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How Clean is Clean Enough?

Here are some takeaways from ISO 19227 for orthopedic implants. By: Audrey Turley, Erin Bakes, and Matthew Jorgensen
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 device manufacturers address the cleaning of their devices. One of the requirements of the good laboratory practices (GLPs) mandated by FDA is that medical devices be free from manufacturing residuals. Determination of what is needed to fulfill this requirement has largely been up to manufacturers and has been a topic hotly debated across the industry.

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