Editorial scope guide. The points are also available as readable text below.
A carbon fiber outer housing and a surface that touches the wearer should be specified separately. The shell material name does not describe the complete contact surface, edge finish or comfort of an assembled wearable.
Draw the full contact stack
Show the housing, coating, liner, strap and any adhesive as individual items. Identify which surfaces can touch the user during normal use and adjustment. If a liner separates the shell from skin, include its position and retention method in the assembly definition.
Review edges and contact conditions
Use a representative assembly to check protrusions, pinch points and access for cleaning. A lightweight shell is not proof of comfort or long-term suitability. For a wearable intended as a medical device, the device team must determine the appropriate evaluation; this article does not establish biocompatibility or clinical suitability.
Example scenario
A shell is separated from the wearer by a removable liner, but an exposed fastener becomes accessible when the liner shifts. Include the fastener and liner-retention arrangement in the contact review rather than assessing the shell surface alone.
Points to record
| Contact surfaces | Mark direct and indirect contact through the assembled layers. |
|---|---|
| Edge detail | Specify edge treatment and locations of exposed fasteners. |
| Assembly review | Include liner retention, adjustment and cleaning access. |
Related reading
- Split Lines and Molded Edges: Reviewing a Custom Carbon Fiber Shell
- Approving a Carbon Fiber Surface Sample for Repeat Orders
Background reference: FDA — Basics of Biocompatibility.
Discuss the component requirements
Send the part drawing and the requirements relevant to this guide for a scope review.
Contact Litian Yunde