ISO/TC 121/SC 2/WG 15 - Nebulizing systems and components
Systèmes de nébulisation et leurs composants
General Information
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). NOTE 2 ISO 20072 covers these devices. NOTE 3 See Annex A for rationale.
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Frequently Asked Questions
ISO/TC 121/SC 2/WG 15 is a Subcommittee within the International Organization for Standardization (ISO). It is named "Nebulizing systems and components". This committee has published 1 standards.
ISO/TC 121/SC 2/WG 15 develops ISO standards in the area of Information technology. Currently, there are 1 published standards from this subcommittee.
The International Organization for Standardization (ISO) is an independent, non-governmental international organization that develops and publishes international standards. Founded in 1947 and headquartered in Geneva, Switzerland, ISO brings together experts from 170+ member countries to share knowledge and develop voluntary, consensus-based standards that support innovation and provide solutions to global challenges.
A Subcommittee (SC) in ISO operates under a Technical Committee and focuses on a specific subset of the TC's scope. Subcommittees develop standards and technical specifications in their specialized area, reporting to their parent Technical Committee. They may also have working groups for detailed technical work.