Literature Library

Instron's Literature Library for Brochures, Manuals, White Papers, & Case Studies

FDA 21 CFR Part 11 Implementation - Bluehill Universal's Traceability Module White Paper

The purpose of this document is to inform the end user how the Traceability Module within Bluehill Universal can help meet the technical requirements of FDA 21 CFR Part 11. This document outlines the three key areas in Bluehill Universal (Security, Audit Trail, and Signatures) and also provides a row-by-row interpretation of how Bluehill Universal addresses each of the Part 11 items. Ultimately, each end user should perform their own assessment and create appropriate work instructions that cover the Instron system, Bluehill Universal, the Windows file systems, and the user’s Quality Management system.

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Whitepapers 4/26/2022 303.4 KB

Digital I/O Board Guide

The digital I/O board is an optional card which can be added to 5900 and 6800 frames. Digital communication, unlike analog, does not sense continuous signals but inputs or outputs of one of two states: high or low, open or closed. The card used in conjunction with the frame and Bluehill software allows the operator to trigger external or internal events. It allows for 4 input and output channels to be monitored and/or triggered simultaneously.

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Whitepapers 4/1/2020 475.7 KB

Steel reinforcement bar: A tensile testing guide

Steel rebar is commonly used around the world to reinforce concrete. Understanding the basics of rebar tensile testing is critical to ensuring product quality.

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Whitepapers 11/27/2017 2.0 MB

Analyzing performance of Universal Testing Systems using Process Capability Analysis

Manufacturers/OEMs are constantly striving to develop processes that will produce defect-free products. In this need for zero defect solution, experts strategize different ways to monitor process performances. One such metric is the Process Capability Analysis (PCA). The fundamental concept of PCA requires experts to understand variation of data from the pre-defined tolerance limits for an individual process. As Instron systems typically involve the process of testing and measuring, companies investigate this process’ consistency over multiple samples, over multiple batches and over multiple systems installed at different sites.

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Whitepapers 7/12/2017 186.6 KB

Equivalency Testing of Bluehill 3 and Bluehill Universal - a Statistical Review

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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Whitepapers 6/19/2017 368.5 KB

Instron Connect Architecture and Security Whitepaper

This document describes the architecture and security features of Instron Connect. It is intended to help business and technical decision makers understand how Instron Connect operates within your environment and how it meets your technical security requirements. Additionally, it addresses questions about key issues such as communication through firewalls and network security. The purpose of Instron Connect is to bring operators of Instron systems located anywhere connecting to Instron Connect, customers will experience greater system uptime, a streamlined support experience, and receive important notifications and software updates from Instron.

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Whitepapers 2/26/2017 251.9 KB

Understanding gage R&R concepts and its significance for Instron systems

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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Whitepapers 1/20/2017 399.5 KB

DIC FEA Whitepaper

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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Whitepapers 1/13/2017 134.0 KB

Strain Measurement Techniques for Composites Coupon Testing

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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Whitepapers 12/3/2015 0.8 MB

A Review of Medical Device Quality System Controls for Lab Equipment

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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Whitepapers 11/11/2015 400.7 KB

ISO 6892: Metallic Materials for Tensile Testing

The new ISO 6892:1-2009 (Metallic Materials - Tensile Testing - Part 1: Method of Test at Room Temperature) is a significant event for anyone performing tensile tests on metallic materials. The new standard replaces both the previous version of ISO 6892 and the widely-used EN 10002-1:2001 standard.

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Whitepapers 4/20/2015 380.1 KB

System Compliance and ISO 6892-1:2009 Method A

With the introduction of ISO 6892-1:2009, the principle of maintaining tight tolerances on the specimen strain rate during the test, to improve consistency of results, became more widely adopted. Previously, methods of this type had been mainly used within the aerospace industry. The method for maintaining the specimen strain rate in this manner is commonly referred to as “Method A”. The new ISO 6892-1:2009 standard supersedes both ISO 6892:1998 and EN 10002-1:2001, the testing procedures from these standards, stress rates with a strain rate limit, remained in what is known as “Method B”.

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Whitepapers 4/13/2015 138.5 KB

Rebar Tensile Testing Guide

Mechanical testing requirements for rebar can vary, but typically fall into the basic test categories of tensile, bend, compression, and fatigue. This document will focus primarily on the very common, yet sometimes challenging, tensile test.

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Whitepapers 3/31/2015 0.5 MB

Full Field Strain

With new and advancing materials being developed every day, research and material testing has to adapt to keep up. For materials research current strain measurement techniques do not offer enough information about how failures occur, and so, engineers are looking for different methods. One such test technique is the use of Digital Image Correlation (DIC) in measuring full field strain over a materials surface.

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Whitepapers 12/2/2014 492.3 KB

Composites Gripping Guide

A guide that provides an overview of the requirements and important issues that arise when gripping composite laminate coupons, as well as to outline multiple gripping solutions.

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Whitepapers 12/2/2014 2.1 MB

Gripping Effects in Composite Fatigue Testing

Gripping methods can significantly affect values and consistency of results in mechanical testing of composites. With a growing drive to measure and understand the dynamic behavior of composites, it is sometimes necessary to revisit previous methodologies for specimen gripping.

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Whitepapers 7/31/2014 1.0 MB

Characterizing Complex Materials with Impact Testing

During the European Congress on Composite Materials(ECCM16) seminar in Seville, Spain, Andrea Calzolari presented research that was carried out in cooperation with the University of Turin and the LIMA Corporate Group.

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Whitepapers 7/31/2014 0.7 MB

A Review of Contacting Strain Measurement Techniques for Composites Laminate Testing

The most common approaches to strain measurement in composites coupon testing involve the use of strain gauges bonded to the surface of the specimen or using a clip-on extensometer.

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Whitepapers 7/31/2014 2.1 MB