MED-005

Pack: F_OVERLAY Severity: major

Cleanability/bioburden-related design constraints treated as DFM risks when relevant

Rule Card

Field	Value
Pack	F_OVERLAY — Industry Overlay and Compliance
Title	Cleanability/bioburden-related design constraints treated as DFM risks when relevant
Severity	major
Check logic	LLM-assisted
Applies to	Compliance overlay
Inputs required	surface_finish_spec, material_spec
Fix template	Add required compliance evidence and overlay-specific controls.

Short Description

Cleanability/bioburden-related design constraints treated as DFM risks when relevant. F6 Test & measurement / lab equipment

When It Applies

This rule runs only when an overlay activates F_OVERLAY. It targets Compliance overlay.

Evidence Profile

Input	Category
surface_finish_spec	Drawing / Spec
material_spec	Drawing / Spec

References

Reference	Type	Title
REF-MED-RISK	standard	ISO 14971: Medical device risk management
REF-HYG-1	guide	EHEDG Guideline 8 (Doc 8) — Hygienic design principles (guidance)

Sources

• D:\02_Code\36_RapidDraft_DFMBenchmark_ExpertMode\server\dfm\manifest.json
• D:\02_Code\36_RapidDraft_DFMBenchmark_ExpertMode\server\dfm\rule_library.json
• D:\02_Code\36_RapidDraft_DFMBenchmark_ExpertMode\server\dfm\references.json
• D:\02_Code\36_RapidDraft_DFMBenchmark_ExpertMode\server\dfm\process_classifier.json
• D:\02_Code\36_RapidDraft_DFMBenchmark_ExpertMode\server\dfm\overlays.json
• D:\02_Code\36_RapidDraft_DFMBenchmark_ExpertMode\server\dfm\roles.json
• D:\02_Code\36_RapidDraft_DFMBenchmark_ExpertMode\server\dfm\report_templates.json
• D:\02_Code\36_RapidDraft_DFMBenchmark_ExpertMode\server\dfm\ui_bindings.json