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VOC and Particle Testing for Medical Devices

We offer testing and compliance assistance for manufacturers, helping ensure quicker U.S. Food and Drug Administration (FDA) 510(k) clearance for respiratory and ventilation devices and accessories.

Medical devices with breathing gas pathways

Medical device particle and VOC testing to meet ISO 18562

Our volatile organic compound (VOC) and particle testing services determine the biocompatibility of medical devices. International Organization for Standardization (ISO) 18562 testing is provided to the FDA as part of the 510(k) submission.

ISO 18562 is a series of international standards that outlines the general principles for the evaluation of the biological characteristics of medical devices used in respiratory care or to supply anesthesia or other substances through the respiratory tract. The ISO 18562 series provides you with a detailed framework for the comprehensive assessment of the biocompatibility of your medical devices with gas pathways. Testing in accordance with the technical requirements of the ISO 18562 series of standards can strengthen claims of biocompatibility in support of FDA 510(k) submissions.

UL's testing and exposure assessment services offer a thorough approach to assessing the compliance of medical devices with gas pathways with the requirements of the ISO 18562 series of standards. As prescribed by the ISO 18562 series, UL's comprehensive biocompatibility assessment includes testing for particles, VOCs and leachable condensates.

Benefits of an independent, third-party testing partner 

The FDA 501k medical device regulatory process

The regulatory approval process for medical devices is complex and not always well-defined. The FDA is the federal agency responsible for the regulatory oversight of medical devices in the U.S. Most medical device premarket reviews conducted by the FDA fall under its 510(k) Premarket Notification program. In addition to the device description, equivalent devices, software and performance testing information, the FDA 510(k) submission must include data regarding the biocompatibility of any patient contacting materials, directly or indirectly.

A new ISO 18562 biocompatibility evaluation

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

Medical device products affected

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 affected by these standards includes:

  • 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
  • mouthpieces
  • resuscitators
  • breathing tubes
  • breathing systems filters
  • Y-pieces
  • and many accessories

The enclosed chamber of an incubator, including the mattress and the inner surface of an oxygen hood, are considered to be gas pathways and are also addressed.

Our UL Environment team is an industry leader in chemical risk assessment, providing testing and compliance assistance for manufacturers to help ensure clearance of FDA 510(k) submissions for respiratory and ventilation devices and accessories.

Why UL for VOC and particle testing services

Our UL team is an industry leader in chemical risk assessment, providing testing and compliance assistance for manufacturers to help ensure clearance of FDA 510(k) submissions for respiratory and ventilation devices and accessories.

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