EN ISO 18562-3:2024 PDF

Overview

EN ISO 18562-3:2024 - Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic substances (ISO 18562-3:2024) specifies how to measure and assess emissions of volatile organic substances (VOCs) from the gas pathways of medical devices that deliver or monitor respiratory gases. The standard quantifies volatile, semi‑volatile and very‑volatile organic substances added to the respirable gas stream by device materials and establishes acceptance criteria for those emissions. It applies over the expected lifetime of the device and considers the effects of intended processing (e.g., cleaning/sterilization).

Key topics and requirements

• Scope of testing: Emissions from gas pathways of devices, parts and accessories used for respiratory care (e.g., ventilators, anaesthesia workstations, breathing systems, humidifiers, masks, incubator interiors).
• Emissions covered: VOCs, semi‑volatile and very‑volatile organic compounds introduced by materials of the gas pathway (note: contamination from the gas supply source is excluded).
• Test methods and measurement: Defines procedures to quantify emitted volatile organic substances and to determine inhalation dose; references relevant analytical methods (see related standards such as ISO 16000 series).
• Assessment of inhalation dose: Provides a framework to estimate patient exposure from measured emissions and to compare against acceptance criteria.
• Reporting and documentation: Specifies required reporting elements for test conditions, results and interpretations to support risk management and regulatory submissions.
• Lifecycle and processing considerations: Tests are to be representative of normal use over the device’s expected lifetime and consider intended processing (e.g., reprocessing or sterilization).
• Limitations: Does not evaluate biological effects of surfaces in direct patient contact (those are in the ISO 10993 series) and excludes contamination originating from medical gas sources.

Applications and who should use it

• Medical device manufacturers - to demonstrate biocompatibility of breathing gas pathways and to design/select low‑emission materials.
• Regulatory and quality teams - to support conformity with medical device regulations (e.g., EU MDR) and to provide evidence against General Safety and Performance Requirements.
• Test laboratories and contract test houses - for method implementation, VOC measurement and inhalation dose calculations.
• Clinical engineers and procurement - to compare devices based on emissions performance for sensitive patient groups (e.g., neonates).
• Risk managers - to integrate emission data into device risk assessments and post‑market surveillance.

Related standards

• ISO 18562-1:2024 - Evaluation and testing within a risk management process
• ISO 16000-3, ISO 16000-4 - Indoor air methods for formaldehyde and carbonyls (referenced for analytical sampling)
• ISO 10993 series - Biological evaluation of medical device materials (direct contact surfaces)
• EU MDR (Regulation (EU) 2017/745) - EN ISO 18562-3 includes an informative Annex ZA describing regulatory relationships

EN ISO 18562-3:2024 is essential for anyone assessing VOC emissions from breathing gas pathways and for demonstrating that respiratory devices meet contemporary biocompatibility and regulatory expectations.