Threshold traceability table

Supplement S2.3

Standalone threshold traceability table for sharing separately from the full S2 configuration. All thresholds must reference ISO 14971:2019 hazard analysis.

Device information

Common header

Device name *

Include version number

Intended use *

Reference IEC 62304 or IFU documentation

Author name *

Author role *

Date *

Organisation *

Threshold specification

Supplementary S2.3

All thresholds must be derived from ISO 14971:2019 hazard analysis. Enter the hazard ID from your risk management file.

Parameter	Symbol	Value	Clinical justification	ISO 14971 hazard ID	Source

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