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PRESS

Posted: April 19, 2018

Nelson Labs significantly expands lab operations and testing capabilities in Itasca, Illinois, to better serve customer needs

Nelson Labs significantly expands lab operations and testing capabilities in Itasca, Illinois, to better serve customer needs Nelson Labs doubles capacity for laboratory services at Itasca, Illinois lab location. Salt Lake City, UT, April 19, 2018 - Nelson Laboratories, LLC, a Sotera Health company, announced today that it has made significant investments to expand the operations and service capabilities at its Itasca, Illinois laboratory facility to better service customers.

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ARTICLE

Posted: June 25, 2018

How Clean is Clean Enough? Here are some takeaways from ISO 19227 for orthopedic implants.

By: Audrey Turley, Erin Bakes, and Matthew Jorgensen
Published: MD+DI

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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BLOG

Posted: June 20, 2018

The Risk-Based “Big Three”

Incorporating Biocompatibility, Chemistry, and Toxicology into your Biological Risk Evaluation In the past, biocompatibility consisted of determining the contact of your medical device, looking at the Table A.1 in ISO 10993-1 and running the test prescribed. This approach put too much emphasis on checking boxes of antiquated tests to screen the biocompatibility risk for modern-day […]

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VIDEO

Posted: June 12, 2018

MD&M East Tech Theater: The Future of Biocompatibility Industry Trends and Hurdles

The regulatory environment for the biological safety evaluation of medical devices is changing rapidly. Biological safety evaluations following ISO 10993 have traditionally been addressed with biocompatibility testing on animals; however, alternate options are now available to reduce animal testing by using literature research and chemical characterization tests when appropriate. Additionally, there has been considerable progress in the development and standardization of new in vitro test methods. New testing is available for gas pathway devices. Chemistry testing, toxicological risk assessment, and other written evaluations addressing biocompatibility have received wide acceptance. These alternative in vitro methods provide multiple benefits, including: less sample amount, less time required to perform the test, and reduced animal use.
 

  • How can a risk-based approach be used to address biocompatibility
  • How can material and chemical characterization be used to reduce testing burden
  • Update on development of alternative in vitro testing methods for irritation and sensitization

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