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From tmelectronics.com
When a manufacturing firm produces a product designated for use in the medical field, the company must supply one element regardless of part design: assurance. Through the use of in-line product testing and final package testing, a manufacturer can document the steps taken to assure the end user that the product has been examined and has passed the standard testing procedures designated by organizations such as the Food and Drug Administration (FDA), International Standards Organization (ISO), and American Society for Testing and Materials (ASTM). A quality control department, therefore, must be aware of different testing methodologies in order to gain this control and assurance over the production and packaging processes. This report examines different product and package testing procedures, focusing on the pressure decay leak and mass flow tests for product integrity and seal strength and pressure decay leak testing for package integrity. By implementing pressure decay leak testing, mass flow testing, and seal strength testing to a quality control system, a manufacturer of medical devices will gain control over their manufacturing process, and therefore gain quality assurance in the field. Products & Services
Leak testing equipment is used to measure the escape of liquids, vacuum or gases from sealed components or systems.
Material test fixtures and accessories include mechanical testing grips, fixtures, sample heaters, extensometers, specimen cutters, and other specialized test components.
Inspection services examine products, parts, equipment, repairs, services, installations, and facilities to ensure quality, consistency, and condition, as well as conformance to required standards and/or procedures.
Product and component testing services is the evaluation of a finished product or component through performance in electrical, life, environmental exposure, dynamic, ergonomic or other specialized tests. Also testing to standards such as UL 489, CE or MIL-STD 810.
RoHS testing and compliance services providers test a manufacturer's products for restricted or hazardous substances and certify compliance to RoHS or WEEE standards.
Product Announcements
Topics of Interest
Pressure decay is an established method of leak testing which involves the initial inflation of the test object and the establishment of a reference pressure. After a designated amount of time, the...
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Failsafe leak testing, where one never misclassifies a bad part as a good part, is doable. Better yet, good parts are never misclassified as bad parts and yield is maximized. However, this standard of...
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International Truck and Engine Corp. produces commercial trucks, mid-range diesel engines, school buses, chassis for motor homes and step vans, and diesel engines for the pickup truck, van and SUV...
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Testing flexible packaging for burst seal strength and creep resistance continues to be an important aspect in ensuring overall device integrity. An improved method of performing these tests involves...
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Horsham, Pennsylvania: Precision sealing of integrated circuit packages at high speed requires a backlash-free motion system to produce the highest quality seal. These systems have digital sealing...
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Technical Articles
Testing Medical Devices and Package Integrity (.pdf)
- Level Sensing
Implications for Process Package Testing in ISO 11607
- Level Sensing
Welding Miniature Devices
- Industrial Assembly
Better than metal
- Bearings and Bushings
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