Connecting Across Competencies: Leveraging Best Practices for Processing

2021 ◽  
Vol 55 (s3) ◽  
pp. 6-11
Author(s):  
Terra A. Kremer ◽  
Kaumudi Kulkarni ◽  
Christopher Ratanski ◽  
Lorraine Floyd ◽  
Christopher Anderson
Keyword(s):  
Best Practices ◽  
Medical Devices ◽  
Technical Information ◽  
Test Sample ◽  
Positive Control ◽  
Standard Test ◽  
Test Method ◽  
Cleaning Validation ◽  
Validation Parameters ◽  
Method Suitability

Abstract The AAMI working group ST/WG 93 is finalizing a standard (AAMI ST98) for the cleaning validation of reusable medical devices based on guidance from the technical information report AAMI TIR30:2011/(R)2016. A number of analytical best practices are being considered for this new standard. Test method suitability for processing cleaning validations historically has been established using one positive control and performing an extraction efficiency. The new cleaning validation standard is proposed to require a change from only one replicate test sample to three when performing method suitability. This change will affect manufacturers; therefore, the value of and consideration for performing these additional replicates requires explanation. This article discusses how variation of validation parameters can affect the accuracy and precision during method suitability testing. Multiple replicates are needed to understand the variability of method extraction and impact on cleaning validations of reusable medical devices.

An evaluation of ECT sample height for small flute board grades and Box Manufacturer’s Certification compliance

TAPPI Journal ◽  
2009 ◽  
Vol 8 (6) ◽  
pp. 24-28
Author(s):  
CORY JAY WILSON ◽  
BENJAMIN FRANK
Keyword(s):  
Compressive Strength ◽  
Compressive Load ◽  
Test Sample ◽  
Test Methods ◽  
Test Method ◽  
Initial Development ◽  
Sample Height ◽  
Relationship Of ◽  
The Relationship ◽  
Corrugated Fiberboard

TAPPI test T811 is the specified method to ascertain ECT relative to box manufacturer’s certification compliance of corrugated fiberboard under Rule 41/ Alternate Item 222. T811 test sample heights were derived from typical board constructions at the time of the test method’s initial development. New, smaller flute sizes have since been developed, and the use of lighter weight boards has become more common. The T811 test method includes sample specifications for typical A-flute, B-flute, and C-flute singlewall (and doublewall and triplewall) structures, but not for newer thinner E-flute or F-flute structures. This research explores the relationship of ECT sample height to measured compressive load, in an effort to determine valid E-flute and F-flute ECT sample heights for use with the T811 method. Through this process, it identifies challenges present in our use of current ECT test methods as a measure of intrinsic compressive strength for smaller flute structures. The data does not support the use of TAPPI T 811 for ECT measurement for E and F flute structures, and demonstrates inconsistencies with current height specifi-cations for some lightweight B flute.

Microstructural Fractal Dimension of AISI 316L Steel

1994 ◽  
Vol 367 ◽  
Author(s):  
M. Hinojosa ◽  
R. Rodréguez ◽  
U. Ortiz
Keyword(s):  
Fractal Dimension ◽  
Grain Boundary ◽  
Grain Boundaries ◽  
Tensile Strain ◽  
Optical Microscope ◽  
Standard Test ◽  
Test Method ◽  
Aisi 316L ◽  
316L Steel ◽  
Deformation Processes

AbstractFractal dimension of the microstructure of AISI 316L steel (17 Cr, 12.7 Ni, 2.1 Mo, 1. 5 Mn, 0.01 C) with different degrees of strain were obtained from Richardson plots of grain boundary perimeter against magnification. Grain boundaries were revealed using conventional metallographic techniques and measurements were taken with the aid of an automatic image analizer (Quantimet 520) attached to an optical microscope. The magnifications used were 50, 100, 200, 400, and 1000X. The samples were obtained from a 4” diameter tubing, machined according to ASTM A370 standard test method and deformed to 5, 10, 15, and 20 % tensile strain. The results show that the fractal dimension of the grain boundaries changes as deformation is imparted to the material.These results suggest that fractal dimension may be used to describe microstructural evolution of metals during deformation processes.

scholarly journals Innovative Test Rig for Jet Fuels Thermal Stability Testing / Innowacyjne Stanowisko Badawcze Do Określania Stabilności Termicznej Paliw Lotniczych

2014 ◽  
Vol 29 (1) ◽  
pp. 15-22
Author(s):  
Jarosław Sarnecki
Keyword(s):  
Thermal Stability ◽  
Laboratory Test ◽  
Thermal Conditions ◽  
Standard Test ◽  
Test Method ◽  
Jet Fuels ◽  
Stability Testing ◽  
Test Rig ◽  
Standard Test Method ◽  
Laboratory Test Method

Abstract The article deals with laboratory test method for jet fuels thermal stability testing. Author described the reasons that led to test rig preparation, its construction and operation principles. Innovative test rig for jet fuels thermal stability testing enables research in wide thermal conditions and different pressures. Testing capabilities and advantages compared with currently used standard test method of jet fuels thermal stability testing according to ASTM D3241 have been also presented

Determination of Steady-State Adhesive Wear Rate

2005 ◽  
Author(s):  
L. J. Yang
Keyword(s):  
Steady State ◽  
Wear Rate ◽  
Wear Test ◽  
Standard Test ◽  
Test Method ◽  
Testing Time ◽  
Wear Coefficient ◽  
Wear Rates ◽  
Test Methodology

Wear rates obtained from different investigators could vary significantly due to lack of a standard test method. A test methodology is therefore proposed in this paper to enable the steady-state wear rate to be determined more accurately, consistently, and efficiently. The wear test will be divided into four stages: (i) to conduct the transient wear test; (ii) to predict the steady-state wear coefficient with the required sliding distance based on the transient wear data by using Yang’s second wear coefficient equation; (iii) to conduct confirmation runs to obtain the measured steady-state wear coefficient value; and (iv) to convert the steady-state wear coefficient value into a steady-state wear rate. The proposed methodology is supported by wear data obtained previously on aluminium based matrix composite materials. It is capable of giving more accurate steady-state wear coefficient and wear rate values, as well as saving a lot of testing time and labour, by reducing the number of trial runs required to achieve the steady-state wear condition.

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