ISO 18562-3:2024

Overview

ISO 18562-3:2024 - "Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic substances" specifies laboratory tests and acceptance criteria to quantify volatile organic substance (VOS) emissions from the gas pathways of respiratory medical devices. The standard focuses on emissions that are added to the respirable gas stream by device materials (including VVOCs, VOCs and SVOCs) over the expected lifetime and after intended processing. It does not cover contamination originating from gas sources (pipelines, cylinders, room air) or biological surface-contact evaluation (see ISO 10993).

Key topics and technical requirements

• Scope of testing: Applies to gas pathways in ventilators, anaesthesia workstations, breathing circuits, oxygen concentrators, nebulizers, humidifiers, masks, incubator enclosures, oxygen hoods and similar respiratory accessories.
• Emission quantification: Tests are designed to measure volatile and semi-volatile organic compounds that migrate into the gas stream and reach the patient.
• Test method principles:
  • Devices set up per instructions for use; representative samples used after typical manufacturing/shipping delays.
  • Use of blanks and accessories to avoid interference; blank subtraction when necessary.
  • Testing at the highest clinically relevant ambient/operating conditions and over relevant lifetime/processing scenarios.
  • Selection of sampling and analytical methods guided by ISO 16000 series (e.g., ISO 16000-6) for active sorbent sampling and thermal desorption/GC-MS analysis.
• Risk-based evaluation: The tests are performed within a risk management framework (per ISO 18562-1:2024) to assess inhalation dose (concentration × breathing volume) and determine acceptability against established criteria.
• Reporting and acceptance criteria: The standard establishes reporting requirements and acceptance criteria for measured emissions.

Practical applications and users

Who benefits from ISO 18562-3:2024:

• Medical device manufacturers designing or validating respiratory devices and accessories.
• Regulatory and quality teams preparing biocompatibility documentation for conformity (including EU MDR considerations).
• Test laboratories performing emissions analysis for product verification and risk assessments.
• R&D and materials engineers selecting polymers, seals and components to minimize VOS emissions.

Practical uses:

• Pre-market biocompatibility testing of gas pathways.
• Material selection and supplier qualification to reduce patient exposure.
• Supporting risk assessments and regulatory submissions with standardized emissions data.

Related standards

• ISO 18562-1:2024 - Overall evaluation and testing strategy for breathing gas pathways (read in conjunction).
• ISO 10993 series - Biological evaluation of direct-contact surfaces (different scope).
• ISO 16000-3 / -4 / -6 - Methods for sampling and analysis of indoor/test chamber air (referenced normative methods).
• Mappings and regulatory cross-references (IMDRF, EU MDR) are provided in the standard’s informative annexes.

Keywords: ISO 18562-3:2024, biocompatibility, breathing gas pathways, volatile organic substances, VOC emissions, respiratory medical devices, inhalation dose, emission testing.