IEC

IEC 62304

Medical device software — software life-cycle processes. The international software-safety standard for medical devices, classifying software into safety classes A, B, and C.

Canonical id: IEC-62304
Declaring specs: 5

Specifications declaring IEC 62304

Foundation

DVEC-001 v1.3
Deterministic Verifiable Execution Contract
The global contract governing the physics of the Axioma framework — defines deterministic execution, the Oracle Boundary, and the evidence chain.

L2

CI-MATH-001 v1.0
Certifiable Inference Mathematical Specification
The mathematical foundation for deterministic neural network inference — Q16.16 arithmetic and layer operations, every code path bound to a named theorem.
SRS-006-CONVOLUTION v0.1
Deterministic 2D Convolution
2D convolution for safety-critical computer vision — sliding-window dot products with bit-perfect parity and bounded execution time across all platforms.
SRS-008-POOLING v0.1
Max Pooling Layer
Deterministic max pooling for CNNs — bit-perfect spatial reduction with zero dynamic allocation; companion to SRS-006 at the L2 inference boundary.

L7

SRS-007 v0.3
Proof-Carrying Governance & Compliance
The L7 governance contract — governance as cryptographic proof, a deterministic program over committed evidence that turns assertion into citation.