs)
Learn More About 3D-B TEMPs - Three-Dimensional (3D) Bioprinting of Tissue-Engineered Medical Products (TEMPs)
IEEE Program Manager
Malia Zaman
Contact Malia Zaman
Working Group Chair
Lexi Garcia

Other Activities From This Working Group

Current projects that have been authorized by the IEEE SA Standards Board to develop a standard.


No Active Projects

Standards approved by the IEEE SA Standards Board that are within the 10-year lifecycle.


No Active Standards

These standards have been replaced with a revised version of the standard, or by a compilation of the original active standard and all its existing amendments, corrigenda, and errata.


No Superseded Standards

These standards have been removed from active status through a ballot where the standard is made inactive as a consensus decision of a balloting group.


No Inactive-Withdrawn Standards

These standards are removed from active status through an administrative process for standards that have not undergone a revision process within 10 years.


No Inactive-Reserved Standards
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