Molex supplies medical grade surgical cables that meet ISO 13485 requirements using Class 100,000 clean room facilities

     Molex now operates clean rooms that are fully ISO 146441-1:1999 certified, meeting the strictly specified levels of particulate contamination required by ISO. With fewer than 100,000 (30.5mm) particles per cubic foot of air, the Thailand-based facility manufactures a wide range of ISO 13485-compliant medical and surgical cables for use in operating rooms, hospitals, laboratories and clinics. Its microbially controlled environment keeps indoor pressure, temperature, humidity, and contamination levels within the limits required by standards.

     Seann Kwan, product marketing Manager at Molex, said: "The introduction of microorganisms and other contaminants into the body, which can cause  harm to patients, makes disinfection control of medical devices a key component in the manufacturing process. "Iso-certified Class 100,000 cleanroom facilities allow us to provide medical device designers with cable assemblies that meet a wide range of international standards and regulations for medical devices used in vitro or in vivo by patients."

     Each clean room is equipped with a high Efficiency Air Particulate Matter (HEPA) filter to prevent the spread of airborne organisms and viral organisms. The filter also uses a positive pressure design to isolate unfiltered air from the outside of the room, while the air shower removes contaminated particles before workers and products enter the room.

     The audit and maintenance process of the clean room includes a count of microorganisms to ensure compliance with cleanliness and biological load levels. Medical grade surgical and non-surgical medical cables are suitable for a variety of applications, including ablation, arthroscopy, cryoablation, cosmetology, dentistry, electrosurgery, endoscopy, gastritis treatment, laparoscopy, laser, ophthalmology, power tools, surgical catheters, robotics, and endoscopy.