Table of Contents

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements and requirements for test
5 Marking
6 Construction requirements
7 Cleaning, sterilization and disinfection
8 Biocompatibility
Annex A (informative) - Rationale
Annex B (normative) - Diameters of respirable
        fraction particles
Annex C (normative) - Test methods for aerosol
        output and aerosol output rate
Annex D (normative) - Test methods for particle
        sizing
Annex E (informative) - Hazard identification for
        risk assessment
Annex F (informative) - Classification of general
        purpose nebulizers
Annex G (informative) - Environmental aspects
Annex AA (informative) - Conformance to essential
         principles
Bibliography

Abstract

This International Standard 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.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
ProductNote	THIS STANDARD ALSO REFERS TO ISO/IEEE 11073 (all parts), ISO 11607 (all parts),ISO 11737 (all parts),ISO 13408 (all parts),ISO 14155 (all parts),ISO 14644 (all parts),ISO 22442 (all parts),IEC 61010 (all parts),ISO 10993-20,
Pages
ISBN
Committee	TC 121
Supersedes	ISO/DIS 27427 : 60.00 (2013) ISO 27427 : 2010