BS EN ISO 27427:2019
$198.66
Anaesthetic and respiratory equipment. Nebulizing systems and components
| Published By | Publication Date | Number of Pages |
| BSI | 2019 | 56 |
*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.
This International Standard 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 International Standard does not specify the minimum performance of nebulizing systems .
*This International Standard does not apply to devices intended for nasal deposition.
This International Standard does not apply to devices intended solely to provide humidification or hydration by providing water in aerosol form.
NOTE ISO 8185 covers this.[ 3 ]
*This International Standard does not apply to drug-specific nebulizers or their components (e.g., metered dose inhalers, metered liquid inhalers, dry powder inhalers).
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | National foreword |
| 4 | European foreword Endorsement notice |
| 6 | Foreword |
| 7 | Introduction |
| 8 | Section sec_1 Section sec_2 1 Scope 2 Normative references |
| 9 | Section sec_3 3 Terms and definitions |
| 10 | 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 |
| 11 | 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 4 General requirements and requirements for test 4.1 Risk management |
| 12 | 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 4.2 Test methods and alternatives 4.3 Electrical safety 4.4 Mechanical safety |
| 13 | 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 4.5 Pneumatic safety 4.6 Protection against inadvertent adjustments 4.7 Usability 5 Marking 5.1 Symbols 5.2 Marking on the device |
| 14 | Section sec_5.2.2 Section sec_5.3 5.3 Labelling on the packaging or individual pack |
| 15 | Section sec_5.4 Section sec_5.4.1 Section sec_5.4.2 5.4 Instructions for use, inserts, and accompanying documents |
| 16 | Section sec_5.4.3 |
| 17 | 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 |
| 18 | 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 6 Construction requirements 6.1 Materials 6.2 Connectors |
| 19 | Section sec_6.2.2.2 Table tab_a Figure fig_1 |
| 20 | Table tab_b Figure fig_2 Section sec_6.2.3 Section sec_6.3 6.3 Rotary controls |
| 21 | 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 7 Cleaning, sterilization, and disinfection 8 Biocompatibility |
| 22 | Annex sec_A Annex A (informative) Rationale |
| 26 | Annex sec_B Annex B (normative) Diameters of respirable fraction particles |
| 27 | Annex sec_C Annex sec_C.1 Table tab_c Figure fig_C.1 Annex C (normative) Test methods for aerosol output and aerosol output rate |
| 28 | Annex sec_C.2 Annex sec_C.3 Annex sec_C.4 |
| 29 | Annex sec_C.5 |
| 30 | Annex sec_D Annex sec_D.1 Annex sec_D.2 Annex sec_D.3 Annex sec_D.3.1 Annex D (normative) Test methods for particle sizing |
| 31 | Table tab_d Figure fig_D.1 Annex sec_D.3.2 Annex sec_D.3.2.1 Annex sec_D.3.2.2 |
| 32 | 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 |
| 34 | 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 |
| 35 | 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 |
| 37 | Annex sec_D.5.2 Table tab_D.1 |
| 38 | Table tab_g Figure fig_D.3 |
| 39 | Annex sec_E Annex sec_E.1 Annex E (informative) Hazard identification for risk assessment |
| 41 | Annex sec_E.2 Annex sec_E.2.1 Annex sec_E.2.2 |
| 43 | Annex sec_E.3 |
| 45 | 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 F (informative) Classification of general purpose nebulizers |
| 46 | Annex sec_F.3.2 Annex sec_F.3.3 Annex sec_F.3.4 |
| 47 | Annex sec_G Annex sec_G.1 Table tab_G.1 Annex G (informative) Environmental aspects Environmental aspects |
| 49 | Annex sec_AA Table tab_i Annex AA (informative) Conformance to essential principles Conformance to essential principles |
| 53 | Reference ref_1 Reference ref_2 Reference ref_3 Reference ref_4 Reference ref_5 Reference ref_6 Reference ref_7 Reference ref_8 Reference ref_9 Reference ref_10 Reference ref_11 Reference ref_12 Reference ref_13 Reference ref_14 Reference ref_15 Reference ref_16 Reference ref_17 Reference ref_18 Reference ref_19 Reference ref_20 Reference ref_21 Reference ref_22 Reference ref_23 Reference ref_24 Bibliography Bibliography |
| 54 | Reference ref_25 Reference ref_26 Reference ref_27 Reference ref_28 Reference ref_29 Reference ref_30 Reference ref_31 Reference ref_32 Reference ref_33 Reference ref_34 Reference ref_35 Reference ref_36 Reference ref_37 Reference ref_38 Reference ref_39 Reference ref_40 Reference ref_41 Reference ref_42 Reference ref_43 Reference ref_44 Reference ref_45 Reference ref_46 Reference ref_47 |
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