Located in Thailand, the facility maintains a concentration of less than 100,000 particles (≥ 0.5 μm) per cubic foot of air and manufactures ISO 13485 compliant cables for medical and surgical purposes, used in operating rooms, hospitals, laboratories, and clinics. In this controlled environment, where microorganisms are at a specific level, pressure, temperature, humidity, and contamination levels are maintained within the limits defined by the standard.
Each cleanroom is equipped with HEPA (High-Efficiency Particulate Air) filters to prevent the spread of airborne organisms and viruses. In addition, the cleanrooms feature a positive pressure design, which prevents the entry of unfiltered air, while air showers remove particles attached to operators and products before they enter the cleanroom. Cleanroom maintenance includes microorganism counts to ensure compliance with cleanliness and bioburden levels. Medical cables, both surgical and non-surgical, are used in numerous applications: ablation, arthroscopy, coblation, cosmetic surgery, dentistry, electrosurgery, gastroenterology, laparoscopy, lasers, ophthalmology, power tools, surgical catheters, robotics, and video endoscopy.
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- Category: Electromedicine
ISO 13485 certified cables for medical and surgical purposes from their Class 100,000 cleanroom installation
Molex, LLC operates a fully certified cleanroom facility in accordance with the ISO 146441-1:1999 Class 8 standard, which meets the demanding contamination level requirements specified in the ISO standard.
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