ISO 18562 for Evaluation of Medical Device with a Breathing Gas Pathway

ISO 18562-1:2017 - Evaluation and testing within a risk management process

It covers general principles regarding biocompatibility assessment of medical device materials, which make up the gas pathway, but does not cover biological hazards arising from any mechanical failure, unless the failure introduces a toxicity risk (e.g., by generating particulates).

Points need to be considered for ISO 18562-1:2017:

• The general classification of gas pathways is based on the nature and duration of their contact with the gas stream.
• Analysing current relevant information from all sources
• The evaluation of the gas pathway's biological safety
• The identification of gaps in the data set that is currently available based on a risk analysis
• The identification of additional data sets is required to examine the biological safety of the gas pathway.

ISO 18562-2:2017 - Tests for emissions of particulate matter

ISO 18562-2 explains how to assess a medical device, its components, or accessories that are intended to administer respiratory care or deliver medications to a patient through the respiratory tract in any environment for particulate matter emissions through gas pathways.

PM2.5 and PM10 are the two sizes of particles that need to be measured. Both sizes refer to particles with sizes between 0.2µm and 2.5 µm and between 2.5 µm and 10 µm, respectively. Patients are more at risk from PM2.5 particles since they can subdue the body's natural defences. Their size enables them to enter the patient's lungs further, posing serious health hazards. The total mass of PM2.5 particles that are released cannot exceed 12µg/m3 of gas, according to ISO 18562-2. PM10 particles are less dangerous because they can't get as far into the lungs. They may yet potentially pose a risk to patients. According to ISO 18562-2, the maximum amount of PM10 particles that can be released is 150 µg/m3.

ISO 18562-3:2017 - Tests for emissions of volatile organic compounds (VOCs)

ISO 18562-3 describes testing for volatile organic compound (VOC) emissions from the gas routes of a medical device, its components, or accessories, which are designed to provide respiratory care or supply substances via the respiratory tract to a patient in any environment. The tests in 18562-3 are designed to measure the emissions of VOCs that the materials in the gas pathway add to the stream of respirable gases.

VOCs are organic molecules that have boiling temperatures between 50°C and 260°C at 101.3 kPa, which is the average atmospheric pressure. Patients who inhale gases while receiving treatment may be exposed to VOCs. Health consequences from these drugs may include irritation of the eyes, nose, conjunctiva, and throat, headaches, loss of coordination, nausea, vomiting, allergic skin reaction, dyspnea, exhaustion, and dizziness, as well as liver, renal, and central nervous system damage. They could potentially result in systemic disorders including blood clots, heart difficulties, and cancer.

Part 3 of ISO 18562 specifies how Respiratory Medical Devices (RMD) evaluations should be carried out, although it makes no suggestions for how VOCs should be collected and sampled. In general, two alternative analytical techniques are outlined for measuring VOC emissions: 1) emission sampling using sorbent tubes under ISO 16000-6 [6] or 2) canisters under ASTM D5466 [7]. For air monitoring and associated applications, these techniques are well-known and often used; tube-based methods, as described in ISO standard 16000-6, are favoured for evaluating emissions from goods and materials. [5]

Conclusion

To assess the biocompatibility of breathing components, three primary associated dangers (emissions of particulate matter, emissions of volatile organic compounds and leachable in condensate) are addressed in the March 2017 publication of the ISO 18562 standard for biocompatibility evaluation of breathing gas paths in healthcare applications. The criteria used to determine if a material or medical device is biocompatible with a breathing gas pathway are outlined in ISO 18562. Particulate matter emissions (PM2.5 and PM10), volatile organic compounds in a gas stream (VOC), and leachable in condensate must all be taken into consideration when it is anticipated that the gas channel may come into contact with the patient's respiratory system.

Decos has SMEs who can guide you with the ISO 18562 testing to assess the safety of your breathing device.

 

References
 

1. ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications 1: Evaluation and testing within a risk management process
2. ISO 18562-2:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications 2: Tests for emissions of particulate matter
3. ISO 18562-3:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications 3: Tests for emissions of volatile organic compounds (VOCs)
4. ISO 18562-4:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications-Part 4: Tests for leachable in condensate
5. How to sample and analyse VOCs of respiratory medical devices according to the new ISO 18562-3, Verena S. Aichner, Eurofins BioPharma Product, Pharm. Ind. 80, Nr. 10, 1423–1427 (2018)
6. ISO 16000-6, Indoor air – Part 6: Determination of volatile organic compounds in indoor and test chamber air by active sampling on Tenax TA® sorbent, thermal desorption and gas chromatography using MS or MS-FID, International Organization for Standardization, 2011
7. ASTM D5466: Standard test method for determination of volatile organic compounds in atmosphere (Canister sampling methodology), ASTM International, 2015.