White Paper

ISO 18562 Biocompatibility Evaluation of Breathing Gas Pathways

Mike Ludlow
By Engaged Expert Mike Ludlow

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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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Download our ISO 18562 biocompatibility evaluation white paper for free

Learn more about the importance of biocompatibility studies in the R&D stages of medical product development.

We delve into the four parts of ISO 18562 and how effective studies help support product compliance and reduce delays to market.


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