Medical Cable Assembly
Medical-grade cables — compliant by design.
ISO 13485 manufactured cable assemblies using USP Class VI biocompatible materials. For patient-monitoring, imaging, surgical and diagnostic devices.
- 13485 audited
- ISO
- Class VI
- USP
- Hipot tested
- 100%
- Sterilizable
- EtO · γ
Medical Applications
What we build for
Patient-contact, imaging and diagnostic device cables — all built with full DHF documentation.
Biocompatible Materials
Only USP Class VI touches the patient
All patient-contact materials pass ISO 10993 and USP Class VI biocompatibility. We maintain traceability from raw spool to finished device.
Medical Cable Capability
Published medical capability
| Quality system | |
| Certification | ISO 13485:2016 (SGS audited) |
|---|---|
| Risk management | ISO 14971 process |
| Biocompatibility | ISO 10993 · USP Class VI |
| Materials | |
| Jackets | Silicone · PUR · TPE · Medical PVC |
| Overmold | USP Class VI silicone or TPE |
| Shielding | Foil · braid (tinned copper / stainless) |
| Termination | |
| Connectors | LEMO · ODU · Fischer · Amphenol · Redel · custom |
| IP rating | Up to IP68 overmolded |
| Sterilization | |
| Methods | EtO · Gamma · Autoclave (on material spec) |
| Testing | |
| Electrical | 100% continuity · hipot 1,500–3,000 V |
| Mechanical | Pull-off · flex-life · tear strength |
| Documentation | DHF · DHR · traceability per lot |
Frequently Asked Questions
Medical cable FAQ
01Do you provide full DHF / DHR documentation?
Yes. Every medical cable project includes a Design History File (DHF) and per-lot Device History Record (DHR). Used for FDA 510(k) and CE MDR submissions.
02Can we specify our own USP Class VI silicone supplier?
Yes — we work with Nusil, Dow, Shin-Etsu and Saint-Gobain. If you have a supplier-specific grade, ship us the spec and we’ll qualify it into the build.
03What sterilization methods are compatible?
Depends on jacket material. Silicone: autoclave, EtO, gamma. PUR: EtO, gamma. PVC: EtO only. We document method in the assembly drawing.
04Lead time for medical cable prototypes?
First article: 3–5 weeks (includes material qualification and first-article inspection). Production runs: 4–8 weeks depending on volume and sterilization batching.
Ready when you are
Send your Gerber & BOM — get a quote in 24 hours.
NDA available · Free DFM review · Senior engineer response.