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BS EN ISO 27427:2023

BS EN ISO 27427:2023

$167.15

Anaesthetic and respiratory equipment. Nebulizing systems and components

Published By Publication Date Number of Pages
BSI 2023 42
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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.

PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
10 3 Terms and definitions
11 4 General requirements and requirements for test
4.1 General
12 4.2 Test methods and alternatives
4.2.1 Test methods for aerosol output, aerosol output rate, and particle sizing
4.2.2 Alternative test methods
4.2.3 Calibration and setup
5 Materials
5.1 General
5.2 Biocompatibility
6 Design Requirements
6.1 General
13 6.2 Inlet and outlet ports
6.2.1 Inlet ports
15 6.2.2 Outlet port
6.3 Flow-direction-sensitive components
6.4 Cleaning and disinfection or sterilization
6.5 Rotary controls
7 Requirement for nebulizing systems and components supplied sterile
8 Packaging
9 Information supplied by the manufacturer
9.1 General
9.2 Marking
9.2.1 General
16 9.2.2 Marking of the nebulizing system:
9.2.3 Marking on the packaging or individual pack
17 9.3 Instructions for use
9.3.1 General information
9.3.2 Performance disclosures
18 9.3.3 Driving gas supply information
19 Annex A (informative) Rationale
23 Annex B (informative) Diameters of respirable fraction particles
24 Annex C (normative) Test methods for aerosol output and aerosol output rate
27 Annex D (normative) Test methods for particle sizing
35 Annex E (informative) Hazard identification for risk assessment
38 Annex F (informative) Classification of general-purpose nebulizers
40 Bibliography

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BS EN ISO 27427:2023
$167.15