A question frequently asked about the required data rate to meet a given accuracy is: How many data points per second are required to characterize a test? Instead, the correct questions should be: 1) What is the bandwidth of the transducer conditioning system required in order to give an accurate measurement and 2) What is the required data rate?
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Use caution when comparing the values of a 180 degree peel adhesion test without understanding the test instrument’s bandwidth and data acquisition settings.
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Stents continue to evolve and continued material evaluation and development, as well as the delivery of new testing methods, is important for the evolution and success for these materials.
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When a testing system is subjected to a force, the entire system (frame, load cell, grips, etc.) deforms. The process of removing this deformation -- leaving only the results of the deformation of the specimen, is fully described in this whitepaper.
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The paper provides an overview of 21 CFR Part 11 as it pertains to materials testing, electronic records, and electronic signature procedures for industries regulated by the U.S. Food and Drug Administration (FDA). It describes the key elements of 21 CFR Part 11 and provides a methodology for transitioning your lab to a 21 CFR Part 11 compliant laboratory.
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