In the medical industry, every connection matters. A single wiring fault can compromise patient safety or device performance. That’s why medical wire harness design and certification are not just technical requirements—they are a matter of life and reliability.
With more than 26 years of precision manufacturing experience, TSP provides fully compliant, high-reliability wire harness and cable assembly solutions trusted by global OEMs in healthcare, diagnostics, and medical device manufacturing.
Understanding Medical Wire Harnesses
A medical wire harness organizes and protects multiple wires or cables that transmit power and signals within medical equipment such as imaging systems, ventilators, surgical robots, and patient monitoring devices.
Unlike industrial harnesses, medical versions must withstand:
Sterilization processes (autoclave, EtO, gamma)
Frequent flexing and cleaning
Biocompatibility and safety regulations
Traceability and documentation requirements
Each of these factors makes certification and compliance crucial from design through production.
Key Certifications and Standards for Medical Wire Harnesses
ISO 13485 – Medical Device Quality Management System
Ensures consistent quality and traceability in manufacturing.
A must for any supplier in the medical device supply chain.
UL and CSA Safety Certifications
Verifies material safety, insulation performance, and flammability resistance.
RoHS and REACH Compliance
Guarantees restriction of hazardous substances and chemical safety.
IPC/WHMA-A-620
Defines acceptability standards for wire harness assemblies.
FDA and CE Requirements
For devices entering U.S. or EU markets, ensuring electrical safety and biocompatibility compliance.
ISO 9001 and ISO 14001
Reinforces TSP’s integrated commitment to quality and environmental management.
At TSP, we combine these standards into a single, robust production workflow—backed by meticulous testing and validation.
Why Certification Matters for OEMs
Patient Safety – Certified harnesses minimize electrical faults and contamination risk.
Global Market Access – Compliance enables export to regulated regions such as the EU, U.S., and Japan.
Design Traceability – Each component can be tracked from raw material to finished device.
Reliability Under Stress – Certified materials maintain integrity after sterilization or long-term use.
Partnering with a certified manufacturer ensures your product can pass both regulatory review and long-term operational demands.
How to Design a Certified Medical Wire Harness
Early Collaboration – Involve your harness supplier (TSP) at the design stage to ensure material and process compliance.
Select Medical-Grade Materials – Use biocompatible insulation, high-purity copper, and low-outgassing overmolds.
Plan for Sterilization – Choose materials and seals that survive repeated autoclaving.
Define Documentation Flow – Maintain DHR (Device History Record) and DMR (Device Master Record) for traceability.
Validate and Test – Perform electrical continuity, insulation resistance, flex-life, and environmental stress testing.
TSP’s engineering team offers DFM (Design for Manufacturability) and DFT (Design for Testability) support to shorten validation time and accelerate certification.
TSP’s Advantage in Medical Wire Harness Manufacturing
Comprehensive in-house capabilities: tool & mold design, metal stamping, insert molding, wire harness assembly, and testing—all under one roof.
Cleanroom assembly environment for sensitive medical products.
Certified to ISO 9001, ISO 14001, and IATF 16949, with processes aligned to ISO 13485 and IPC/WHMA-A-620.
Custom engineering support from prototype to mass production.
Global footprint – facilities in China, Mexico, and Morocco ensure flexible supply and local support.
By integrating tooling, molding, and assembly, TSP minimizes supply chain risks while maintaining world-class quality and cost efficiency.
Applications of TSP Medical Harness Solutions
Patient monitoring and imaging systems
Diagnostic analyzers
Surgical and robotic instruments
Life-support and respiratory equipment
Portable and wearable healthcare devices
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