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IND-02 · Medical Device Cable AssemblyMedical Device
Medical Device
Cable Assembly.
Cable assemblies for diagnostic, monitoring, and surgical equipment under ISO 13485 lot control. IEC 60601-1 isolation, USP Class VI silicone, autoclavable patient leads, 510(k)-ready documentation. Built for medical OEMs and contract manufacturers.
[IND / MEDICAL]
Quality systemISO 13485
IsolationIEC 60601-1
BiocompatibilityUSP Class VI
Lot traceabilityOperator + reel
Procurement Friction · WHERE_IT_SLIPS
Where most medical device programs slip.
PAIN-0101
Autoclave cycle 80 failure
Patient lead fails IEC 60601-1 isolation at 1.5kVAC after 80 autoclave cycles because PVC jacket plasticizer leached out — but spec called for 200-cycle minimum.
PAIN-0202
Plasticizer biocompatibility
Phthalate-bearing PVC fails ISO 10993-10 cytotoxicity on a re-spin lot because supplier swapped wire vendor without re-qualification.
PAIN-0303
ESU return electrode break
Electrosurgical return cable fails impedance spec at the strain-relief junction — patient burn risk flagged in post-market surveillance.
PAIN-0404
DHF documentation gap
Supplier cannot produce IMDS / FAI / device history records during FDA pre-approval audit because no operator traceability was logged at build time.
Capability Stack · WHY_VEINWIRE
Where we move the dial.
F-0101
USP Class VI silicone
Medical-grade platinum-cured silicone overmolds passing ISO 10993-5 (cytotoxicity) and 10993-10 (sensitization).
F-0202
ISO 13485 lot control
Wire reel, connector lot, operator badge, build station logged to ERP per assembly. Records retained 15 years.
F-0303
Autoclave qualification
Patient leads validated to 200+ cycles at 134°C steam per ISO 17665 before release.
F-0404
IEC 60601-1 hipot
100% isolation test at 1500VAC or 4000VAC depending on patient connection class (B / BF / CF).
F-0505
Connector library
LEMO REDEL push-pull, ODU MEDI-SNAP, DIN 42802 ECG, IEC 80601-2 SpO2, Hypertronics monitoring.
F-0606
DHF-ready documentation
FAI, IMDS, control plan, FMEA, biocompatibility chain-of-custody filed per 21 CFR 820.30 Design History File template.
Spec Table · TECH_PARAMS
Build envelope.
| Quality system | ISO 13485:2016 certified. 21 CFR Part 820 compatible workflow. |
|---|---|
| Biocompatibility | USP Class VI materials. ISO 10993-5 / -10 / -11 test reports on file per material. |
| Isolation | 1500VAC (Type B/BF), 4000VAC (Type CF defibrillation-proof) per IEC 60601-1. |
| Sterilization | Autoclave 134°C steam, ETO, gamma 25-50 kGy, e-beam — validated per material. |
| Connector families | LEMO REDEL, ODU MEDI-SNAP, Fischer Core Series, Hypertronics, DIN 42802, IEC 80601-2 standard. |
| Wire spec | UL 1577 reinforced insulation, FEP, PTFE, USP Class VI silicone-jacketed multi-conductor. |
| Overmold | Platinum-cured silicone Shore A 40-70. Color-matched per OEM Pantone reference. |
| Workmanship | IPC/WHMA-A-620 Class 3 default. ISO 13485 lot release with QA signature. |
| Lot traceability | Wire reel, connector lot, operator badge, station ID, timestamp per unit. |
| Lead time | Prototype 96-144h. Production 15-25 business days with DHF docs. |
Fab Protocol · BUILD_PIPELINE
From PO to ship.
PR-0101
Risk class review
Patient connection class (B / BF / CF), sterilization mode, biocompatibility scope reviewed before quote.
PR-0202
Material qualification
Wire and overmold vendors locked at NPI. No second-source substitution without ISO 10993 re-qualification.
PR-0303
Cleanroom build
Class 100,000 (ISO 8) assembly cell with ESD-safe operator stations and gowned access.
PR-0404
Class-3 assembly
Torque-controlled crimping. Operator badge logged per crimp, splice, overmold cycle.
PR-0505
100% hipot test
Every unit tested at 1500VAC or 4000VAC per IEC 60601-1 patient connection class. Records retained 15 years.
PR-0606
DHF package release
FAI dimensional, IMDS, biocompatibility chain, capability study filed per 21 CFR 820.30 before lot ships.
Use Cases · APPLICATIONS
Where this ships.
ECG patient lead sets
10-lead diagnostic ECG with DIN 42802 yoke, color-coded leads, defibrillation-proof IEC 60601-2-25 isolation.
SpO2 sensor cables
Reusable pulse-ox cable per IEC 80601-2-61 with USP Class VI silicone overmold and 200-cycle autoclave qual.
Electrosurgical return electrodes
ESU return cable with REM impedance monitoring contact and split-pad connection per IEC 60601-2-2.
Endoscope video tethers
Hybrid power-video cable, autoclavable to 134°C, LEMO REDEL push-pull connector with ETO seal.
Infusion pump harnesses
Internal device harness for syringe and peristaltic pumps, ISO 13485 lot-traceable, IEC 60601-2-24 compliant.
Ultrasound transducer cables
Multi-coax 128-element transducer cable, low-noise shielding, ergonomic strain-relief overmold.
The medical harness failure mode that hurts customers most is plasticizer leaching out of PVC jacket during repeated autoclave — the cable passes IEC 60601-1 hipot on day one and fails at cycle 80. Customer's 510(k) test plan called for 200 cycles. We refuse to quote PVC for any patient-contact assembly going through steam sterilization. Platinum-cured silicone or FEP, full stop. The cost delta is 15-20% at the cable; the cost of a recall is the company.
FAQ · SPEC_QUERIES
Procurement questions.
Are you ISO 13485 certified?+
Yes — ISO 13485:2016 certified with current valid registration. Audit-ready documentation, internal audit log, CAPA system, and management review records maintained per the standard. Certificate available under NDA.
Can you support a 510(k) submission?+
Yes. We provide the supplier-side Design History File (DHF) inputs: FAI dimensional reports, biocompatibility chain-of-custody (ISO 10993-5/-10/-11), control plan, FMEA, and capability study. Customer integrates into their submission package.
What is the isolation test voltage for patient-contact cables?+
1500VAC for Type B and BF applied parts. 4000VAC for Type CF defibrillation-proof applied parts. Test held for 1 second minimum, 60 seconds for first-article verification per IEC 60601-1 clause 8.8.3.
Do you build cleanroom-only or general assembly?+
Medical assemblies are built in our Class 100,000 (ISO 8) cell with ESD-safe stations and gowned operator access. General industrial assembly runs in a separate production area to prevent cross-contamination.
How long are medical lot records retained?+
15 years minimum per ISO 13485 clause 4.2.5 — operator badge, wire reel, connector lot, station ID, hipot result, visual inspection logged to ERP for every unit. Customer audit access available under NDA.
Sibling specs
Industries served
Capability deep-dives
Engage · RFQ_INTAKE
Quote your medical device program.
Drop drawings, BOM, or rough concept. Engineering reviews within 4 business hours. NDA available on request.
Back to Industries hubEngage · CTA_002
Quote your medical cable program.
Send patient connection class, sterilization mode, connector targets. ISO 13485 lot quote within 4 business hours. Response within 4 business hours. No obligation. Drawings stay under NDA.