| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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062
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Date of Entry 05/29/2024
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FR Recognition Number
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1-178
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| Standard | |
ISO 23747 Second edition 2015-08
Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans |
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Scope/AbstractISO 23747:2015 specifies requirements for a peak expiratory flow meter (pefm) intended for the assessment of pulmonary function in spontaneously breathing humans.
ISO 23747:2015 covers all medical devices that measure peak expiratory flowrate in spontaneously breathing humans either as part of an integrated lung function medical device or as a stand-alone medical device.
Planning and design of products applying to this International Standard are to consider the environmental impact from the product during its life cycle. Environmental aspects are addressed in Annex E.
NOTE Additional aspects of environmental impact are addressed in ISO 14971. |
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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 |
| §868.1840 |
Spirometer, Diagnostic
|
Class 2
|
BZG
|
| §868.1840 |
Impedance Measuring Device Utilizing Oscillation Techniques
|
Class 2
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PNV
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| §868.1860 |
Meter, Peak Flow, Spirometry
|
Class 2
|
BZH
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| §868.1880 |
Calculator, Pulmonary Function Data
|
Class 2
|
BZC
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| §868.1890 |
Calculator, Predicted Values, Pulmonary Function
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Class 2
|
BTY
|
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Relevant FDA Guidance and/or Supportive Publications*
1. Electromagnetic Compatibility (EMC) of Medical Devices: Guidance for Industry and FDA Staff, issued June 2022.
2. Content of Premarket Submissions for Device Software Functions: Guidance for Industry and FDA Staff, issued June 2023.
3. Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions: Guidance for Industry and FDA Staff, issued September 2023.
4. Policy for Device Software Functions and Mobile Medical Applications: Guidance for Industry and FDA Staff, issued September 2022.
5. Content of Premarket Submissions for Device Software Functions: Guidance for Industry and FDA Staff, issued June 2023.
6. Use of International Standard ISO 10993-1, "Biological Evaluation of medial devices - Part 1: Evaluation and testing within a risk management process": Guidance for Industry and FDA Staff, issued September 2023.
7. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, issued March 2015.
8. Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff, issued February 2016.
9. Guidance on Medical Device Patient Labeling: Final Guidance for Industry and FDA Staff, issued April 2001.
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. |
