ISO 27427-2023 PDF

Full title and description

ISO 27427:2023 — Anaesthetic and respiratory equipment — Nebulizing systems and components. This international standard specifies safety and performance testing requirements for general-purpose nebulizing systems and their components used to deliver liquids as aerosols to the human respiratory system.

Abstract

This document defines test requirements and considerations for gas-powered, electrically powered (e.g., spinning disc, ultrasonic, vibrating mesh, capillary) and manually powered nebulizers intended for continuous or breath‑actuated aerosol delivery. It excludes devices intended solely for nasal deposition, devices intended only for humidification/hydration, and drug‑specific inhalation devices. The standard does not set minimum performance limits and does not specify electrical safety requirements for electrically powered nebulizers.

General information

• Status: Published
• Publication date: July 2023
• Publisher: International Organization for Standardization (ISO)
• ICS / categories: 11.040.10 (Anaesthetic and respiratory equipment)
• Edition / version: Edition 4 (2023)
• Number of pages: 33

Key bibliographic and lifecycle data as published by ISO.

Scope

Applies to general‑purpose nebulizing systems intended to deliver liquids in aerosol form to the respiratory system for humans. Covers a range of power sources and nebulizer technologies and sets out safety and performance test methods and requirements for systems and components. Explicitly excludes nasal‑only devices, devices solely for humidification/hydration, and drug‑specific inhalation devices (see normative references for related standards).

Key topics and requirements

• Definitions and classification of nebulizing systems and components.
• Test methods for aerosol generation, output rate, droplet/particle size characterization and consistency of delivery.
• Safety requirements covering mechanical, pneumatic and material aspects relevant to respiratory use.
• Requirements and instructions for labelling and information supplied by the manufacturer.
• Exclusions and normative references to related respiratory device standards (electrical safety requirements are not specified here).
• Performance verification procedures and documentation expected for conformity assessment.

Typical use and users

Used by medical device manufacturers, test laboratories, product designers, regulatory compliance teams, quality managers and procurement specialists involved with anaesthetic and respiratory equipment. Applicable where manufacturers need to demonstrate safety and performance of general‑purpose nebulizing systems for clinical or home‑use respiratory delivery (excluding drug‑specific delivery systems and humidifiers as noted).

Related standards

Related and cross‑referenced standards include ISO 80601-2-74 and ISO 20789 (covering some humidification and respiratory device aspects) and ISO 20072 (drug-specific inhalation devices). ISO 27427:2023 sits within the ISO/TC 121/SC 2 committee work on anaesthetic and respiratory equipment.

Keywords

nebulizer, nebulizing system, aerosol delivery, respiratory equipment, anaesthetic equipment, vibrating mesh, ultrasonic nebulizer, spinning disc, aerosol testing, ISO 27427

FAQ

Q: What is this standard?

A: ISO 27427:2023 is an international standard that specifies safety and performance test requirements for general‑purpose nebulizing systems and components used to deliver liquid aerosols to the human respiratory tract.

Q: What does it cover?

A: It covers test methods and requirements for a broad range of nebulizer types (gas‑powered, electrically powered, manual), addressing aerosol generation, delivery consistency, safety of components and required manufacturer information. It excludes nasal‑only devices, pure humidifiers/hydration devices and drug‑specific inhalers.

Q: Who typically uses it?

A: Medical device manufacturers, R&D and design engineers, testing laboratories, regulatory and compliance teams, and procurement groups involved with respiratory or anaesthetic equipment.

Q: Is it current or superseded?

A: ISO 27427:2023 is the current edition published in 2023 and supersedes the earlier ISO 27427:2013 edition (the 2013 edition was withdrawn when the 2023 edition was published).

Q: Is it part of a series?

A: It forms part of the body of ISO standards for anaesthetic and respiratory equipment developed under ISO/TC 121/SC 2 and is cross‑referenced with related standards (e.g., ISO 80601‑2‑74, ISO 20789, ISO 20072) that address adjacent device types and specific test requirements.

Q: What are the key keywords?

A: Nebulizer, aerosol delivery, respiratory equipment, anaesthetic equipment, aerosol testing, vibrating mesh, ultrasonic nebulizer, ISO 27427.