Part B: Supplementary Information Sheet (SIS) |
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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1-179
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Standard | |
ISO 26782 First edition 2009-07 Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans [Including: Technical Corrigendum 1 (2009)] |
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Scope/AbstractISO 26782:2009 specifies requirements for spirometers intended for the assessment of pulmonary function in humans weighing more than 10 kg.
ISO 26782:2009 applies to spirometers that measure timed forced expired volumes, either as part of an integrated lung function device or as a stand-alone device, irrespective of the measuring method employed. |
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Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized: |
Clause 7.1 Accuracy
Clause 7.7 Linearity
Clause 7.8 Repeatability
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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.
This standard is recognized in part because: Clauses 7.1, 7.7, and 7.8 of ISO 26782 are in conflict with an existing published literature, see Key Updates and Equipment Section of American Thoracic Society and European Respiratory Society Standard for Spirometry (reference #1 listed below). |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§868.1840 |
Spirometer, Diagnostic
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Class 2
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BZG
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§868.1840 |
Impedance Measuring Device Utilizing Oscillation Techniques
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Class 2
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PNV
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§868.1880 |
Calculator, Pulmonary Function Data
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Class 2
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BZC
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§868.1890 |
Calculator, Predicted Values, Pulmonary Function
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Class 2
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BTY
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Relevant FDA Guidance and/or Supportive Publications*
1. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. American Journal of Respiratory and Critical Care Medicine. Volume 200, Issue 8.
2. Electromagnetic Compatibility (EMC) of Medical Devices: Guidance for Industry and FDA Staff, issued June 2022.
3. Content of Premarket Submissions for Device Software Functions: Guidance for Industry and FDA Staff, issued June 2023.
4. Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions: Guidance for Industry and FDA Staff, issued September 2023.
5. Policy for Device Software Functions and Mobile Medical Applications: Guidance for Industry and FDA Staff, issued September 2022.
6. Content of Premarket Submissions for Device Software Functions: Guidance for Industry and FDA Staff, issued June 2023.
7. Use of International Standard ISO 10993-1,"Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process": Guidance for Industry and FDA Staff, issued September 2023.
8. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, issued March 2015.
9. Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff, issued April 2016.
10. 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. |