We manufactured 1,500 precision sheet metal enclosures for in-vitro diagnostic (IVD) devices and minimally invasive surgical instruments. Built in a Class 8 cleanroom with 316L electropolished stainless steel, ±0.02mm ultra-high precision, and EMC shielding effectiveness ≥50dB. Compliant with ISO 13485, FDA 21 CFR Part 820, and ISO 10993 biocompatibility. Delivered five days ahead of schedule with zero failures across 300+ medical institutions worldwide.
Medical-grade precision sheet metal enclosures engineered for IVD devices and surgical instruments
From initial concept to final delivery – every detail of this custom fabrication project
With the global medical device industry advancing toward miniaturization, intelligence, and high reliability, a leading medical equipment manufacturer initiated a customization project for 1,500 precision sheet metal enclosures in 2026. These enclosures were designed for core components of in-vitro diagnostic (IVD) devices and minimally invasive surgical instruments, deployed in tertiary hospitals, independent laboratories, and mobile medical units worldwide.
The customer had been struggling with four recurring issues on medical device enclosures: mass production could not consistently achieve the ±0.02mm dimensional tolerance required for sensitive sensor and circuit board assembly, traditional sheet metal production introduced particle contamination that failed cleanroom requirements, electromagnetic interference compromised diagnostic data accuracy and surgical instrument operation, and surface finish color varied between batches affecting the professional medical aesthetic.
The core engineering challenge was achieving four simultaneous requirements at medical-grade standards: maintaining ±0.02mm dimensional tolerance across 1,500 units while controlling material deformation during processing, ensuring zero particle contamination in a Class 8 cleanroom environment throughout all production stages, achieving EMC shielding effectiveness ≥50dB through optimized enclosure structure and conductive coatings, and controlling surface color difference to ΔE ≤0.8 across all batches of electropolished and anodized components.
We adopted a “pre-deformation compensation + real-time monitoring” strategy: FEA simulation set pre-compensation parameters for cutting and bending, while online vision inspection systems monitored key dimensions in real time, achieving 100% dimensional pass rate. The production workshop was upgraded to Class 8 cleanroom standards with air purification, closed workpiece transfer, and anti-static cleanroom protocols, achieving ≤100 particles/m³. EMC performance was optimized through conductive gaskets at body-cover joints and full-surface conductive nickel plating, reaching ≥50dB shielding. Automated surface treatment with unified raw material batches and a color management system achieved ΔE ≤0.6 across all 1,500 units.
All 1,500 medical enclosures passed CMM dimensional inspection (0.001mm precision, 100% inspection), sealing tests (0.3MPa for 30 minutes, zero leakage), EMC testing (radiated emission ≤30dBμV/m), 1,000-cycle alcohol disinfection resistance tests, and third-party biocompatibility verification (cytotoxicity, skin irritation) with a 100% pass rate. Delivered five days ahead of the 40-day deadline. After 12 months of deployment in 300+ medical institutions worldwide, the enclosures showed zero cases of corrosion, contamination, or EMC failure, effectively guaranteeing stable medical device operation.
Sanjun achieved the ±0.02mm precision our previous vendors said was impossible at scale, and their Class 8 cleanroom production eliminated the contamination issues that caused our last product recall. The EMC shielding is exceptional – our diagnostic devices operate with zero interference, and the electropolished 316L surface withstands daily hospital disinfection without any degradation. Their deep understanding of medical industry regulations and strict compliance with ISO 13485 and FDA standards made them the obvious long-term partner. We have signed a 3-year agreement for three new medical device lines.
Eight reasons global brands partner with SanJun Hardware for precision sheet metal fabrication
Medical device quality management system with full traceability and documented processes at every stage.
Streamlined scheduling and capacity planning ensure your orders ship when promised.
Expert design-for-manufacturing review at no cost – optimize your design before production.
Dimensional ±0.02mm and laser positioning ±0.01mm – medical-grade accuracy across every batch.
Class 8 cleanroom with air purification and closed transfer – zero particle contamination.
CMM 0.001mm inspection, sealing tests, EMC testing, and biocompatibility verification.
Prototypes from 1 unit to production runs of 10,000+ – scalable capacity to match your needs.
Work directly with our engineering team – fast responses, clear updates, no middlemen.
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