ASTM F3570-22

Standard Terminology Relating to Microphysiological Systems

SCOPE
1.1 This terminology defines basic terms and presents the relationships of the scientific fields related to microphysiological systems (MPS). Committee F04 has defined these terms for the specific purpose of unifying the language used in standards for MPS.  
1.2 The terms and nomenclature presented in this standard are for the specific purpose of unifying the language used in MPS standards and are not intended for labeling of regulated medical products.  
1.3 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.  
1.4 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.

General Information

• Status: Published
• Publication Date: 31-May-2022
• ICS: 01.040.07 - Natural and applied sciences (Vocabularies)
• ICS: 01.040.11 - Health care technology (Vocabularies)
• ICS: 07.080 - Biology. Botany. Zoology
• ICS: 11.020.20 - Medical science
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.43 - Cells and Tissue Engineered Constructs for TEMPs

Overview

ASTM F3570-22: Standard Terminology Relating to Microphysiological Systems provides a unified vocabulary for the rapidly evolving field of microphysiological systems (MPS). Developed by ASTM Committee F04, this standard is essential for researchers, regulators, and industry professionals seeking consistent terminology when discussing, designing, or standardizing MPS and their related scientific domains. While these definitions serve to harmonize communication in MPS standards, they are not intended for use in labeling regulated medical products.

Key Topics

ASTM F3570-22 introduces and precisely defines core terms fundamental to the MPS field, covering a range of in vitro model systems, devices, platforms, and supporting scientific concepts. Key covered terminology includes:

• Microphysiological Systems (MPS): Fit-for-purpose devices modeling aspects of organ or system physiology, integrating engineered organ units in controlled microenvironments.
• Organ-on-a-Chip and Tissue-on-a-Chip: Nomenclature for platforms replicating organ or tissue functions, structure, and (patho)physiological responses in vitro.
• Body-on-a-Chip and Human-on-a-Chip: Advanced models integrating multiple organ mimics for systemic responses or patient-specific simulation.
• Disease-on-a-Chip: In vitro systems modeling specific diseases, including genetic and environmental factors, to simulate disease progression and therapeutic responses.
• Organoid: Self-assembled, 3D tissue or organ models derived from stem cells, mimicking in vivo anatomy and function.
• Microfluidics and MEMS (Micro-Electro Mechanical Systems): Technologies used to control environments and facilitate biological function and simulation on the microscale.
• Functional Attributes: Definitions relating to preserved anatomy and functionality, as well as organized and disorganized 2D/3D systems.

By harmonizing terminology for devices, biological models, enabling technologies, and functional descriptors, ASTM F3570-22 facilitates clear communication, protocol development, and collaboration in biomedical research and product development.

Applications

The unified terminology provided by ASTM F3570-22 supports a wide range of practical and emerging applications, including:

• Drug Discovery and Development: Standardized language enhances data exchange and reproducibility in pharmaceutical research by defining organ-on-chip, tissue-on-chip, and disease modeling technologies.
• Toxicology and Pharmacology Studies: Facilitates the creation and interpretation of in vitro and ex vivo testing platforms designed to predict human responses, reducing reliance on animal models.
• Biomedical Research: Promotes consistency in research documentation and cross-study comparisons involving MPS, organoids, and related engineered biological models.
• Precision Medicine and Patient-Specific Testing: Enables accurate communication in the context of human-on-a-chip or subject-on-a-chip systems for personalized drug screening and therapeutic development.
• Regulatory Submissions and International Collaboration: Adoption of internationally recognized terminology aids multinational cooperation, harmonizes reporting, and aligns with World Trade Organization principles on technical barriers to trade.

Related Standards

For comprehensive alignment and integration in the MPS and tissue engineering landscape, ASTM F3570-22 references and complements these related international standards:

• ISO 22442-1:2020: Medical Devices Utilizing Animal Tissues and Their Derivatives
• ISO/TS 21560:2020: General Requirements of Tissue-Engineered Medical Products

Organizations involved in biomedical device development, drug testing, or tissue engineering should refer to these documents for broader regulatory and technical guidance.

Conclusion

ASTM F3570-22 is an essential standard for professionals working with microphysiological systems, offering standardized terminology for improved communication, research, and innovation. Its adoption underpins advancements in drug development, biomedical research, toxicology, and precision medicine, while supporting global harmonization of standards. For anyone engaged in the creation, usage, or regulation of MPS technologies, referencing ASTM F3570-22 ensures clarity, consistency, and alignment with international best practices.

Standards Content (Sample)

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.
Designation: F3570 − 22
Standard Terminology Relating to
Microphysiological Systems
This standard is issued under the fixed designation F3570; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope biosensor, n—devices that use specific biochemical reactions
and/or molecular recognition to detect the presence and/or
1.1 This terminology defines basic terms and presents the
the concentration of an analyte. Biosensors consist of three
relationships of the scientific fields related to microphysiologi-
parts: a component that recognizes the analyte and produces
cal systems (MPS). Committee F04 has defined these terms for
a signal, a signal transducer, and a detector/reader device.
the specific purpose of unifying the language used in standards
for MPS.
body-on-a-chip, n—interconnected organ mimics with con-
tinuous or recirculating flow, with organ sizes and flow
1.2 The terms and nomenclature presented in this standard
determined by a physiologically based pharmacokinetic
are for the specific purpose of unifying the language used in
(PBPK) model. It can consist of human and/or animal cells
MPS standards and are not intended for labeling of regulated
and contains all organs with some listed explicitly and others
medical products.
grouped as “other tissues” integrated within a non-biological
1.3 This standard does not purport to address all of the
platform.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro- disease-on-a-chip, n—an in vitro model system with the
priate safety, health, and environmental practices and deter- desired genetic background disease, environmental factors,
mine the applicability of regulatory limitations prior to use. inducible symptoms, and/or interaction between disease-
1.4 This international standard was developed in accor- relevant cell types under physiological conditions. These
dance with internationally recognized principles on standard- systems incorporate or mimic a specific disease stage in
ization established in the Decision on Principles for the organ(s) or tissues integrated within a non-biological plat-
Development of International Standards, Guides and Recom- form.
mendations issued by the World Trade Organization Technical
disorganized 2D system, n—a cellular monolayer over a
Barriers to Trade (TBT) Committee.
surface which lacks the anatomy of in vivo tissues and need
not possess the physiological functions of in vivo tissues.
2. Referenced Documents
disorganized 3D system, n—a multilayered cellular system
2.1 ISO Standards:
that substantially lacks the ordered histoarchitecture of thein
ISO 22442-1:2020 Medical Devices Utilizing Animal Tis-
vivo organ or tissue and need not possess the physiological
sues and Their Derivatives
function of in vivo tissue.
ISO/TS 21560:2020 General Requirements of Tissue-
Engineered Medical Products
functional microphysiological system,n—a microphysiologi-
cal system that reproduces electrical, mechanical, and/or
3. Terminology
barrier function without necessarily reproducing the
anatomy. Can be 2D, 3D, or hybrid 3D model systems with
biomarker, n—a characteristic that is evaluated as an indicator
functional characteristics of living.
of normal biological processes, pathogenic processes, or
pharmacologic responses to a therapeutic intervention. It is a
human-on-a-chip, n—a subset of body-on-a-chip which con-
portmanteau of “biological marker” and is sometimes re-
sists of various human organ mimics using continuous or
ferred to as a signature molecule.
recirculating flow. Human-on-a-chip can include patient
derived, stem cell derived, or primary cells/tissues integrated
within a non-biological platform.
ThisterminologyisunderthejurisdictionofASTMCommitteeF04onMedical
hybrid 3D systems, n—where a monolayered cellular system
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.43 on Cells and Tissue Engineered Constructs for TEMPs.
is integrated with a MEMs device or devices to provide a
Current edition approved June 1, 2022. Published July 2022. DOI: 10.1520/
multilayered construct that enables the establishment of
F3570-22.
mechanical, electrical, and/or barrier functions that give at
Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036, http://www.ansi.org. least one output similar to that of an in vivo output.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F3570 − 22
micro-electro mechanical systems (MEMs), n—miniature organ-on-a-chip, n—a subset of microphysiological systems
integrated devices or systems that combine mechanical and that replicates one or more aspects of an organ’s in vivo
electrical components ranging in size from a few microm- dynamics, functionality, structure, and/or (patho)physiologi-
eters to a millimeter. They must have elements of defined cal response(s) of multiple cell types integrated within a
mechanical fun
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