Work Item
ASTM WK75166

New Terminology for Standard Terminology Relating to Microphysiological Systems

1. Scope

1.1 This terminology document defines basic terms and specific use of terms related to Microphysiological Systems (MPS). Committee F04 has defined these terms for the purpose of unifying the language used in standards and publications for MPS. 1.2 The terms and relationships defined here are limited to MPS. They do not apply to any medical products of human origin regulated by the U.S. Food and Drug Administration under 21 CFR Parts 16 and 1270 and 21 CFR Parts 207, 807, and 1271. 1.3 The terms and nomenclature presented in this standard are for the specific purposes of unifying the language used in MPS standards and are not intended for labeling of regulated medical products. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Keywords

Organ on a chip; organs-on-chips; microphysiological systems; tissue-on-a-chip; drug discovery; pathophysiology studies; drug validation, disease models; precision medicine; alternatives to animal models; pharmacology testing; in vitro testing; ex vivo testing; physiology studies; drug studies; biomedical research; drug screen; in vitro/ex vivo drug screening system; in vitro/ex vivo physiology study system; toxicology; 3 Rs; regenerative medicine; patient specific testing; Body-on-a Chip; Multi-organs on a chip; Drug Development; microphsyiological model; ADMET; body on a chip; disease models;

Rationale

For this field to continue to grow there needs to be consensus on basic terminology and the specific use of the terminology. This will serve to make conversations between different stakeholders easier. Similarly, it will make the science of MPS more accessible to the larger tissue and microsystems engineering field. Finally, it will help journals and reviewers aware of the main stakeholders consensus. The main users of this document would be the end-users, such as pharmaceutical companies, researchers, reviewers, and even potentially regulators and policymakers.

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

Details

Developed by Subcommittee: F04.43

Committee: F04

Staff Manager: Kathleen Chalfin

Work Item Status

Date Initiated: 12-11-2020

Technical Contact: Catherine Zander

Item: 003

Ballot: F04 (22-03)

Status: Ballot Item Approved

Item: 001

Ballot: F04.43 (21-01)

Status: Will Reballot Item

Item: 023

Ballot: F04 (22-01)

Status: Withdrawn From Balloting