ISO 27427:2023

Overview

ISO 27427:2023 - Anaesthetic and respiratory equipment - Nebulizing systems and components - defines safety and performance testing requirements for general-purpose nebulizing systems used to deliver liquids as aerosols to humans via the respiratory tract. It applies to continuous and breath‑actuated devices and covers gas-powered, electrically powered (spinning disc, ultrasonic, vibrating mesh, capillary), and manually powered nebulizers. The standard focuses on meaningful test methods and manufacturer disclosures but does not specify electrical requirements for electrically powered devices or set minimum performance thresholds.

Key topics and technical requirements

• Scope and definitions: Clear terminology such as aerosol, aerosol output, aerosol output rate, aerosol outlet port, respirable fraction (particles < 5 µm), and MMAD (mass median aerodynamic diameter).
• Performance testing: Type-test methods for aerosol output, aerosol output rate and particle sizing (see Annexes C and D). Calibration and test setup requirements are specified to ensure repeatable results.
• Materials and biocompatibility: Requirements for materials that contact liquids or the patient; alignment with risk management and biological safety evaluations (referencing ISO 18562-1).
• Design requirements: Inlet/outlet port specifications, flow-direction-sensitive components, rotary controls, and provisions for cleaning, disinfection or sterilization.
• Sterile supply and packaging: Requirements for devices supplied sterile, packaging, and marking of systems and packs.
• Information for users: Mandatory manufacturer information, labeling, instructions for use, performance disclosures, and driving gas supply data.
• Supporting guidance: Informative annexes include rationale (Annex A), particle diameter guidance (Annex B), hazard identification for risk assessment (Annex E), and device classification examples (Annex F).

Practical applications - who uses ISO 27427:2023

• Manufacturers of nebulizers and nebulizing components - to design, test and document device performance and safety.
• Test laboratories and conformity assessment bodies - to perform standardized aerosol output and particle sizing tests.
• Regulatory and procurement teams - to evaluate device documentation, claims and compatibility with clinical needs.
• Clinical engineers and biomedical teams - for selection, maintenance, cleaning/sterilization guidance and risk assessment of respiratory aerosol devices.
• Design engineers - to ensure material compatibility, port interfaces and flow-direction integrity.

Related standards (for context)

• ISO 18190 - general requirements for airways and related equipment (device‑specific requirements in ISO 27427 take precedence).
• ISO 18562-1 - biocompatibility evaluation for breathing gas pathways.
• ISO 80601-2-74 and ISO 20789 - humidification devices and nasal deposition (excluded from ISO 27427).
• ISO 20072 - drug-specific nebulizers (excluded).
• Other referenced standards: ISO 23328-1, ISO 80369-2, ISO 7396-1.

Keywords: ISO 27427:2023, nebulizing systems, nebulizers, aerosol output, aerosol output rate, particle sizing, respirable fraction, nebulizer testing, respiratory equipment.