White Paper

ISO 18562 Biocompatibility Evaluation of Breathing Gas Pathways

Mike Ludlow

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Mike Ludlow

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Market Development Manager for E&L at Element Life Sciences Manchester. 25+ years of pharmaceutical analysis specialising in trace impurity analysis and extractables and leachables.

In this white paper we deep-dive into the evaluation of biocompatibility for devices such as ventilators, breathing systems, nebulizers and respiratory monitors.

This content was authored by Mike Ludlow, Market Development Manager for extractables & leachables studies in Manchester. Mike has 25+ years of pharmaceutical analysis experience specializing in trace impurity analysis, and extractables & leachables.

The paper explains the importance of biocompatibility studies in the R&D stages of product development, and the significance of ISO 18562 as the framework to assess the risks associated with the breathing gas pathway products used for within healthcare.


The ISO 18562 family


Why download this white paper?

  • Learn about the origin of the standard and the medical devices it is relevant to 
  • Find out about the ISO 18562-1 risk assessment process
  • Gain insight into the four parts of ISO 18562
  • Understand the value of a trusted testing partner


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Mike Ludlow

About the author

As Market Development Manager at Element Life Sciences Manchester, Mike Ludlow has over 25+ years of pharmaceutical analysis specialising in trace impurity analysis and extractables and leachables.

Graduating as a chemist, Mike began his career in the analytical lab of a multinational chemical company, before focusing on NMR and LCMS in the spectroscopy area. Before joining Element in June 2023, Mike led an analytical function specializing in extractable and leachable testing, offering expert support globally.

Mike is dedicated to assisting our clients in bringing forward innovative products that enhance the well-being and comfort of patients.


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Watch our ISO 18562 Webinar

Watch our webinar for an in-depth overview of ISO 18562 testing, focusing on the bio-compatibility evaluation of breathing gas pathway devices. Nick Morley delves into the analytical methodologies essential for supporting this evaluation as per ISO 18562.

Failure to comply can result in costly recalls, potential harm to patients, and damage to a company's reputation and revenue. The webinar addresses these concerns by detailing the testing procedures mandated by ISO 18562 and highlighting real-world examples where inadequate testing led to significant repercussions.

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