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US FDA Recognizes ISO 18562 Biocompatibility Standard for Medical Devices

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Medical device regulators at the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) have officially recognized a series of ISO standards for volatile organic compounds (VOC) and particle testing as consensus standards.

US FDA recognized consensus standard ISO 18562 medical device biocompatibility 2018Specifically, FDA has recognized the ISO 18562 Biocompatibility evaluation of breathing gas pathways in healthcare applications. This means that US medical device market registrants whose products affect breathing gas pathways may now utilize ISO 18562 testing and declarations in their premarket submissions, potentially reducing regulatory review timeframes.

Benefits for devices for use in respiratory applications

Leveraging ISO 18562, manufacturers can demonstrate reduced risk of patient exposure to toxic levels of chemicals in devices that include breathing gas pathway components.

“Although some materials and components of devices with respiratory applications may pose minimal risk in general-use products, that risk may increase if those materials or components interact with breathing gas pathways for patients,” explains Scott Steady, Senior Product Manager at UL Environment.

“Testing and toxicology evaluation according to the ISO 18562 standards will help manufacturers objectively demonstrate safety of patient breathing airstreams in their devices, patient interfaces and accessories.”

Medical device types covered by ISO 18562

ISO 18562 testing and risk assessment methods cover all medical devices, component parts and accessories that contact or interact with breathing gas pathways. Examples of device types falling under the standard’s purview include:

  • Ventilators
  • Nebulisers
  • Mouthpieces
  • Anesthesia workstations
  • Low-pressure hoses
  • Resuscitators
  • Breathing systems
  • Humidifiers
  • Breathing tubes
  • Oxygen conservation equipment
  • Heat and moisture exchangers
  • Breathing system filters
  • Oxygen concentrators
  • Respiratory gas monitors
  • Y-pieces
  • Incubators
  • Masks
  • Accessories

Related resources for medical device registration and testing requirements:

  • UL ISO 18562 VOC and particle testing for medical devices
  • US FDA 510(k) consulting for medical device and IVD companies

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