Small-diameter wire rope or cable assemblies may be reviewed as mechanical components for medical equipment when the purchaser provides a controlled drawing and complete technical requirements.
Material and surface requirements, including required documentation.
Cable construction, diameter, tolerance and finished length.
End fittings, mating components and assembly cleanliness requirements.
Load, movement, bend, cycle life and test method.
Quantity, traceability, packaging and destination.
ASTRO does not infer medical-device approval, biocompatibility, sterility or clinical suitability from a cable specification. The device manufacturer must define regulatory classification, validation and acceptance requirements.
Send the controlled component drawing, material and inspection requirements, mechanical duty, test plan and quantity.
