ISO 18562:

Biocompatibility Evaluation of Breathing Gas Pathway Devices

ISO18562 is the standard for biocompatibility evaluation of a material or medical device in in-direct contact with the breathing pathway. When the gas pathway is expected to connect the medical device and the respiratory tract of a patient, it is necessary to evaluate if contaminants are emitted from the device that can reach the patient. The contaminations can be particulate matter, Volatile Organic Compounds (VOC) and condensate that forms on the product that can reach the patient as droplets.

ISO 18562 was released in March 2017 to evaluate the biocompatibility of breathing gas pathways in medical devices. This four-part standard provides the framework to determine acceptability of medical devices that are in contact with the breathing gas pathways, including guidelines for clinically relevant flow rates.

Emmace Consulting has an extensive experience in evaluating inhaled and nasal drug products (OINDP) and is well equipped to perform testing of medical devices that are in indirect contact via the airways according to the ISO 18562 standard.

Emmace Consulting offers on a CRO basis:

  • Assistance in setting up a testing strategy to meet the requirements of ISO 18562.
  • Measure particulate matter emitted from your device using particle counter (PM2.5 and PM10; 2m-10m).
  • Analyse, quantify, and identify emitted VOCs using Gas Chromatography Mass Spectrometry (GC/MS).
  • Measure amount of condensate emitted from your device.
  • Assistance in generating and collecting condensate that can be sent for further analysis by the client for identification and quantification, in the generated condensate.
  • Interpret inhalation toxicity data relevant to breathing gas pathways for your device per ISO 10993-17 and ISO/TS 21726:2019.

We base the service on:

  • ISO 18562-1: Evaluation and testing within a risk management process.
  • ISO 18562-2: Tests for emissions of particulate matter.
  • ISO 18562-3: Tests for emissions of volatile organic compounds (VOCs).
  • ISO 18562-4: Tests for leachables in condensate, using clinical use conditions.
  • Toxicological Assessments.

These standards apply to all medical devices, parts, and accessories that may contact the breathing gas pathway.

Emmace Consulting is providing analytical services and advising on a CRO basis regarding testing and clearance according to these ISO standards.

Emmace Consulting is aiming for ISO17025 accreditation in fall 2021 for these methods.

If you find this interesting, please contact: elisabet@emmace.se to learn more or ask for a quotation.