For medical device companies as part of software validation, GR&R testing is required to prove that new software is capable of producing the same results as the previous software version. Instron conducted a series of tests to prove software equivalence between Bluehill 3 and Bluehill Universal as part of this validation process.
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This paper is intended to review the fundamental concept of Gage R&R studies also known as Measurement System Analysis (MSA). Different methods such as ANOVA and Xbar/R can be applied to conduct gage R&R analysis. The paper also presents case studies to understand applications of gage R&R in destructive testing and non-destructive testing and its significance with Instron systems. Furthermore, the concept of type I gage study also known is precision-to-tolerance ratio (P/T) is explained in detail here.
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This paper summarizes investigative testing performed to compare strain results obtained using Instron’s AVE and digital image correlation (DIC) to stress results obtained using Solidworks finite element analysis (FEA)
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The imminent release of ISO 6892-1:2016 will provide further clarification on the significant changes that were introduced in ISO 6892-1:2009, including the testing rates based on strain rate (Method A). To better clarify the requirements of Method A, ISO 6892-1:2016 now includes two clearly defined approaches, Method A1 (Closed-Loop Strain Control) and Method A2 (Constant Crosshead Separation Rate).
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Most approaches to strain measurement in Composites Coupon testing use contacting methods involving bonded strain gauges or clip-on extensometers. Recent developments in non-contacting strain measurement mean these systems now offer similar performance to traditional contacting systems, as well as providing significant other benefits such as the ability to provide full field strain maps.
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The FDA’s Medical Device 21 CFR 820 Quality System Regulation has multiple parts, including a subpart dedicated solely to equipment and facilities controls.The purpose of this review is to discuss laboratory controls pertaining to materials testing equipment.
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