Medical Wire Harness Solutions

Custom Medical Wire Harness & Cable Assembly

Our medical wire harness assemblies serve Class I/II medical peripherals and rehabilitation devices with patient safety as the core priority. Manufactured in an ISO 13485 certified facility with biocompatible silicone & TPU materials complying with IEC 60601. Custom Class 10,000 clean room production areas are available for strict medical projects, with full electrical & mechanical testing on all finished wiring

Custom Medical Wire Harness Manufacturing

Request a Medical Project Quote

Send your requirements, our medical engineering team will respond within 24 hours.

Core Medical Applications

Medical Wire Harness Catalog

Custom cable assemblies built for Class I & II medical peripherals and home rehabilitation equipment, meeting strict biocompatibility, disinfection resistance and stable signal standards for clinical wards and home-care scenarios.

MRI Coil Wire Harness

Patient Monitoring Peripherals

Light hypoallergenic flexible monitoring leads, alcohol-resistant.

  • Biocompatibility: ISO 10993-1
  • Shielding: Non-Magnetic
  • Flex Life: 5M Cycles
Patient Monitor Cable Assembly

Rehabilitation & Home Healthcare Equipment

Flex-proof wiring for rehab & wearable home medical equipment

  • Safety:IEC 60601-1
  • Jacket:Medical silicone
  • Connector:Snap-Lock medical connector
Surgical Robot Cable

Class II Diagnostic Auxiliary Hardware

EMI-isolated harnesses for diagnostic accessories with steady signal.

  • Disinfection Compatibility:EtO, alcohol wipe disinfection
  • Shielding:Double-layer EMI isolation routing
  • Sealing:IP67 dust & moisture resistance
Medical Engineering Capabilities

Medical Device Cable Assemblies Engineered for Patient Safety, Reliability & Clinical Applications

Our custom wiring serves Class I & II monitoring peripherals and rehabilitation healthcare devices, adopting biocompatible materials compliant with IEC 60601 safety standards. Raw materials are validated to withstand mainstream disinfection & sterilization processes via third-party outsourcing. Stable signal performance and long service life are guaranteed for ward and home rehabilitation scenarios.

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Biocompatibility & Safety

ISO 10993-1 certified hypoallergenic TPU & silicone for patient-contact rehab leads, preventing skin irritation.

Compliance: ISO 10993-1
Safety: IEC 60601-1
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Sterilization Resilience

Materials validated for third-party EtO, Gamma & 134°C autoclave sterilization without performance degradation.

Autoclave: 134°C / 2 bar
Methods: EtO, Gamma
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High-Fidelity Signal Integrity

Precision impedance-controlled twisted/micro-coaxial cables for noise-free monitoring & rehab device signals.

Impedance: Controlled 50/75Ω
Shielding: Non-Magnetic Braid
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Micro & High-Density Assembly

1.25mm micro-connector compact routing for portable wearable rehab gear, IPC Class 3 compliant.

Pitch: Down to 1.25mm
Standard: IPC Class 3
Technical Specifications

Medical Wire Harness Design Parameters

Our engineering team develops wiring assemblies by complying with complete medical standards for clinical wards and home-care scenarios.

Safety & Environmental Performance

Parameter Specification
Biocompatibility ISO 10993-1 (Cytotoxicity, Sensitization, Irritation)
Safety Standard IEC 60601-1 (Medical Electrical Equipment)
Sterilization Materials compatible with third-party EtO, Gamma & 134°C autoclave sterilization
Chemical Resistance Resistant to clinical cleaning agents & disinfectants
Cleanroom Assembly Customizable Class 10,000 (ISO 7) cleanroom available on project demand

Electrical & Mechanical Performance

Parameter Specification
Impedance Control 50Ω, 75Ω, 100Ω (±5%)
Connector Pitch Down to 1.25mm (micro-connectors)
Flex Life >10 million cycles (for monitoring & rehabilitation probes)
Connector Mating ≥500 cycles (medical grade)
Compliance ISO 13485, IPC/WHMA-A-620 Class 3
Production Workflow & Assurance

Medical Wire Harness Manufacturing Process

We adopt standardized production workflows including full electrical & microscopic inspection. Custom Class 10,000 (ISO 7) cleanroom zones can be built on-site as required with complying with ISO 13485 & IEC 60601-1 standards.

01
Design & Risk Analysis (FMEA)

Medical DFM & FMEA risk analysis complying with IEC 60601-1.

02
Cleanroom Material Prep

Class 10,000 cleanroom zone buildable per project demand.

03
Micro-Precision Crimping

Automatic crimping for 1.25mm micro connectors, IPC Class 3 compliant.

04
Assembly & Overmolding

Medical silicone/TPU overmolding for IP67/IP68 dust & disinfectant sealing.

05
100% Electrical & Visual Inspection

Full continuity, hipot, insulation resistance and microscopic inspection.

Laboratory & Quality Assurance

In-house testing lab ensures consistent reliability; custom cleanroom zones for high-grade medical orders.

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Electrical Testing Lab

100% Hi-pot, continuity & insulation resistance testing.

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Flex & Fatigue Validation

In-house flex test over 10 million cycles. Class 10,000 Cleanroom

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Class 10,000 Cleanroom

Reserved space for custom ISO7 Class 10,000 cleanroom.

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Full DHR Traceability

Full batch DHR records for global medical audits & IEC 60601 certification.

Certifications & Compliance

Medical Quality Assurance Infrastructure

We operate under ISO 13485 medical device quality management system, delivering full batch DHR traceability documentation to meet global regulatory standards. Custom Class 10,000 cleanroom zones and third-party sterilization support are available on demand.

ISO 13485 Certificate
ISO 13485:2016

Medical Device QMS

IEC 60601 Compliance
IEC 60601-1

Medical Electrical Safety

ISO 10993 Biocompatibility
ISO 10993-1

Biocompatibility Test Reports

FDA Registration
FDA Registered

Facility & Device Listing

Frequently Asked Questions

Common Questions About Medical Wire Harnesses

Yes. We specialize in custom medical wire harness and cable assembly manufacturing for diagnostic equipment, patient monitoring systems, imaging devices, laboratory instruments and other medical electronics. Every solution is engineered to meet your electrical, mechanical and application requirements.

Yes. We manufacture from CAD drawings, 2D/3D models, BOMs and physical samples. Our engineering team reviews every project to optimize manufacturability, reliability and production efficiency before manufacturing begins.

Yes. We offer rapid prototype manufacturing to verify fit, function and performance before mass production. Prototype validation helps shorten development cycles and reduce project risks.

Every medical wire harness undergoes comprehensive in-house testing, including continuity, insulation resistance, Hi-Pot testing, terminal pull-force and connector retention testing. Additional environmental and application-specific testing is available upon request.

Yes. We source components according to your Approved Vendor List (AVL), including leading European and US brands. Components are purchased through authorized distributors such as DigiKey and Mouser to ensure full traceability and genuine parts.

Yes. We offer halogen-free, low-smoke and recyclable materials that comply with RoHS, REACH and other environmental regulations. Material selection can also support your sustainability and life cycle assessment (LCA) requirements.

Yes. We provide complete OEM and ODM manufacturing services, including engineering support, design optimization, prototyping, production and quality control for medical device manufacturers worldwide.

Quality is controlled throughout the entire manufacturing process, from incoming material inspection and process monitoring to 100% electrical testing before shipment, ensuring reliable performance and consistent product quality.
Committed to Patient Safety

Your Trusted Medical Wire Harness Manufacturer

Kaweei delivers reliable, high-performance wire harness solutions for medical applications, manufactured to the highest quality standards in cleanroom environments.

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ISO 13485 Certified

Medical-specific quality management system

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ISO 10993-1 Materials

Biocompatible & hypoallergenic

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Class 10,000 Cleanroom

ISO 7 certified assembly environment

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Full DHR Traceability

Full DHR Traceability

Start Your Medical Project

Submit your requirements. Our medical engineering team will provide FMEA review and timeline within 24 hours.

sale@kaweei.com
+86-769-8399-1366
Request a Medical Quote

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