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
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.
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 start a conversation from the homepage.
