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Author: Robert Haley





October 1, 2018

Understanding Worst-case Conditions in ISO 18562 Testing

For three decades, the ISO 10993 international standard series has provided the overarching guidance on evaluating medical devices for biocompatibility. The new international standard, ISO 18562, addresses gaps. Here’s what you need to know. Read Full Story

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September 1, 2018

Reusable Medical Devices: BI Selection, Overkill Validation Approaches, and First-Time Validation Pass Rates in Common Healthcare Steam Sterilization Cycles

When validating the steam sterilization instructions for a reusable medical device, first-time pass rates are important to manufacturers. Failures in validation testing require resolution, adding to the total validation time, which can result in a delay to regulatory submission, getting...

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May 12, 2014

ASTM Committee Meeting Updates for F02 and D10

Robert Haley, Packaging Department Manager, Nelson Labs The American Society for Testing and Materials International (ASTM) Committee Meeting for F02 and D10 committees was recently held in Lansing, Michigan.  During the F02 meeting, there were discussions for potential round robin...

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