ISO 13485 Certification – Y.C. Cable China

Y.C. Cable’s China manufacturing operation holds ISO 13485 certification supporting quality management requirements related to medical cable assembly and wire harness manufacturing.

ISO 13485 certification applies to the certified facility and the scope identified on the applicable certificate. Specific product, regulatory, inspection, testing, and documentation requirements should be defined for each customer program.

What Is ISO 13485?

ISO 13485 is an internationally recognized quality management system standard used by organizations involved in medical device and related manufacturing activities.

For OEM medical programs, a quality management system can support documented processes, production controls, traceability, inspection, and other customer-defined quality requirements.

Medical Cable & Wire Harness Manufacturing Support

Y.C. Cable supports custom medical cable assemblies and wire harnesses manufactured according to customer-approved documentation, which may include:

• Drawings
• Bills of materials (BOMs)
• Wiring diagrams and pinouts
• Connector and terminal specifications
• Material requirements
• Dimensions and tolerances
• Inspection criteria
• Testing requirements
• Labeling and identification requirements
• Revision-controlled documentation

Learn more about Medical Cable Assemblies and Medical Wire Harness Assemblies.

Project-Specific Medical Requirements

Medical cable requirements vary according to the finished device, application, operating environment, and customer specifications.

Requirements such as materials, cleaning, biocompatibility, sterilization compatibility, traceability, electrical testing, or other regulatory considerations should only be applied when specifically defined and approved for the individual program.

Quality, Inspection & Documentation

Inspection and testing are performed according to the approved manufacturing documentation and customer requirements.

Depending on the program, requirements may include dimensional inspection, visual inspection, continuity testing, pinout verification, electrical testing, material verification, labeling, and production documentation.

For current facility certification information, visit Y.C. Cable Certifications.

Discuss Your Medical Cable Project

For project review, please provide available drawings, BOMs, specifications, quantities, testing requirements, applicable quality requirements, and target schedule.

Request a Medical Cable Assembly Quote