Medical Device Testing News

MET is now able to provide the full gamut of testing required in ISO25539:2003 Cardiovascular implants. Testing covers both part 1: Endovascular Prothesis and part 2: Vascular Stents. Insertion forces can be measured as well as trackability and pushability for percutaneous devices. Radial outward force measurement and fatigue testing is carried out on the stents.

MET's supplier of blister tray sealing equipment, Belco Packaging Systems Inc., is celebrating its fiftieth birthday. Belco's medical tray sealers are robustly delivering perfectly sealed blister in factories around the world, day in day out. They are used for packaging a wide range of medical devices, from arthroscopy to orthopaedics

 

Shelf life claims validation forms part of a  comprehensive range of medical device and pack testing that is available from MET. A recent article in the spring edition of Med-Tech Packaging News by Mark Turner (MET) describes the application of these tests under FDA guidance.

 

"The testing for IV Bag for pressure decay last time was smooth and successful, we are satisfied by the prompt and detailed report." Honk Kong Pharmaceutical Company, QA Lab.

Fatigue testing, standards compliance, flow characteristics: a complete range of tests for heart valves is now available from MET. We examine valve opening pressures, forward flow, back flow, pulsatile flow and much more.

 

Stent delivery systems must deploy their cargo at the desired location. ASTM F2394 - 07 'Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System' is a guide to measuring the security of a stent on its balloon to ensure safe delivery. MET now provides comprehensive testing to this standard.

A new series of brochures describing medical device testing services is now available from MET. Titles include

Endovascular Device Testing

Heart Valve Testing

Stent Retention Force Testing

Stent Functional and Fatigue Testing

Contact MET for your copy.

8 June 2009

 

 

Medical device package stability testing requires both accelerated aging and real time aging studies to validate shelf life claims. MET is now offering real time aging studies in conjunction with accelerated test programs free of charge. Test programs include aging, integrity testing and seal strength testing.

 

The MET Vacuum Package Leak Test equipment is now available with extra precision. Making the leak integrity testing of tablet blisters and low viscosity fluid filled containers even more accurate.

 

 

Medical tray sealers have been evolving at Belco. They still retain the rigid structure and precise control, now with added interfacing options and control systems. These include: 

• Wireless Bar code scanning for the input of process data
• Data Acquisition of all characteristics for every seal cycle
• Networking of multiple machines for data recording

 

 

The medical device packaging machines from MET can now be seen on You Tube. The video footage shows a two lane glove packaging machine operating totally automatically at 60 cycles per minute.

http://www.youtube.com/watch?v=LsZverXFVjo

 

 Medical device leak testing equipment is now available for rental from MET.

This includes: pressure testing equipment, 'blue dye' testers and hydrogen trace gas testers

 

 

Hydrogen gas medical device and package leak testing equipment from MET has been upgraded. Version 5 of the Sensistor H2000 PLUS V5 has been released, delivering the highest sensitivity and best performance ever!

 

 

Engineers at MET have a wide variety of expertise in designing and testing medical devices. Our totally integrated platform allows us to combine design services using CAD and FEA, with knowledgeable risk analysis and functional testing. It does not stop there, as we can assess product performance against consensus standards and deliver all the data required for technical files and product approval. When required we also have in vivo facilities for phase 1 testing. Our regulatory consultants are on hand to help with CE marking and FDA submissions.

 Use our integrated design and testing services to save time and money, accelerate your medical device projects.

 

 

Heart valve testing services available from MET are now detailed on our latest web page. Test benches for custom and standard testing services are described. This is a comprehensive service covering all the requirements for mechanical and biological valves and novel delivery systems.

 Heart Valve Testing

MET is setting up to provide testing for walking aids, wheel chairs and mobility aids. Please let us know about your requirements.

At MET we have been expanding our laboratory equipment line up. We have invested in new tensile testing equipment and can now offer a maximum test force of 5kN with a displacement speed of 300mm per minute. In addition to peel testing, bond strength testing and product testing we can now also test standard plastic samples to ISO 527.

A full range of tensile and torque testing equipment is now available from MET. Fully calibrated gauges and test stands can be applied to a wide variety of test situations.

 Torque testing for: lid closure forces, catheter force transmission responses, tear open/ off forces and much more

 Tensile testing for: bond strengths, pack seal strengths, tubing strength and much more.

 Compression testing for: connector security, packaging security, actuator resistance and much more.

MET's medical device testing laboratory has moved to a new home. You will still get the same rapid, efficient service from our knowledgeable scientists and engineers.  Integration of our office and laboratory services reinforces our control systems and reporting efficiency.

 

The new laboratory is situated at:

 

Medical Engineering Technologies Ltd.,

Yew Tree Studios,

Stone Street,

Stanford North,

Ashford, Kent

TN25 6DH.
UK