Guidelines that aid medical device manufacturers in the regulatory approval process are welcomed resources for engineers. The third edition of the IEC 60601-1 integrates risk management into the previously accepted safety standards for medical electrical equipment.
The Project: Verify that geometry and surface texture of the housing for a heart pump will facilitate smooth functioning while not adversely affecting blood. The Solution: Use extremely accurate instrumentation to measure form and surface to ensure they are compliant with specifications.
There have been a number of changes in the last decade, which have raised questions as to how manufacturers should design cleaning and sterilization validation in order to be in compliance with new standards.
The low drift solid-state ROD-360-UV18 detector has been developed specifically for the measurement of effective ultraviolet germicidal irradiance applied in air and water sterilization applications employing low and medium pressure Hg or pulsed Xenon lamps.
This reciprocating linear motion platform is driven by a rolling ring drive which reciprocates automatically without requiring motor reversal. Using a control knob on the assembly, adjustments to linear speed are also possible on-the-fly—without changing the motor speed or reducing gears.
The compact DS1100 uses an over/under conveyor design to feed parts in trays to conveyor-fed automated workstations. This tray indexing design reduces the machine's footprint so it takes less floor space, while improving workflow.
Custom-built membrane-switch solutions with illuminated controls and a superior tactile response are offered to meet the needs of medical device manufacturers.
The Rigel 266 plus is a highly compact, easy-to-use medical electrical safety analyzer designed to test in accordance with IEC/EN 60601-1, MDA DB9801, and AS/NZ 3200.
Custom manufactured surgical tubes and rods with burr-free custom slots, notches, cross-holes, multiple angles, and other complex features are available.
The Swiss 16A power cords and cordsets are for equipment rated up to 16A with service at 250 VAC. They are approved to SEV, Electrosuisse SEV 1011:98, CH-Type 23, Standard-Sheet SEV 5934-2. The power cords and cordsets are available from stock with 1.50 mm 2 HAR cable in 2.5 M length.
A unique two-layer extruded medical grade tubing has been developed that allows guidewires used in vascular procedures to be inserted into the tubing faster and more efficiently, thereby reducing labor cost.
The 1307 BH brushless gear motor has a diameter of 13 mm and a length of 7 mm and can achieve a continuous torque of 5 mNm with speeds up to 1,639 RPM.
The VMP30H is a multipurpose, mini-poppet pneumatic valve designed for controlled dispensing of low to high viscosity materials, such as silicones, RTV, epoxy, rubber adhesives, greases, and filled materials.
A hydrophobic coating for plastics was designed to compliment the company’s proprietary diagnostic adhesive, GL-187. The coating can be successfully applied to polyester, polystyrene, vinyl, and other plastics for IVD and a variety of other medical applications.