ISO 27427:2013
Anaesthetic and respiratory equipment — Nebulizing systems and components
ISO 27427:2013 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.
ISO 27427:2013 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.
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Section sec_1
Section sec_2
Section sec_3
Section sec_3.1
Section sec_3.2
Section sec_3.3
Section sec_3.4
Section sec_3.5
Section sec_3.6
Section sec_3.7
Section sec_3.8
Section sec_3.9
Section sec_3.10
Section sec_3.11
Section sec_3.12
Section sec_3.13
Section sec_3.14
Section sec_3.15
Section sec_3.16
Section sec_3.17
Section sec_3.18
Section sec_3.19
Section sec_3.20
Section sec_4
Section sec_4.1
Section sec_4.1.1
Section sec_4.1.2
Section sec_4.2
Section sec_4.2.1
Section sec_4.2.1.1
Section sec_4.2.1.2
Section sec_4.2.2
Section sec_4.2.3
Section sec_4.3
Section sec_4.4
Section sec_4.5
Section sec_4.6
Section sec_4.7
Section sec_4.7.1
Section sec_4.7.2
Section sec_4.7.3
Section sec_5
Section sec_5.1
Section sec_5.2
Section sec_5.2.1
Section sec_5.2.2
Section sec_5.3
Section sec_5.4
Section sec_5.4.1
Section sec_5.4.2
Section sec_5.4.3
Section sec_5.4.4
Section sec_5.4.5
Section sec_5.4.6
Section sec_5.4.7
Section sec_5.4.8
Section sec_5.4.9
Section sec_5.4.10
Section sec_6
Section sec_6.1
Section sec_6.1.1
Section sec_6.1.2
Section sec_6.1.3
Section sec_6.2
Section sec_6.2.1
Section sec_6.2.2
Section sec_6.2.2.1
Section sec_6.2.2.2
Table tab_a
Figure fig_1
Table tab_b
Figure fig_2
Section sec_6.2.3
Section sec_6.3
Section sec_7
Section sec_7.1
Section sec_7.2
Section sec_7.3
Section sec_8
Section sec_8.1
Section sec_8.2
Annex sec_A
Annex sec_B
Annex sec_C
Annex sec_C.1
Table tab_c
Figure fig_C.1
Annex sec_C.2
Annex sec_C.3
Annex sec_C.4
Annex sec_C.5
Annex sec_D
Annex sec_D.1
Annex sec_D.2
Annex sec_D.3
Annex sec_D.3.1
Table tab_d
Figure fig_D.1
Annex sec_D.3.2
Annex sec_D.3.2.1
Annex sec_D.3.2.2
Annex sec_D.3.2.3
Annex sec_D.3.2.4
Annex sec_D.3.2.5
Annex sec_D.3.2.6
Annex sec_D.3.2.7
Annex sec_D.3.2.8
Annex sec_D.3.2.9
Annex sec_D.3.2.10
Annex sec_D.3.2.11
Annex sec_D.3.2.12
Annex sec_D.4
Annex sec_D.4.1
Table tab_e
Figure fig_D.2
Annex sec_D.4.2
Annex sec_D.4.2.1
Annex sec_D.4.2.2
Annex sec_D.4.2.3
Annex sec_D.4.2.4
Annex sec_D.4.2.5
Annex sec_D.4.2.6
Annex sec_D.4.2.7
Annex sec_D.4.2.8
Annex sec_D.4.2.9
Annex sec_D.4.2.10
Annex sec_D.4.2.11
Annex sec_D.4.2.12
Annex sec_D.5
Annex sec_D.5.1
Annex sec_D.5.2
Table tab_D.1
Table tab_g
Figure fig_D.3
Annex sec_E
Annex sec_E.1
Annex sec_E.2
Annex sec_E.2.1
Annex sec_E.2.2
Annex sec_E.3
Annex sec_F
Annex sec_F.1
Annex sec_F.2
Annex sec_F.2.1
Annex sec_F.2.2
Annex sec_F.2.3
Annex sec_F.3
Annex sec_F.3.1
Annex sec_F.3.2
Annex sec_F.3.3
Annex sec_F.3.4
Annex sec_G
Annex sec_G.1
Table tab_G.1
Annex sec_AA
Table tab_i
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Annex G (informative) Environmental aspects
Annex AA (informative) Conformance to essential principles
Bibliography
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements and requirements for test
4.1 Risk management
4.2 Test methods and alternatives
4.3 Electrical safety
4.4 Mechanical safety
4.5 Pneumatic safety
4.6 Protection against inadvertent adjustments
4.7 Usability
5 Marking
5.1 Symbols
5.2 Marking on the device
5.3 Labelling on the packaging or individual pack
5.4 Instructions for use, inserts, and accompanying documents
6 Construction requirements
6.1 Materials
6.2 Connectors
6.3 Rotary controls
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
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Section sec_1
Section sec_2
Section sec_3
Section sec_3.1
Section sec_3.2
Section sec_3.3
Section sec_3.4
Section sec_3.5
Section sec_3.6
Section sec_3.7
Section sec_3.8
Section sec_3.9
Section sec_3.10
Section sec_3.11
Section sec_3.12
Section sec_3.13
Section sec_3.14
Section sec_3.15
Section sec_3.16
Section sec_3.17
Section sec_3.18
Section sec_3.19
Section sec_3.20
Section sec_4
Section sec_4.1
Section sec_4.1.1
Section sec_4.1.2
Section sec_4.2
Section sec_4.2.1
Section sec_4.2.1.1
Section sec_4.2.1.2
Section sec_4.2.2
Section sec_4.2.3
Section sec_4.3
Section sec_4.4
Section sec_4.5
Section sec_4.6
Section sec_4.7
Section sec_4.7.1
Section sec_4.7.2
Section sec_4.7.3
Section sec_5
Section sec_5.1
Section sec_5.2
Section sec_5.2.1
Section sec_5.2.2
Section sec_5.3
Section sec_5.4
Section sec_5.4.1
Section sec_5.4.2
Section sec_5.4.3
Section sec_5.4.4
Section sec_5.4.5
Section sec_5.4.6
Section sec_5.4.7
Section sec_5.4.8
Section sec_5.4.9
Section sec_5.4.10
Section sec_6
Section sec_6.1
Section sec_6.1.1
Section sec_6.1.2
Section sec_6.1.3
Section sec_6.2
Section sec_6.2.1
Section sec_6.2.2
Section sec_6.2.2.1
Section sec_6.2.2.2
Table tab_a
Figure fig_1
Table tab_b
Figure fig_2
Section sec_6.2.3
Section sec_6.3
Section sec_7
Section sec_7.1
Section sec_7.2
Section sec_7.3
Section sec_8
Section sec_8.1
Section sec_8.2
Annex sec_A
Annex sec_B
Annex sec_C
Annex sec_C.1
Table tab_c
Figure fig_C.1
Annex sec_C.2
Annex sec_C.3
Annex sec_C.4
Annex sec_C.5
Annex sec_D
Annex sec_D.1
Annex sec_D.2
Annex sec_D.3
Annex sec_D.3.1
Table tab_d
Figure fig_D.1
Annex sec_D.3.2
Annex sec_D.3.2.1
Annex sec_D.3.2.2
Annex sec_D.3.2.3
Annex sec_D.3.2.4
Annex sec_D.3.2.5
Annex sec_D.3.2.6
Annex sec_D.3.2.7
Annex sec_D.3.2.8
Annex sec_D.3.2.9
Annex sec_D.3.2.10
Annex sec_D.3.2.11
Annex sec_D.3.2.12
Annex sec_D.4
Annex sec_D.4.1
Table tab_e
Figure fig_D.2
Annex sec_D.4.2
Annex sec_D.4.2.1
Annex sec_D.4.2.2
Annex sec_D.4.2.3
Annex sec_D.4.2.4
Annex sec_D.4.2.5
Annex sec_D.4.2.6
Annex sec_D.4.2.7
Annex sec_D.4.2.8
Annex sec_D.4.2.9
Annex sec_D.4.2.10
Annex sec_D.4.2.11
Annex sec_D.4.2.12
Annex sec_D.5
Annex sec_D.5.1
Annex sec_D.5.2
Table tab_D.1
Table tab_g
Figure fig_D.3
Annex sec_E
Annex sec_E.1
Annex sec_E.2
Annex sec_E.2.1
Annex sec_E.2.2
Annex sec_E.3
Annex sec_F
Annex sec_F.1
Annex sec_F.2
Annex sec_F.2.1
Annex sec_F.2.2
Annex sec_F.2.3
Annex sec_F.3
Annex sec_F.3.1
Annex sec_F.3.2
Annex sec_F.3.3
Annex sec_F.3.4
Annex sec_G
Annex sec_G.1
Table tab_G.1
Annex sec_AA
Table tab_i
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Reference ref_58
Annex G (informative) Environmental aspects
Annex AA (informative) Conformance to essential principles
Bibliography
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements and requirements for test
4.1 Risk management
4.2 Test methods and alternatives
4.3 Electrical safety
4.4 Mechanical safety
4.5 Pneumatic safety
4.6 Protection against inadvertent adjustments
4.7 Usability
5 Marking
5.1 Symbols
5.2 Marking on the device
5.3 Labelling on the packaging or individual pack
5.4 Instructions for use, inserts, and accompanying documents
6 Construction requirements
6.1 Materials
6.2 Connectors
6.3 Rotary controls
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