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Clarifying the Risk Management Requirements of IEC 60601-1, Third Edition

August 4, 2006 7:17 am | Comments

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.

Internal Form and Finish Critical to Manufacture of Heart Pump

August 4, 2006 7:17 am | Comments

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.

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Designing a Cleaning Efficacy Program for Reusable Devices

August 3, 2006 12:17 pm | Namsa | Comments

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.

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UV-C Detector

July 18, 2006 6:27 am | Comments

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.

Reciprocating Platform

July 10, 2006 10:13 am | Amacoil, Inc. | Comments

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&#151without changing the motor speed or reducing gears.

Parts Feeder

July 10, 2006 10:13 am | Comments

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.

Membrane Switch Solutions

July 10, 2006 10:13 am | Comments

Custom-built membrane-switch solutions with illuminated controls and a superior tactile response are offered to meet the needs of medical device manufacturers.

Medical Electrical Safety Analyzer

July 10, 2006 10:13 am | Comments

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.

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Custom Tubes/Rods

July 10, 2006 10:13 am | Comments

Custom manufactured surgical tubes and rods with burr-free custom slots, notches, cross-holes, multiple angles, and other complex features are available.

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Power Cords

July 10, 2006 10:13 am | Interpower Corporation | Comments

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.

Guidewire Tubing

July 10, 2006 10:13 am | Pexco, LLC | Comments

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.

Brushless DC Gear Motor

July 10, 2006 10:13 am | Micromo | Comments

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.

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Dispensing Valve

July 10, 2006 10:13 am | Comments

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.

Hydrophobic Coating

July 10, 2006 10:13 am | Comments

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.

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FireWire Cable

July 10, 2006 10:13 am | Comments

This high-flex 1394b firewire 800 cable is offered for the industrial vision systems market. The company developed the product&#151DataCELL MVC-800&#151to meet the requirements of camera installations in the more demanding factory environments.

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