Medical Industry
Medical Cable Solutions — ISO 13485 Compliant Cable Assemblies for Medical Devices
Nexharn supplies medical cable solutions for patient monitoring systems, diagnostic equipment, surgical instruments, and wearable medical devices. Our cables meet ISO 13485 quality management requirements and support biocompatibility compliance for Class I and Class II medical device programs.
Medical cable solutions overview
Cable Types for Medical Device Applications
Medical device OEMs and procurement teams require cable assemblies that combine electrical performance with biocompatibility, sterilization resistance, and regulatory traceability. Nexharn manufactures the following cable types for medical applications:
Quality & compliance
ISO 13485 Quality System and Biocompatibility for Medical Cable Manufacturing
Medical cable sourcing requires more than electrical performance. Device OEMs and procurement teams evaluate cable suppliers on quality system certification, material traceability, and biocompatibility documentation. Nexharn supports medical cable programs with:
- ISO 13485quality management system for medical device manufacturing
- ISO 10993biocompatibility material evaluation support
- IEC 60601-1electrical safety awareness for medical equipment cables
- Material traceabilitylot-level records for jacket, conductor, and connector materials
- RoHS / REACHrestricted substance compliance documentation
- First Article InspectionFAI report per PPAP-style documentation for new programs
ISO 13485 Compliant Manufacturing
Quality management system covering design, production, and inspection for medical cable assemblies
Medical cable specifications
Technical Parameters for Medical Cable Sourcing
When submitting an RFQ for medical cable solutions, include the following technical parameters to receive an accurate quotation and lead time estimate:
Electrical Requirements
Conductor size (AWG), conductor count, shielding type (braided, foil, or combination), impedance requirements, maximum current rating, and insulation voltage rating.
Environmental Conditions
Operating temperature range, sterilization method compatibility (autoclave, EtO, gamma radiation), chemical resistance requirements, and IP rating for connector interfaces.
Connector & Termination
Connector brand and model reference, pin count and pinout drawing, strain relief requirements, and overmold or boot specifications for each termination end.
Industry applications
Medical Device Sectors Served
Medical cable FAQ
Frequently Asked Questions — Medical Cable Solutions
Does Nexharn manufacture cables compliant with ISO 13485?
Yes. Nexharn operates under an ISO 13485 quality management system covering design input, production control, inspection, and traceability requirements for medical cable assemblies. We support first article inspection reports and material documentation for OEM customers.
What biocompatible jacket materials are available?
We offer TPU, silicone, PVC (medical grade), and TPE jacket materials. Each can be evaluated against ISO 10993 biocompatibility requirements. Material certificates and test reports are available upon request for OEM qualification programs.
Can you supply ECG lead wires and patient monitoring cables?
Yes. We manufacture ECG/EKG lead wires, limb clips, precordial leads, and multi-lead patient cables compatible with major monitoring platforms. Custom pinouts, connector types, and lead lengths can be specified via drawing or sample.
What is the MOQ for medical cable assemblies?
Standard MOQ for medical cable assemblies starts from 500 pcs. Lower MOQ is available for first article/prototype runs during qualification. Contact us with your program volume and we will advise on the most practical approach.
Do you provide First Article Inspection (FAI) reports?
Yes. Nexharn provides First Article Inspection reports covering dimensional checks, electrical testing, material certification references, and visual inspection records. FAI documentation can be aligned with your internal supplier qualification requirements.
Request a quote
Send Your Medical Cable RFQ to Nexharn
Include cable type, connector specifications, quantity, application environment, and any applicable standards (IEC 60601-1, ISO 10993, UL). Attach drawings or reference photos for fastest quotation.
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