TRA · PDE03Toxicological Risk Assessment
Science-based TRA with quantitative exposure estimates, toxicological thresholds, Margin of safety, and comprehensive conclusions per ISO 10993-18 and 10993-17.
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ISO 18562-1:2024 Compliance
Biocompatibility for devices that deliver gas to the patient’s airway.
Overview
What is ISO 18562-1:2024 compliance?
Ventilators, anaesthesia systems, oxygen concentrators, CPAP devices, nebulisers and their accessories can release particulates and volatile organic compounds into the gas a patient breathes. ISO 18562 is the series that governs how this risk is evaluated.
We support the full ISO 18562 programme: biological evaluation planning, test strategy development, review of particulate, VOC and condensate leachable data, and toxicological risk assessment of every emitted substance.
Our assessments are aligned with ISO 18562-1:2024 and integrated with your ISO 10993 evaluation for components with other patient contact.
PMParticulate assessment
VOCEmission assessment
TRAEvery substance
When you need it
Typical triggers for this service
- Ventilators, anaesthesia and respiratory therapy equipment
- Oxygen concentrators and gas delivery systems
- CPAP, BiPAP and sleep therapy devices
- Masks, tubing, humidifiers and nebulisers
- Material or design changes in the gas pathway
What you receive
Deliverables
01Gas pathway categorisation and evaluation plan
02Test strategy for particulates, VOCs and leachables
03Review of laboratory protocols and data
04Toxicological risk assessment of emitted substances
05Patient population and exposure scenarios
06ISO 18562 biological evaluation report
Our approach
How we run the engagement
01
Pathway mapping
Identification of all components in the breathing gas pathway.
02
Evaluation plan
Exposure scenarios for adult, paediatric and neonatal patients.
03
Test strategy
Particulate (-2), VOC (-3) and condensate leachable (-4) testing.
04
Risk assessment
TRA of every substance detected above threshold.
05
Reporting
Integrated ISO 18562 and ISO 10993 conclusion.
Standards & guidance
Aligned with
ISO 18562-1:2024ISO 18562-2ISO 18562-3ISO 18562-4ISO 10993-1:2025ISO 10993-17:2023
FAQs
ISO 18562-1:2024 Compliance: common questions
Any medical device, part or accessory that provides gas to a patient’s respiratory tract, such as ventilators, anaesthesia equipment, oxygen therapy devices and their tubing and masks.
No. ISO 18562 addresses the gas pathway. Components with other patient contact, such as a mask touching the skin, are still evaluated under ISO 10993.
Emissions of particulate matter (part 2), volatile organic compounds (part 3) and leachables in condensate (part 4), followed by a toxicological risk assessment.
Related services
Often combined with this service
TRA · PDE03
ISO 10993-1:202501Biocompatibility Evaluation
Full biological safety assessment per ISO 10993-1:2025 for all device risk classes and patient contact types — from skin contact to long-term implants.
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Regulatory Compliance02BEP / BER Preparation & Review
End-to-end Biological Evaluation Plans and Reports — regulator-ready, audit-proof, and globally accepted by notified bodies and regulatory authorities.
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Need iso 18562-1:2024 compliance for your device?
Talk to a DABT · ERT · UKRT certified toxicologist about your biological evaluation. Direct expert response within 2 hours.
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