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OpenMaterica

OpenMaterica is an open material schema, with an OpenUSD binding, and a Python toolkit for biomedical digital twins. It describes substances in and around the human body (tissues and body fluids, the media and phantoms that stand in for them, agents introduced into them, and the materials of devices that enter or touch them): their fluid, mechanical, acoustic, optical, thermal, dielectric, radiological and magnetic properties, with the provenance and uncertainty of every value. It binds them to anatomical geometry, from a one-dimensional layered path to a full USD scene. It aims to be one physical foundation for high-fidelity solvers (like MIME) and real-time simulators (like NVIDIA Isaac for Healthcare).

Records are plain files any language can read; USD is the primary binding but never required. Model parameter sets name a versioned model family and carry check points, so a solver that reads them in the wrong convention fails loudly instead of silently.

Scope

OpenMaterica describes substances, never systems: not an apparatus or its calibration, not the quantities of one object (its moment, inertia or mean density), not a drive, a procedure or a simulator's tuning. A value belongs here if it is a substance's, measured on a test specimen whose shape and size are recorded; a value of a made object as built (a device, an assembled robot) belongs to its consumer. Geometry is scene data: OpenMaterica defines how geometry binds to materials and ships small test phantoms, never anatomy. Other publishers can use the same machinery in their own namespaces, for data OpenMaterica does not curate. The full statement is in docs/regulatory/intended_use.md.

Status

Design stage. There is no code or release yet. The architecture concept is in design/ARCHITECTURE_DRAFT.md.

Intended use and disclaimers

OpenMaterica is research software. It is not a medical device as defined by EU MDR (EU 2017/745) or US FDA regulations. It has no medical purpose and has not been CE-marked, cleared or approved by any regulatory body. When used as a component within regulated medical software, OpenMaterica is SOUP (Software of Unknown Provenance) under IEC 62304, and the device manufacturer is responsible for assessing its suitability.

Material values in the OpenMaterica library are taken from cited sources, or are fits to cited data. They are not measurements of any particular patient, sample or device; each record states the specimen it was measured on, and whether that specimen stands in for yours is your declaration, not the library's. Biocompatibility fields are never a safety claim. See docs/regulatory/intended_use.md.

Documentation

Document Description
design/ARCHITECTURE_DRAFT.md Architecture concept: components, data model, model families, geometry and USD binding, library and licensing, MIME and Isaac for Healthcare interfaces
DOCUMENTATION_ARCHITECTURE.md How OpenMaterica is documented and verified, and its SOUP readiness
CONTRIBUTING.md Project constraints (including commit sign-off), code rules, identifiers, family and data rules, data attestation, takedown, anomaly lifecycle
SECURITY.md Vulnerability reporting
CHANGELOG.md Version history
docs/regulatory/ Intended use and regulatory boundary
docs/validation/ Known anomalies registry

License

Code: Apache License 2.0. See LICENSE. The curated material library will be released separately, as static archived releases with a DOI, under CC0-1.0.

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