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Level | MID | UID | PREFIX | REFS |
Title |
Statement |
Rationale |
Comment |
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TEXT
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All BioFlow product requirements live here, authored in
StrictDoc.
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SECTION
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1
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Layout |
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TEXT
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The requirements graph is split across three specification tiers
(matching the IEC 62304 §5.2 + §5.3 V-model layout) plus three
test-spec documents:
10_system.sdoc — System / stakeholder requirements (prefix
SYS-). Device-level commitments — what the device, as a whole,
must do. Maps to ISO/IEC/IEEE 29148 System Requirements.11_srs.sdoc — Software Requirements Specification (prefix
SRS-). Software-level requirements — what the software must do.
Maps to IEC 62304 §5.2 Software Requirements.20_architecture.sdoc — Software Architecture Description
(prefix ARCH-). Architectural elements — subsystems, interfaces,
SOUP, segregation. Maps to IEC 62304 §5.3 Software Architecture.30_unit_tests.sdoc — Unit test specifications (prefix UT-).31_integration_tests.sdoc — Integration test specifications (prefix
IT-).32_system_tests.sdoc — System test specifications (prefix ST-).strictdoc_config.py — StrictDoc project configuration.
A fourth tier for §5.4 Detailed Design is intentionally absent —
Class B does not require it. (See dev-docs/strictdoc.md and the
strictdoc-requirements skill for the full rationale.)
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SECTION
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2
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Authoring |
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TEXT
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Each .sdoc document's [GRAMMAR] block enforces field shapes, the
TYPE vocabulary, and the typed-link roles at parse time. For all
authoring rules — tier selection, TYPE classification, verification
minimums, completeness checklist — see
.claude/skills/strictdoc-requirements/SKILL.md.
Change records for edits to baselined items live in changes/ (see
changes/README.md).
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SECTION
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3
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Running StrictDoc |
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TEXT
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Developer-facing install, export, web-UI, version-bump, and SOUP details
are in dev-docs/strictdoc.md. Short version:
uv sync # install
uv run strictdoc export regulatory-docs/ --output-dir regulatory-docs/output # export HTML
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