ASTM F3570-22

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
1
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
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.
1
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.
2
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.
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