Medical equipment wiring harness must not only meet electrical performance, but also pay attention to long-term reliability, material compliance and assembly cleanliness.Compared with general industrial wire harnesses, medical wire harness customization emphasizes "complete documents, traceable processes, and consistent delivery."
1) Demand confirmation: Turn "can be used" into "can be mass produced"
It is recommended to clarify before quoting: interface model, wire gauge/color, wire length tolerance, shielding/grounding method, bending resistance life, working temperature, whether alcohol/disinfectant resistance is required, and the assembly space and direction of the whole machine.
2) Materials and compliance: insulation, sheathing, and identification parts must be consistent
Common medical device requirements include flame retardancy, low odor, chemical resistance, and material consistency.For projects that require certification or customer-specified materials, proof of incoming materials/batch information should be retained to facilitate traceability.
3) Process control: crimping, welding, and bandaging must have standards
It is recommended to perform tension/section verification for crimping; control the temperature and solder joint appearance for welding; and consider both wear resistance and assembly space when selecting wrapping and sheathing.It is recommended to set up first article confirmation and inspection records for key processes.
4) Testing and traceability: not just conduction
In addition to continuity/short circuit, insulation, voltage resistance, shielding continuity, contact resistance, etc. can be added as required.For batch delivery, it is recommended to use barcodes/labels to connect "work orders - material batches - test results".
5) Delivery and change management
There are many "late changes" common to medical Wiring Harness: interface replacement, wire length adjustment, installation of fixed points, etc.It is recommended to manage version numbers for each change and update BOM, drawings and process documents simultaneously to avoid mixing old and new ones.
Conclusion
The core of medical wire harness customization is not "making it", but "making it stably".Only by establishing a solid system of requirements, materials, processes, testing and traceability can delivery be more worry-free.
Statement: This article is a summary of the process and precautions. Please refer to the equipment specifications and customer standards for specific requirements.