Overview
XinHarness manufactures cable assemblies for diagnostic, monitoring, and bench-top medical equipment in a segregated Medical Division, separate from our general industrial production, with lot-controlled materials and design-history-file documentation for each part number.
Design & Construction
Biocompatible Materials
Insulation and jacketing are selected from FEP, PVC, or medical-grade silicone depending on patient-contact requirements, with ISO 10993 biocompatibility documentation available on request for patient-contact assemblies.
Connector & Strain Relief
Overmolded or potted strain relief is applied at connector interfaces to withstand repeated flexing and cleaning cycles typical of hospital and clinical environments, with locking connector options for critical-care equipment.
Manufacturing Process
Production follows a validated process under our ISO 13485 quality system, with incoming material lot control, in-process electrical testing, and finished-goods inspection recorded against each device’s design history file.
Typical Applications
- Patient monitoring equipment
- Diagnostic and imaging equipment
- Laboratory and bench-top analyzers
- Infusion and fluid-delivery devices
- Hospital-grade power and signal cabling
Common installations include Patient monitoring equipment, Diagnostic and imaging equipment, and Laboratory and bench-top analyzers, where biocompatibility, electrical safety, and continuous fail-safe operation are the primary design drivers. The same base design can also be adapted for Infusion and fluid-delivery devices and Hospital-grade power and signal cabling with minor changes to connector type or cable length.
Technical Specifications
Standard configurations are available with the following technical specifications; custom configurations outside these ranges can be discussed with our engineering team. Wire Gauge: AWG 34 – 18. Conductor Count: 2 – 40 conductors. Insulation: FEP / PVC / Silicone (biocompatible options). Temp Range: -20°C to +105°C. Voltage Rating: Up to 250V AC (isolated circuits available). Cleanroom: ISO Class 100,000 (ISO 8). Biocompatibility: ISO 10993 data available on request.
Quality & Certification
Manufactured under ISO 13485:2016 and ISO 9001:2015 certification, with FDA 21 CFR Part 820-aligned process controls and IEC 60601-1 compatible construction available for equipment-level compliance. Material certificates and ISO 10993 test data are supplied for patient-contact materials.
Customization & Lead Time
Standard lead time for the Custom Medical Device Cable Assemblies is 4–6 weeks prototype, 2–3 weeks production. Connector type, cable length, and conductor configuration can be customized to match your exact application, including connector type, cable length, and sterilization compatibility to match your device’s specific design requirements. Contact our engineering team with your drawings or requirements for a project-specific quote.
Why XinHarness
Our Medical Division supports Class II and Class III device OEMs from prototype through validated production, with cleanroom manufacturing kept separate from general industrial harness work. Visit our Medical industry page for full certification detail, or request a quote for your project. For related technical background, see our article on the role of potting and conformal coating in wire harnesses.
Frequently Asked Questions
Medical assemblies including the Custom Medical Device Cable Assemblies are manufactured under ISO 13485 quality management for medical device manufacturing.
Yes, biocompatible and autoclave-sterilizable materials are available depending on the application and device contact requirements.
Yes, connector type, cable length, shielding, and sterilization compatibility can all be tailored to your specific medical device requirements — share your design specifications for a custom quote.
