XinHarness manufactures medical-grade cable assemblies and wire harnesses in an ISO 13485-certified, Class 100,000 cleanroom environment. From diagnostic equipment to implantable-adjacent devices, we deliver validated, traceable assemblies for regulated medical OEMs.
Key technical challenges in Medical wire harness manufacturing — and how XinHarness addresses them.
Medical device cables must meet FDA 21 CFR Part 820 and ISO 13485 design-control requirements. We maintain full device history records and traceability from raw material lot to finished assembly.
Patient-contact assemblies require biocompatible materials per ISO 10993. We source and validate insulation and connector materials for skin and short-term tissue contact applications.
Sensitive electronic assemblies are built in our Class 100,000 cleanroom to prevent particulate contamination that could compromise sterility or signal integrity.
Assemblies are validated for compatibility with EtO, gamma, and autoclave sterilization cycles without degradation of insulation or connector seals.
ECG leads, SpO2 sensor cables, vital-signs monitor harness
MRI/CT coil cables, ultrasound probe harness, imaging interconnects
Robotic arm harness, precision actuator cables, sterile-field connectors
Lab analyzer wiring, point-of-care device cables, sensor harness
Infusion pump harness, therapy device cables, power/data assemblies
Miniaturized flex cables, wearable sensor harness, biosensor leads
| Voltage Rating | 5V – 48V DC |
| Wire Gauge | 0.08 – 10 mm² (AWG 8–36) |
| Sterilization | EtO, Gamma, Autoclave compatible |
| Biocompatibility | ISO 10993-5 / -10 tested materials |
| Cleanroom Class | ISO 8 (Class 100,000) |
| Testing | 100% electrical + continuity + hi-pot + visual |
Describe your requirements and receive a detailed technical response within 24 hours.
Our dedicated Medical Division operates independently from general industrial production, with segregated cleanroom manufacturing, lot-controlled materials, and full design-history-file documentation. We support Class II and Class III device OEMs from prototype through validated production.
About XinHarnessWe manufacture under ISO 13485:2016 quality management with full design-history-file support for FDA 21 CFR Part 820 submissions. We are a component supplier, not a device registrant.
Yes. We supply material certificates and ISO 10993 test data for all patient-contact materials used in your assembly.
Our medical division operates an ISO 8 (Class 100,000) cleanroom with gowning protocols, particle monitoring, and ESD control.
Yes. We select materials compatible with autoclave, EtO, and gamma sterilization methods based on your device requirements and provide supporting material data.
Yes. Our engineering team supports design-for-manufacturability review and design transfer from prototype through validated production, with documentation aligned to your quality system.
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Submit your drawings or specifications. Our engineers will respond with a technical review and competitive quote within 24 hours.
