| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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064
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Date of Entry 05/26/2025
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FR Recognition Number
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1-194
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| Standard | |
ISO 27427 Fourth edition 2023-07
Anaesthetic and respiratory equipment - Nebulizing systems and components |
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Scope/AbstractThis 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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| Extent of Recognition
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Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §868.5630 |
Nebulizer (Direct Patient Interface)
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Class 2
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CAF
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Relevant FDA Guidance and/or Supportive Publications*
1. Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators, issued October 1993.
2. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.
3. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, issued March 2015.
4. Guidance for Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff, issued June 2023.
5. Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff, issued September 2023.
6. Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff, issued April 2016.
7. Guidance on Medical Device Patient Labeling: Final Guidance for Industry and FDA Staff, issued April 2001.
8. ISO 18562-1 Second edition 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process.
9. ISO 18562-2 Second edition 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter.
10. ISO 18562-3 Second edition 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds.
11. ISO 18562-4 Second edition 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate.
12. ISO 4135 Fourth edition 2022-01 Anaesthetic and respiratory equipment - Vocabulary.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
