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:
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.