Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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063
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Date of Entry 12/23/2024
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FR Recognition Number
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1-186
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Standard | (Included in ASCA) |
ISO 80601-2-80 Second edition 2024-08 Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency |
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Scope/AbstractNOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.
This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.302, for ventilatory insufficiency, as defined in 201.3.302, hereafter also referred to as ME equipment, in combination with its accessories:
- intended for use in the home healthcare environment;
NOTE 2 In the home healthcare environment, the supply mains driving the ventilatory support equipment is often not reliable.
NOTE 3 Such ventilatory support equipment can also be used in professional health care facilities.
- intended for use by a lay operator;
- intended for use with patients who have ventilatory insufficiency or failure, the most fragile of which would likely experience injury with the loss of this artificial ventilation;
- intended for transit-operable use; and
- not intended for patients who are dependent on artificial ventilation for their immediate life support. ... |
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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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Transition Period
FDA recognition of ISO 80601-2-80 First edition 2018-07 [Rec# 1-144] will be superseded by recognition of ISO 80601-2-80 Second edition 2024-08 [Rec# 1-186]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-144] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 1-144] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§868.5895 |
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
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Class 2
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MNT
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Relevant FDA Guidance and/or Supportive Publications*
1. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.
2. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, issued March 2015.
3. Guidance for Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff, issued June 2023.
4. Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff, issued April 2016.
5. Guidance on Medical Device Patient Labeling: Final Guidance for Industry and FDA Staff, issued April 2001.
6. 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.
7. ISO 18562-2 Second edition 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter.
8. 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.
9. ISO 18562-4 Second edition 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate.
10. Guidance on Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, Final Guidance for Industry and FDA Staff, issued September 2023.
11. ISO 14971 Third Edition 2019-12 Medical devices - Application of risk management to medical devices.
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. |