01Conductive geometry
Release controlRelease active area, printed pattern, edge margin, current-entry region, trace transition, orientation, and tolerance.
If it is missingA pad with the correct outside shape has a different conductive area than the OEM evaluated.
02Lead or connector interface
Release controlDefine wire, snap, tab, printed tail, connector, attachment, reinforcement, polarity marking, mating part, and pull method.
If it is missingThe interface adds stiffness, shifts the conductor, or does not match the OEM cable.
03Backing and edge construction
Release controlControl backing, foam or nonwoven, reinforcement, edge seal or margin, adhesive-free zones, and handling tabs.
If it is missingThe converted edge or lead transition differs from the released mechanical construction.
04Adhesive or hydrogel zones
Release controlMap exact project-specified material, active coverage, overlap, thickness, liner, and non-contact areas.
If it is missingThe active area is covered, exposed, or changed by uncontrolled material overlap.
05Electrical inspection boundary
Release controlDefine continuity, resistance method, isolation, attachment, conditioning, fixture, sampling, and records.
If it is missingA manufacturing result is interpreted as proof of current distribution, temperature, or patient safety.
06Package and change control
Release controlRelease liner, label, count, pouch or tray, storage and shipment conditions, lot traceability, substitutions, and notification.
If it is missingMaterial or package changes enter production without OEM evaluation.