Standards Development

Scope

Below is the current scope of the published ISO 27427: 2023

This document specifies requirements for the safety and performance testing of general-purpose nebulizing systems intended for continuous or breath-actuated delivery of liquids, in aerosol form, to humans through the respiratory system.

This document includes gas-powered nebulizers (which can be powered by, e.g., compressors, pipeline systems, cylinders, etc.) and electrically powered nebulizers [e.g. spinning disc, ultrasonic, vibrating mesh (active and passive), and capillary devices] or manually powered nebulizers.

This document does not specify the electrical requirements of electrically powered nebulizers. This document does not specify the minimum performance of nebulizing systems.

This document does not apply to:

a) devices intended for nasal deposition;

b) devices intended solely to provide humidification or hydration by providing water in aerosol form.

NOTE 1 ISO 80601-2-74 and ISO 20789 cover these devices.

c) drug-specific nebulizers or their components (e.g. metered dose inhalers, metered liquid inhalers, dry powder inhalers).

The scope of this standard will be merged with the scope of ISO/CD 80601-2-94 ED1(refer to 62D/2186/CD).

Purpose

Inhalational therapy nebulizing systems are widely used to deliver drugs and vaccines in an aerosol form to humans through the respiratory system. Nebulizers are also used for diagnostic purposes using radioisotopes for lung challenge tests. These drugs can be in the form of a solution, suspension or emulsion. Aerosol inhalation is the preferred route of administration for some drugs. Some drugs are intended for treatment of systemic diseases and other drugs are intended to treat respiratory diseases. To achieve the intended treatment, aerosol particles have to be deposited in specific parts of the respiratory tract. Different size particles tend to deposit in different parts of the respiratory system; therefore, the performance profile and the intended use of the nebulizer are defined by the manufacturer and specified in the accompanying documentation.

The details of nebulizers (e.g., the test methods for aerosol output) aerosol output rate, and particle sizing are given in ISO 27427, Anaesthetic and respiratory equipment — Nebulizing systems and components.