In the development and manufacturing of medical devices, medical sheet metal processing plays a crucial role. Whether it’s the parts of diagnostic equipment that directly contact patients, the housings that protect the internal precision components, or customized sheet metal for special models, all these must strictly adhere to the medical industry’s high standards of "safety, compliance, and precision." Unlike standard industrial sheet metal processing, the core value of medical sheet metal processing lies in using standardized processes and customized adaptations to provide solid support for the stability, sterility, and compatibility of medical devices.

Core Industry Requirements for Medical Sheet Metal Processing: Why Is It Different from Standard Sheet Metal?

Medical devices are directly related to patient health and diagnostic safety, which means that medical sheet metal processing must follow industry standards far higher than those for standard sheet metal. These requirements are not only the foundation for ensuring compliance and reliability of the devices but also the cornerstone for guaranteeing the safe operation of medical equipment.

1. Strict Compliance Certification

Medical sheet metal processing must not only comply with international standards but also meet the specific, high standards required by the medical industry. The most crucial certifications include the ISO 13485 medical device quality management system and the GMP pharmaceutical manufacturing quality management standards. During the manufacturing process, every detail must be rigorously recorded—such as material traceability, process parameters, and inspection reports—to ensure that each piece of medical sheet metal can be traced throughout its lifecycle. This is essential for meeting regulatory requirements for the full lifecycle of medical devices. In contrast, standard industrial sheet metal processing typically follows standards like ISO 9001, without the need to undergo the specialized compliance audits required in the medical field. Therefore, there are fundamental differences in process control and quality management between the two.

2. Micron-Level Precision Control

The internal spaces of medical devices are often very compact, requiring sheet metal components (such as housing interfaces and internal support frames) to perfectly fit with circuits, sensors, and other precision components. The dimensional tolerances in medical sheet metal processing must typically be controlled within ±0.1mm, with high-precision CNC laser cutting and bending technology being key to achieving this accuracy. For example, if the position of cooling holes in a diagnostic device housing deviates by more than 0.2mm, it could prevent the installation of cooling fans, affecting the device's cooling efficiency and potentially causing malfunctions. This level of precision is far higher than what is typically required in standard industrial sheet metal (usually a tolerance of ±0.5mm), and it is a core technical requirement that must not be overlooked in medical sheet metal processing.

3. Medical-Grade Material Selection

Medical sheet metal components, especially those in direct contact with patients or within sterile environments, must be made from materials that are biologically compatible and corrosion-resistant. For example, medical device housings are often made of 304 or 316L medical stainless steel, which is not only easy to clean and resistant to disinfectant corrosion but also meets the sterility requirements of environments like operating rooms and laboratories. For lightweight diagnostic devices, such as portable ultrasound machines, 6061 medical-grade aluminum alloy is often used to ensure strength while reducing device weight and improving portability. In contrast, standard sheet metal often uses cold-rolled steel or regular aluminum alloys, which do not offer sufficient corrosion resistance or may release harmful substances, making them unsuitable for medical environments.

Key Application Scenarios: Special Requirements for Medical Device Housing Processing

The housing of medical devices is not just a protective shell but also bears multiple responsibilities such as sterile operation, device compatibility, and patient experience. Medical sheet metal processing must ensure that the housing meets high standards in these three areas.

1. Sterility and Easy-to-Clean Design

Medical device housings need to avoid hygienic dead zones, ensuring that they are easy to clean and maintain a sterile environment. The surface flatness of the housing is crucial and is usually achieved through precision polishing and brushing, ensuring that there are no protrusions or seams that could trap dust or liquid. All corners of the housing must be rounded (radius ≥1.5mm) to avoid injury to medical staff or patients and to allow cleaning tools to reach all surfaces. Additionally, the protection level of the housing must be adjusted based on the application environment, with surgical room devices typically needing to meet IP65 (dustproof and waterproof) standards.

2. Device Compatibility and Adaptation

The design of the housing must not only consider appearance and material but also allow for precise interfaces and installation locations to ensure compatibility between the internal components and external accessories. For instance, the diameter tolerance of electrical connection holes must be controlled within ±0.05mm to ensure a tight fit for power and data cables, avoiding poor connections. Moreover, for core components like displays and sensor modules, custom support frames need to be designed to ensure the parts remain secure after installation and to minimize vibration and noise during operation.

3. Safety and Stability

The housing must not only ensure structural strength but also withstand impacts and transport vibrations in medical environments. For example, the housing of critical care equipment is typically made from 1.5-2mm stainless steel, while general diagnostic equipment often uses 1-1.2mm aluminum alloy, balancing both strength and lightness. To ensure the long-term stability of the housing, the welding process is particularly important. Medical sheet metal processing often uses laser spot welding or argon arc welding, with the weld spot diameter controlled to ≤3mm. This prevents welding deformation that could affect the housing's precision and ensures the welds are corrosion-resistant, preventing rust and failure after long-term use.

Medical Sheet Metal Customization: The Key to Adapting to Diverse Medical Devices

The variety of medical devices, with their different structures and functions, makes it difficult for standardized sheet metal components to meet all requirements. Therefore, medical sheet metal customization becomes the key solution to this challenge. The customization process focuses on the following three critical stages:

1. Design Collaboration and Process Optimization

In the early stages of customization, deep collaboration with device manufacturers is necessary to optimize the design based on CAD drawings provided by the client. For example, if the design involves bending angles that could lead to cracking (e.g., <90°), the designer may recommend an adjustment. For complex perforated structures, CNC laser cutting is often recommended to reduce mold development costs and shorten customization lead times.

2. Early Integration of Compliance

During the customization process, compliance requirements must be integrated into the design and manufacturing stages. For example, if the customized sheet metal component is in direct contact with patients (such as a support arm for rehabilitation equipment), materials that have passed biological compatibility testing must be selected, and the testing reports must be retained. Additionally, surface treatments must avoid coatings containing heavy metals, and anodizing (for aluminum alloys) or passivation (for stainless steel) is preferred to ensure compliance with medical environmental standards.

3. Sample Verification and Batch Control

Before mass production, custom orders require the production of samples, which must undergo triple verification. The first step is dimension verification, using a three-coordinate measuring machine to check the critical dimensions of the sample. The second is functional verification, ensuring compatibility of interfaces, heat dissipation performance, and structural stability. Finally, compliance verification involves checking material reports and process records to ensure that the sample meets standards like ISO 13485.

Medical Sheet Metal Processing: Ensuring the Reliability and Safety of Medical Devices

Medical sheet metal processing is not just about "precision" and "appearance"—it also plays a critical role in ensuring the safety and stability of medical devices during use. Through strict compliance control, precise processing techniques, and customized design services, medical sheet metal processing provides solid assurance for the safe operation of medical devices. In this process, the safety of patients and the convenience of medical staff during operations are always the top priorities.