When this applies
Every device in scope of ISO 18562 — ventilators, anaesthesia systems, breathing circuits, masks, humidifiers, CPAP and nebuliser tubing — needs the emission results read against the patient's inhaled dose, and ISO 18562-1 expects that assessment to be documented by a toxicologist. It applies to data from the 48-hour particulate, VOC and inorganics or VOC and inorganics studies, or from equivalent testing done elsewhere.
When to commission it
As soon as the gas pathway test reports are in, and before the submission is assembled. Allow three weeks from receipt of all inputs. Commissioning it together with the testing lets the toxicologist set the exposure assumptions — flow, duration, patient population — before the laboratory runs the study.
What you receive
A toxicological risk assessment in Groenakker’s template or yours covering: analysis and interpretation of the emission data; identification and grouping of compounds; derivation of dose-based toxicological thresholds for every compound or group above the analytical evaluation threshold, for the intended breathing duration and patient population; margin-of-safety conclusions; and a documented statement of residual risk. Signed by a DABT board-certified toxicologist.
What it does not cover
The base fee covers up to 25 compounds or compound groupings; beyond that, additional thresholds are priced in blocks of ten. The assessment does not address leachables into condensate (ISO 18562-4) or the ISO 10993 endpoints for parts that contact the patient directly, and it cannot see compounds the testing did not detect. Urgent requests — delivery in fewer than three business days from receipt — are billed at the standard hourly rate in addition to the base price, and work outside standard business hours (Monday to Friday, 8:00 AM to 5:00 PM ET, excluding observed holidays) at two times the hourly rate; both are subject to availability and confirmed in writing before work starts.
Method
A toxicological risk assessment to ISO 18562-1:2024 converts gas pathway emission results into inhaled dose and margin of safety for the intended patient and breathing duration. A Groenakker toxicologist reviews the ISO 18562-2 and -3 reports; converts emission rates into inhaled dose using the device's flow, duration and patient population; groups compounds; derives a tolerable exposure for each compound or group above the AET from the published toxicological data; and documents the margins of safety and conclusions. The report is reviewed and signed by a DABT board-certified toxicologist.
Who does the work
In-house at Groenakker. The assessment is prepared under Groenakker’s ISO 13485:2016 certified quality system and signed by a DABT board-certified toxicologist, and issued in Groenakker’s report template or in your document template on request at no extra cost.
Usually ordered alongside
The 48-hour particulate, VOC and inorganics (GRK-5001-04) or VOC and inorganics (GRK-5001-03) testing it reads, a biological evaluation plan covering the patient-contacting parts of the device, and the ISO 10993-17 assessment (GRK-2001) where those parts also have extractables data.
