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IQOQ Validation and Documentation (FDA 21 CFR 820)
Instron® Professional Services have provided onsite validation and
documentation services to support Installation Qualification/OperationalQualification (IQ/OQ) validation for many years. This service, provided by the original equipment manufacturer, is designed to ensure that your Instron testing equipment is suitable for its intended purpose and is capable of producing valid results (per FDA 21 CFR 820.72). Additionally,
you save time and resources by using Instron Professional Services to complete the IQ/OQ validation testing. Our experienced service team will use Instrons proven documentation pack that is tailored to your individual needs and contains necessary IQ/OQ documents, calculation work sheets,and manuals.
Services 08/07/2012 286.47 KB
CEAST HDT Vicat Series 3 and 6 Stations Testers
The effect of temperature on the mechanical properties of plastic
materials has a fundamental role in the design of components,
especially in the selection of materials. Unlike metals and ceramics,
plastics are extremely sensitive to the slightest changes in temperature.
The selection of plastics for applications under different temperatures
is a complex task. The material must be able to support a stress under
operating conditions without losing its strength and without critical
distortion. The effect of temperature on geometrical stability and
mechanical properties in general can be studied following different
procedures and methods like at constant temperature or with a
temperature ramp.
製品 06/19/2012 1.23 MB
Tensile Testing of Surgical Sutures
Sutures are used in a variety of different surgical procedures to close wounds and aid in tissue healing. They are manufactured from a variety of different absorbable and non-absorbable materials, and may be a single filament or braided with or without a coating. Tensile strength is a critical measure of performance during and after surgical procedures.
アプリケーション 05/10/2012 704.87 KB
Tensile Testing of Hypodermic Needles
Hypodermic needles are usually manufactured out of stainless steel and the material and design must be tested to evaluate the needle’s maximum tensile strength and yield strength.
アプリケーション 05/10/2012 286.42 KB
Compression Testing Syringes
Compression Testing Syringes tests the force necessary to eject medications from various types of syringes and needles.
アプリケーション 05/10/2012 182.82 KB
Tensile Testing of Soft Biological Tissues
With continued growth in the biomaterials market, characterization of the mechanical properties of soft tissues has become a rising interest. These properties allow for the understanding of tissue function and injury mechanisms, aiding engineers and researchers in the development of bio-engineered tissues, computer assisted and remote robotic surgical methods, and injury prevention recommendations. One of the challenges in testing soft tissues arises in gripping of the specimens.
Biological tissues are often times wet, slippery or delicate. Any
combination of these characteristics leaves the existing test methods far below the ideal gripping solution. The ultimate goal lies in the fixation of soft biological tissues without causing premature failure or slippage.
アプリケーション 05/10/2012 11.05 KB
Tensile Testing of Hydrogels In a Temperature-Controlled Bath
Hydrogels are widely used in the biomedical industry for applications such as coatings for catheters, contact lenses, scaffolds, and wound dressings because these materials have the ability to absorb fluids and swell up to 2000 times their original size. Hydrogels are often implanted into the body to provide medical benefits and therefore
アプリケーション 05/10/2012 577.67 KB
Tensile Testing of Nitinol Wire in Strain Control Using the AVE
The major challenge in testing Nitinol is accurate strain measurements. The crosshead position or LVDT reading does not provide the accuracy necessary to achieve specific strain criteria specified in ASTM standards.
アプリケーション 05/10/2012 402.75 KB
Advanced Video Extensometer (AVE) Marking Techniques for Soft Tissue Testing
Extensometers are often used to accurately measure the deformation of a material under mechanical loading. Due to the fragile nature of biological soft tissues, such as fascia, skin, and intestinal lining, a non-contacting extensometer is the ideal solution for measuring tensile strain in these specimens.
アプリケーション 05/10/2012 111.46 KB
Tensile Testing of Contact Lenses in a Temperature-Controlled Bath
Being the most widely used medical devices in the world Tensile Testing of Contact Lenses allows manufactures to obtain accurate data about the maximum and minimum strain of the material.
アプリケーション 05/10/2012 205.54 KB