| Part B: Supplementary Information Sheet (SIS) |
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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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1-188
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| Standard | (Included in ASCA) |
ISO 80601-2-84 Second edition 2023-11
Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment |
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Scope/AbstractThis document applies to the basic safety and essential performance of an EMS ventilator in combination with its accessories, hereafter also referred to as ME equipment:
- intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients;
- intended to be operated by a healthcare professional operator;
- intended for use in the EMS environment; and
- intended for invasive or non-invasive ventilation.
NOTE 2 An EMS ventilator can also be used for transport within a professional healthcare facility.
An EMS ventilator is not considered to use a physiologic closed loop-control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system, or to an EMS ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the EMS ventilator.
NOTE 3 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 4 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
This document does not specify the requirements for the following:
NOTE 5 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient.
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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 80601-2-84 First edition 2020-07 [Rec# 1-160] will be superseded by recognition of ISO 80601-2-84 Second edition 2023-11 [Rec# 1-188]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-160] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 1-160] 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, Facility Use
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Class 2
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CBK
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| §868.5925 |
Ventilator, Emergency, Powered (Resuscitator)
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Class 2
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BTL
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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 4135 Fourth edition 2022-01 Anaesthetic and respiratory equipment - Vocabulary.
7. ISO 19223 First edition 2019-07 Lung ventilators and related equipment - Vocabulary and semantics.
8. Guidance on Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, Final Guidance for Industry and FDA Staff, issued September 2023.
9. IMDRF/GRRP WG/N47 Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices, issued April 2024.
10. IMDRF/GRRP WG/N52 Principles of Labelling for Medical Devices and IVD Medical Devices, issued April 2024.
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. |
