ISO 18562-3 defines acceptable methods for determining VOC emissions released into the gas stream within respiratory medical devices. These are then converted to patient exposure levels, for comparison against specified thresholds of toxicological concern.
Devices covered by ISO 18562-3
ISO 18562-3 contains a comprehensive (but not exhaustive) list of medical devices, parts and accessories that contain gas pathways, and which need to be tested.
These include ventilators, anaesthesia workstations, oxygen-conserving equipment, nebulisers, gas monitors, masks, mouthpieces, breathing tubes and any breathing accessories intended to be used with the medical devices.
ISO 18562-3: Tubes or canisters?
ISO 18562-3 references two possible methods for sampling emissions – sorbent tube sampling in accordance with ISO 16000-6, or canister sampling in accordance with ASTM D5466.
Both methods are well-established and popular for air monitoring and related applications. However, we would generally recommend the tube-based method ISO 16000-6 for medical device testing, because of the broader analyte range and greater practicality of sorbent tubes.
Method-compliant tube-based sampling
Tube-based sampling in accordance with the ISO 16000-6 method stipulated in ISO 18562-3 requires that gas is purged through the respiratory medical device onto a sorbent tube.
The tube is then analysed by thermal desorption in conjunction with GC–MS/FID, which allows determination of the levels of VOCs present.
Complying with ISO 18562-3
From the above summary, it will be clear that Method TO-17 places considerable demands upon the equipment used for sampling and analysis.
Markes’ UNITY-xr and TD100-xr thermal desorbers comply fully with the requirements of ISO 18562-3 and the associated method ISO 16000-6. We also offer a range of supplies and equipment to assist with this application.
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