PRODUCT UPDATE
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Dynatek Dalta
Proprietary equipment is customized to meet specific testing requirements by a company that analyzes heart valves and vascular and drug-eluting stents. Dynatek Dalta (Galena, MO, USA) offers performance and durability testing of heart valves to verify compliance with ISO 5840 and tests stents to ensure compliance with ISO 25539-1. Other capabilities include high-speed photographic verification of device motion, radiographic device inspection, and scanning electron microscopy.
Standard and custom mock vessels for device testing are available to allow researchers to study devices under a variety of environmental conditions. The vessels are routinely used for flow studies, deployment studies, and durability testing. The firm can produce comprehensive test reports suitable for inclusion with regulatory submission documents.
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Uson
A leak tester suitable for a variety of bottles and canisters used in the medical and pharmaceutical industries is available from a company with more than 40 years of experience developing leak detection equipment. The Qualipak-B 752 from Uson (Bury St. Edmunds, Suffolk, UK) enables repeatable, nondestructive testing that allows normal packaging to be returned to the assembly line and the contents of leaking packages to be reclaimed. Test chamber infills enable a variety of container sizes to be tested.
The leak tester can accommodate containers measuring up to 6 in. diam; custom chambers can be developed. The units have an anodized aluminium chamber and base. A PCMCIA card slot is provided in the device for memory storage, touch screen input, and pressure plot graphics.
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Associated Research
A data-interface card for a company’s electrical safety testers enables a choice of communication protocols and provides a quick and efficient method for logging test data in production lines where connecting to a PC is impractical. Available from Associated Research (Lake Forest, IL, USA), the interface card for the Omnia and HypoUltra III includes a serial port, a data-collection port, and a PS/2 input. The serial port can be configured for RS-232 and RS-485 interfaces.
The data collection port works directly with a 256-Mb flash memory card, which can store 100,000 test results. Test data are automatically stored at the end of each test. These data include a time and date stamp, the model and serial number of the testing instrument, and test file numbers. The user of the instrument can choose to recall all test results or only pass or fail results.
A bar code scanner inputs the model and serial number of the device being tested. The data are then stored in the data interface card’s internal memory. Users can initiate test programs that are saved in the testing instrument’s memory, and can recall saved test programs using the bar code scanner.
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NAMSA/Biomatech S.A.
Preclinical and clinical testing of medical devices can determine the efficacy, biocompatibility, and sterility of finished products. NAMSA/Biomatech S.A. (Chasse-sur-Rhône, France) offers a comprehensive range of testing and consulting services designed to help manufacturers meet international regulatory compliance standards. In addition, the company offers biological and chemical indicators, growth promotion test suspensions, and sterilization indicator inks that are suitable for sterilization monitoring.
The multinational firm’s laboratory in France provides functional and performance testing, physical and chemical characterization, and histopathology, biocompatibility, and microbiology services. Clinical trial supervision and in vitro and in vivo safety evaluation studies are also available. In addition, the firm offers sterilization and packaging validation, environmental monitoring, and shelf-life studies.
Melab GmbH
A range of equipment has been developed for testing the compliance of medical disposables to ISO standards. Examples of products from Melab GmbH (Leonburg, Germany) include a luer torque tester and luer reference gauge along with instruments designed to test cannulae for sharpness, friction, and penetration forces.
Using polyurethane to simulate human skin and blood vessels, the firm can determine mechanical properties such as the force that will need to be applied before a device will kink, bend, or break. Syringes can be tested to determine the force required to move the plunger forward or backward and to ascertain leakage in accordance with ISO 7886.
The company also designs a range of in-line equipment. In addition to machine vision and leak testing units, it can provide testing stations for cannulae assembly and syringe filling lines.
Certified to ISO 9001, the firm can provide laboratory services and written reports suitable for inclusion with device master files.
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Rigel Medical
An analyzer was designed to test medical products for compliance with industry standards including IEC/EN 60601-1, MDA DB9801, and IEC/EN 61010 in a single test routine. The 277 Plus unit from Rigel Medical (Peterlee, Co. Durham, UK) can handle manual, automatic, and semiautomatic test sequences. The user is able to fully control the number of power-up and power-down delay to speed up test routines.
The unit includes a number of operating features to help increase traceability, and it has sufficient memory to support numerous test sequences. The instrument’s serial number is automatically transferred with test results, and menu shortcuts allow rapid data transfer between the Rigel 277 Plus and internal or external printers or PCs.
The unit is available with an evaluation copy of MediGuard Plus asset management software and a range of accessories including a carrying case. The firm also offers portable biomedical test equipment, including electrical-safety analyzers, ventilator testers, NIBP and SpO2 simulators, defibrillator testers, and patient simulators.
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IMST GmbH
Accredited electromagnetic compliance testing and related services are available from a company that specializes in developing custom wireless applications for customers in the medical device and other industries. IMST GmbH (Kamp-Lintfot, Germany) has expertise in the use of wireless technologies such as Bluetooth, ZigBee, GSM/GPRS, UMTS, and WLAN. However, it also makes available to customers a fully accredited test centre that includes anechoic chambers, shielded rooms, and a range of communications measurement equipment.
Certified to ISO 9000:2000, the firm uses anatomically correct body models to predict the electromagnetic field strength in human tissue.
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Sensistor
A leak detector suited for medical products uses diluted hydrogen as a tracer gas. The tracer gas is injected into the test object, and a handheld probe connected to a leak detector uses an audio signal to indicate leaks. The instrument was developed by Sensistor (Linköping, Sweden).
Hydrogen is used as a tracer gas because it is the lightest element and has a higher molecular velocity and lower viscosity than air or helium. In addition, hydrogen is nontoxic and has no adverse effect on the environment. The use of diluted hydrogen—it is mixed with nitrogen—results in a mixture that is classified as nonflammable according to ISO 10156.
Hydrogen leak detection can be used for a variety of medical applications such as implants, balloon catheters, collection bags, blood bags, IV bags, and parenteral bags. Capable of detecting leaks dimensionally smaller than bacteria, the instrument can carry out tests with short cycle times, regardless of temperature variations or the shape of the test objects.
Unlike traditional multistep methods for leak detection, hydrogen-based leak detection allows seamless testing of medical bags by simplifying the process into one step, improving productivity and efficiency. The instrument releases a harmless mixture of hydrogen and nitrogen into the bag, causing it to inflate. Once the bag is inflated and the leak has been identified, the bag is deflated to its original shape. The relatively low gas pressure eliminates the need for bag restraint and minimizes the possibility of causing damage to the sample.
The probe can be equipped with a protective cover to allow leak detection of wet objects. Standard settings on the instrument can be changed using the user-friendly display menu. To test a medical device automatically, specific test modules are available that can be interfaced with test fixtures to quantify the total amount of leakage from the device.
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PBI-Dansensor
A permeability tester is designed to provide reliable oxygen and water-vapour transmission rate measurements. The testing device from PBI-Dansensor (Ringsted, Denmark) can measure water vapour permeability from 0.03 to 10,000 g/m2/24 hr. Unlike testers that measure extractive values, the unit includes a sensitive humidity sensor with a linear, dynamic range that measures samples directly within the test chamber. The testing process measures the time required for the upper-chamber humidity to increase within a predefined interval caused by the permeation of water vapour through the test film or foil. This static test protocol approximates natural conditions and does not require extractive sampling or the use of a carrier gas.
The company also develops and services modified-atmosphere packaging instrumentation. The firm’s product range includes on- and off-line gas analyzers, gas mixers, leak detectors, and flow controllers. The analyzer line includes an O2 and O2/CO2 headspace gas analyzer and a handheld gas analyzer for O2 or O2/CO2 with a memory function for spot testing.
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IDM Instruments
A coefficient of friction tester can determine the static and kinetic friction of plastic film, paper, and other sheeted material. With an optional computer software package, the device from IDM Instruments (Dandenong, Australia) provides a fast, reliable, and accurate method of determining friction in various manufacturing areas.
The IDM COF features data acquisition software that enables users to display results in real time. The option of displaying results in grams or as a coefficient of friction is also provided.
Before a test is performed, users can choose to autoscale graphs. The software allows onscreen observation of the graph during the test. Once a graph is recorded, it can be saved in an Excel spreadsheet.
The company also designs and manufactures a range of other physical testing equipment suited for quality control and R&D applications. It is certified to ISO 9001.
