Key International Standard Interpretation for Ultra-Fine Coaxial Cable Assemblies Used in Medical Devices

In the medical device field, cables are not only channels for signal transmission but also crucial for equipment stability and patient safety. Especially in high-precision equipment such as endoscopes, ultrasonic probes, and monitoring catheters, micro coaxial cables (extremely thin coaxial cables) undertake core tasks such as high-speed transmission, shielding, flexibility, and reliability. To ensure that these cables can meet the high safety, high stability, and international compliance requirements in medical scenarios, multiple international standards have become the basic guidelines for the industry.

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Medical Electrical Safety and Electromagnetic Compatibility Standards

The design and manufacturing of ultra-fine coaxial cable bundles must first comply with the safety standards for medical electrical equipment.

Among them, IEC 60601-1 is the most core electrical safety standard, covering requirements such as insulation performance, protection against electric shock, leakage current protection, and mechanical durability, ensuring that cables remain safe and reliable during long-term use.

Simultaneously, IEC 60601-1-2 proposes strict specifications for electromagnetic compatibility, including the ability to resist interference, static discharge, and suppress signal distortion, allowing the equipment to maintain stable operation in complex electromagnetic environments.

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Section 2: Production Quality System and Biocompatibility Requirements

The supply chain of medical devices is extremely focused on consistency and reliability, and the production process of ultra-fine coaxial cable bundles must comply with the ISO 13485 quality management system to ensure that the manufacturing process is controlled, the products are traceable, and the batch stability is high.
If cables need to come into direct or indirect contact with human tissues or body fluids, they must undergo ISO 10993 biocompatibility assessment to ensure that the materials will not cause toxic reactions, irritation, or allergies, thereby ensuring the safety of medical use.

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Three, connection performance and material safety standards

In order to adapt to the actual application environment of medical equipment, cables and their terminal connectors usually also need to meet various special standards:

• IEC 60512: Standard for the electrical continuity, mechanical durability, and environmental adaptability of connectors;

• AAMI EC53: Performance and safety requirements for cables used in ECG monitoring.

• UL 544: Ensure that medical device cables have reliable flame retardancy, insulation, and material safety.

These standards collectively constitute comprehensive protection for cable performance, enabling micro coaxial cable bundles to maintain stable performance under stringent conditions such as repeated bending, plugging and unplugging, movement, and sterilization.

In medical electronic equipment, micro coaxial cable not only undertakes the task of high-speed signal transmission but also directly affects the overall reliability, stability, and safety of the equipment. Only by strictly adhering to international standard systems such as IEC, ISO, UL, AAMI, can the cable meet the medical industry's requirements for high precision and high reliability.

I amSuzhou Huichengyuan Electronic TechnologyLong-term focus on the design and customization of high-speed signal cable harnesses and ultra-fine coaxial cable harnesses, committed to providing stable and reliable high-speed interconnection solutions. For further consultation or customization development, please contact Manager Yin.18913280527 (WeChat number)。