Originally Published July 2000
SPOTLIGHT
Testing Equipment and Services
Label claim support
One- and two-cell mouse embryo tests are available to support label claims made by manufacturers of reagents, supplies, or medical devices used in conjunction with assisted reproductive techniques (ART) and related procedures. Toxicity of ART-related medical devices such as catheters, culture dishes, needles, syringes, gloves, reagents, and culture media may result in embryotoxicity or malformed offspring. All devices submitted to FDA for clearance that bear label claims for use in ART must use the mouse embryo assay for lot-to-lot release. ART procedures include in vitro fertilization, artificial insemination, embryo transfer, gamete intrafallopian tube transfer, intracytoplasmic sperm injection, and zygote intrafallopian tube transfer. NAMSA, 2261 Tracy Rd., Northwood, OH 43619.
Compliance services
Certification for manufacturers exporting medical devices to the European Union is available from a company that provides product certification and quality management system assessment. The company can certify manufacturers' compliance with the European Medical Device Directive, the Active Implantable Medical Devices Directive, and, most recently, the In Vitro Diagnostic Directive. These services encompass all testing procedures and audits based on the EN 46000 and ISO 9000 series of standards. TÜV Rheinland of North America Inc., 12 Commerce Rd., Newtown, CT 06470.
High-current ground bond tester
A ground continuity tester performs to CE, IEC, and TÜV requirements for production line testing. The newly redesigned Model GF-30AC provides 25-A-ac constant current to any ground circuit with resistance of 0 to 0.1 W. The unit features one-button operation; a red or green light indicates pass or fail test results. A NEMA 5-15R receptacle on the front panel provides maximum flexibility for direct connection of the product or a custom test lead. Compliance West USA Inc., 4206-A Sorrento Valley Blvd., San Diego, CA 92121.
Residual strain measurement
A complete line of manual and automated equipment is available for evaluation of residual stress and polymer orientation in transparent and translucent plastics. Quantitative nondestructive test methods prevent product failures such as cracking, warping, shrinking, and distortion without the use of chemicals, heat, or layer removal. Products range from strain viewers and polarimeters to PC-based automated stress scanners. Strainoptic Technologies, 108 W. Montgomery Ave., North Wales, PA 19454.
Material-testing software
Material-testing software can be used on a personal computer for data acquisition, control, analysis, and presentation. Used with the supplies test systems, the C-TAP test acquisition package performs ASTM, ISO, DIN, and other standard or custom tests in a PC environment. Data, charts, and specific ASTM results can be displayed in graphic and table formats. Com-Ten Industries, 6405 49th St. N., Pinellas Park, FL 33781.
Flexible-pack integrity tester
Nondestructive flexible-pack integrity testing for single and dual package forms is available. The Q700 tester can detect holes as small as 12.5 µm in packages as large as 8.5 x 10.5 x 4 in. The operator loads the package into the test module and closes the lid, which initiates an automated preprogrammed test cycle. At the completion of the test, either a green (pass) or red (reject) light turns on, based upon the variable limits preset into the unit's memory. A display provides information concerning setup parameters, result details, and testing statistics. ITI Qualitek, 267 Boston Rd., North Billerica, MA 01862.
Nonporous package tester
A package tester verifies the integrity of nonporous, flexible packages. The Test-A-Pack F100-2700-2 consists of a digital control console and a package test chamber. The control console automatically regulates the vacuum source while providing test data on the display screen. By adding water to the test chamber for submersion testing, the exact location of any package leak can be pinpointed by observing the stream of bubbles. Carleton Technologies Inc., 10 Cobham Dr., Orchard Park, NY 14127.
Independent testing laboratory
Orthopedic product testing services are available to support regulatory approval and product development. For example, the test center performed the servo-hydraulic fatigue tests needed to obtain IDE approval from FDA for the Christensen TMJ prosthesis system (shown here). All testing follows client-approved protocols using specific product standards published by ASTM and ISO and is in compliance with GLPs. Product testing involving the use of cadavers or environmental exposure can be accommodated. Harrington Arthritis Research Center, 300 N. 18th St., Phoenix, AZ 85006.
Helium leak detection
Helium mass spectrometry can be used to test a variety of medical devices for leaks. The machines can be configured to test one or more products simultaneously or alternately. Multiple stations can be installed to achieve in-line production-rate testing. Automatic sorting of parts is available as well as complete test information for statistical process control. Uson L.P., 5215 Hollister, Houston, TX 77040.
Leak test system
A dual-fixture leak test system can check two cast-aluminum parts. The parts may be tested individually or asynchronously. Parts are manually loaded and the sealing and test sequences are initiated by depressing a pair of palm buttons. Throughput is projected at 120 parts per hour with a leak rate of 0.12 ml/min. The company will supply custom part fixturing and has a complete line of leak, flow, and volume testers. Samsomatic Ltd., 45759 Helm St., Plymouth, MI 48170.
Spot-curing system tester
A handheld instrument measures the intensity in watts per square centimeter emitted by a spot-curing system. The SpotCure UV intensity meter is operated by inserting the light guide into one end of the unit and pushing the start button. The meter then measures and displays the peak intensity up to 19.99 W/cm2. With light guide adapters, the measurement head containing the optics can accommodate any size light guide. SpotCure can measure several different wavelengths including 250–260, 280–320, 320–390, or 395–445 nm. EIT Inc., 108 Carpenter Dr., Sterling, VA 20164.
Liquid sample analysis
A versatile mass spectrometry system for liquid sample analysis enables the user to identify new drug candidates, support combinatorial chemistry activities, and determine metabolites and breakdown products of pharmaceuticals. The Jaguar benchtop time-of-flight mass spectrometer has rapid acquisition rates of up to 100 spectra per second across a large mass range. The unit has detection limits of 500 attomoles or better and accurate mass measurement to within 10 ppm. The Jaguar also features a data management system that includes total recovery compression algorithms without loss of data integrity. Leco Corp., 3000 Lakeview Ave., St. Joseph, MI 49085.
X-ray inspection system
An x-ray inspection system is suitable for continuous operation in high-volume medical device facilities. X-rays pass through the sample and are detected by an x-ray–sensitive image intensifier, producing a visible image on the output phosphor. The image, which is relayed into a high-resolution CCD video camera and passed through an image processor, is displayed on the system monitor in real time. The unit requires a single 110- or 240-V-ac supply. Lixi Inc., 1438 Brook Dr., Downers Grove, IL 60515.
Bottle cap torque tester
The required application or removal torque of bottle caps can be measured with a digital torque sensor. The Model STB also performs breakaway- fastener, motor-stall, valve-operating, and tool-calibration torque measurement. The unit features a universal gripping mechanism and is splashproof. It connects to the Model BGI force/torque indicator to provide results on a 4½-digit LCD. Other features include a multifunction set of annunciators, peak torque memory, selectable units and automatic shutoff, and a 9-V rechargeable battery or ac operation. Mark-10 Corp., 458 W. John St., Hicksville, NY 11801.
Universal test machine
Quality assurance of products, materials, and adhesives for high-volume applications is available from a universal test machine. The 200Q provides tensile and compression testing at controlled speeds from 0.002 to 50 in./min. The unit is capable of testing up to 200-lb loads with the standard load cell. Lower-force load cells are available for tests below 10 lb. DDL Inc., 9675 W. 76th St., #110, Eden Prairie, MN 55344.
Production safety analyzer
A production safety analyzer is designed for fast and easy testing of medical electronic products and instruments. The Guardian 6100 performs five electrical safety tests in accordance with UL, CSA, and IEC standards such as UL 2601-1, UL 1563, UL 1950, and UL 544. The unit can perform ac hipot tests from 50 to 5000 V, dc high-pot tests from 50 to 6000 V, insulation resistance measurements from 100 kW to 50 GW, and line/earth leakage measurements from 0.1 µA to 9.999 mA. QuadTech Inc., 100 Nickerson Rd., Marlborough, MA 01752.
Video metrology systems
A series of video metrology systems may be used for critical measurement and high-precision positioning of parts and products during manufacturing and quality control inspection. The DataStar 200 and 300 systems incorporate new, ergonomically designed workstations. The Galaxy metrology software package optimizes setup time and measurement and analysis of critical-part data. The DataStar 100 continues to be available as an individual component or with a new metrology stand and table. The company is ISO 9001 compliant. RAM Optical Instrumentation, 1791 Deere Ave., Irvine, CA 92606.
Microlens-testing system
An automatic microlens-testing system is designed to measure parameters of microoptical components as small as 0.5 mm diam with consistent accuracy of 5 µm. The Optomatic-Micro's measurements are controlled and evaluated by a computer, and results can be printed or stored to file. Applications include testing of microobjectives, intraocular lenses, and optics for endoscopes. Mildex Inc., 1388 Crittenden Rd., Rochester, NY 14623.
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