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  • On-demand Webinar

Meeting FDA Expectations for ISO 18562

Learn test requirements and best practices for VOC and particle testing for medical devices from a UL expert.

Medical devices that should be considered for ISO 18562 VOC and particle testing

Overview of ISO 18562

US FDA 510(k) submissions must include data regarding the biocompatibility of any patient contacting (directly or indirectly) materials on all medical devices. For respiratory and ventilation devices, a key component of the biocompatibility evaluation is measuring chemicals and particles that may be released into the breathing gas pathway. 

Previously only general guidance was provided to define how manufacturers should measure and assess biocompatibility of the breathing gas pathway. The series of standards ISO 18562, Biocompatibility Evaluation of Respiratory Gas Pathways in Healthcare Applications, were formed to provide additional guidance and standardization for evaluating respiratory and ventilation devices.

What’s covered by ISO 18562

The test methods and risk assessment requirements in these standards apply to all medical devices, parts and accessories that may contact the breathing gas pathway. The scope of products effected by these standards include:

  • Ventilators
  • Anesthesia workstations (including gas mixers)
  • Breathing systems
  • Oxygen conserving equipment
  • Oxygen concentrators
  • Nebulizers
  • Low pressure hoses
  • Humidifiers
  • Heat and moisture exchangers
  • Respiratory gas monitors
  • Respiration monitors
  • Masks
  • Mouth pieces
  • Resuscitators
  • Breathing tubes
  • Breathing systems filters
  • Y-pieces

What you will learn in this ISO 18562 webinar

In this webinar, Scott Steady, a UL expert in environmental testing, will provide:

  • An overview of the ISO 18562 series of standards and the scope
  • Testing procedure and requirements 
  • Best practices for testing medical devices to the standard

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