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R0028/2026-03-26/C033

Claim: A pacemaker has more test code than operational code.

BLUF: Unverifiable from available sources. While pacemaker software is safety-critical (IEC 62304 Class C) requiring 100% code coverage and extensive verification, no specific source was found documenting the claim that test code exceeds operational code by volume. Pacemakers have approximately 80,000 lines of code, and the testing requirements are extensive, but the specific ratio of test-to-operational code is not documented in accessible literature.

Probability: Roughly even chance (45-55%) | Confidence: Low

Correction needed: No primary source was found confirming or denying this specific ratio. The claim is plausible given the stringent IEC 62304 Class C requirements but remains unverified.


Summary

Entity Description
Claim Definition Claim text, scope, status
Assessment Full analytical product with reasoning chain
ACH Matrix Evidence x hypotheses diagnosticity analysis
Self-Audit ROBIS-adapted 4-domain process audit

Hypotheses

ID Hypothesis Status
H1 Claim is accurate — test code exceeds operational code Inconclusive
H2 The claim is plausible given safety-critical testing requirements but not verifiable Inconclusive
H3 Claim is materially wrong — test code does not exceed operational code Inconclusive

Searches

ID Target Results Selected
S01 Primary search 10 3

Sources

Source Description Reliability Relevance
SRC01 IEC 62304 and pacemaker software verification literature High High