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Author: Erin Bakes





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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June 25, 2018

How Clean is Clean Enough?

Here are some takeaways from ISO 19227 for orthopedic implants. ISO 19227 Implants for Surgery–Cleanliness of Orthopedic Implants–General Requirements is a long-awaited guidance document that was finalized and published early 2018. This guidance document is intended to assist orthopedic medical...

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March 10, 2017

Single Use & Newly Manufactured Device Cleaning Validations

Performing a cleaning validation during the initial phase of a device’s lifecycle aids manufacturers in complying with current good manufacturing practices (CGMP) and quality system (QS) regulation as set forth by FDA for medical device manufacturers. The data gathered during...

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August 27, 2013

TOC Testing Verifies Acceptable Levels of Organic Carbon

Total Organic Carbon (TOC) is a very sensitive test that helps medical device manufacturers in two main areas: (1) ensuring USP and EP standards for water quality are met, and (2) validating the cleanliness of single-use and reusable medical devices. TOC...

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