Nickel Tubing For Medical Devices

Compared with industrial grade nickel tubes, our medical device nickel tubes have significant advantages: they use exclusively developed medical grade nickel materials, and their biocompatibility test results are far superior to the requirements of ISO 10993 standard; By using special grain control technology, the pipe material has both excellent flexibility and pushing properties, making it particularly suitable for interventional medical devices; The cleanliness of the product meets the requirements of medical device packaging and can be directly assembled in the clean room. We can also provide adhesive performance data with various medical polymer materials such as PTFE and PeBax to help customers solve material assembly problems.

 

 

In addition to traditional interventional medical device applications, our nickel tubes are playing an important role in these emerging fields: as precision transmission tubes in robot assisted surgical systems; Serve as a sensor protective sleeve in continuous blood glucose monitoring equipment; Used as an electrode guide tube in neural stimulators; Serve as a coolant delivery pipe in dental implant equipment. We have also developed nickel alloy tubing specifically designed for MRI environments, with a magnetic susceptibility close to zero, which can completely avoid interference problems in strong magnetic field environments.

Proper processing and handling are crucial for maintaining the performance of medical device nickel tubes. It is recommended to use laser cutting or precision grinding wheel cutting for cutting to avoid the generation of metal debris; Cleaning must use medical grade cleaning agents and be carried out in ultrasonic cleaning tanks; Sterilization options include high-pressure steam sterilization (up to 134 ℃), ethylene oxide sterilization, or gamma ray sterilization. Our products have all passed relevant validation. When storing, the original packaging should be kept intact and stored in a clean environment with a temperature controlled at 25 ± 5 ℃ and a relative humidity below 60%.

We provide exclusive services for medical device customers: intervening from the product design stage to provide material selection support; Provide free material compliance consultation (including REACH, ROHS and other regulatory requirements); Assist in completing the technical documents required for medical device registration and application; We can provide exclusive production lines and batch reservation services for large orders. FAQ shows that customers are most concerned about the sensitization of nickel - in fact, our high-purity nickel tubes have undergone special passivation treatment on the surface to form a dense oxide layer, with a nickel ion precipitation rate of less than 0.1 μ g/cm ²/week, far below the standards required by the EU Nickel Directive.

Choosing us means choosing safety and reliability. As one of the few domestic manufacturers specializing in medical device grade nickel tubes, we have built a 100000 level clean workshop that meets GMP requirements and established long-term cooperative relationships with multiple Class III medical device manufacturers. Our products have been applied to high-end medical equipment such as pacemakers, intravascular catheters, and ophthalmic surgical instruments. We promise to provide lifelong quality traceability services and respond to any quality issues within 24 hours. Contact customer service now to receive a free sample package (including multiple specifications of medical nickel tube samples) and biocompatibility testing reports - let us use the highest standard medical device nickel tubes to provide a solid guarantee for your medical innovation.

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