1. Scope

1.1 This document details cardiac and cardiovascular microphysiological systems (MPS) and their capabilities and in what ways they are an improvement to traditional systems. The purpose of this document is to define the minimum requirements and recommendations for best practices of cardiac MPS performance, components, and documentation. These minimum requirements include the cardiac MPS device characterization, and the cardiac tissues electrophysiologic, inotropic, and chronotropic performance. However, all of these requirements may not be necessary in specific assays. 1.2 For the purposes of this guide, MPS are defined as fit-for-purpose devices, with or without flow, containing one or more living or living engineered organ(s), organ substructures, and/or functional unit(s) in a controllable microenvironment. MPS recapitulate one or more aspects of the organ or organ systems dynamics, functionality and/or (patho)physiological response in vivo, and may consist of microchannels lined by living cells. MPS have the capacity to be monitored over real-time and to be integrated with MEMs devices. MPS platforms may comprise mono-cultures, co-cultures of multiple cell types, maintenance of explants derived from tissues/organs, and/or inclusion of organoid cell formations. 1.3 This guide will focus will be on defining functional parameters, including units, activity measurements, biomarkers, assay validation, etc, of MPS that effectively mimic various distinct organ/tissues. 1.4 Units - The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard. 1.5 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 and health practices and determine the applicability of regulatory limitations prior to use.

Keywords

6.1 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; REGENERATIVE MEDICINE; PATIENT SPECIFIC TESTING; BODY-ON-A CHIP; MULTI-ORGANS ON A CHIP; DRUG DEVELOPMENT; MICROPHSYIOLOGICAL MODEL; BODY ON A CHIP; DISEASE MODELS; CARDIAC

Rationale

For this field to continue to grow there needs to be consensus on minimum requirements and best practices for cardiac MPS. This will serve to make conversations between different stakeholders easier. Similarly, it will make the science of cardiac MPS more accessible to the larger tissue engineering field. Finally, it will help journals and reviewers aware of the main stakeholders consensus. These things taken together will create safer and more accessible use of cardiac MPS, while simultaneously growing the confidence in the technology and field.

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