| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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058
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Date of Entry 05/30/2022
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FR Recognition Number
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1-152
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| Standard | (Included in ASCA) |
ISO 80601-2-87 First edition 2021-04
Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators |
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Scope/AbstractThis document applies to the basic safety and essential performance of a high-frequency ventilator (HFV) in combination with its accessories, hereafter referred to as ME equipment:
- intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility;
NOTE 1 For the purposes of this document, such an environment is referred to as a critical care environment. High-frequency ventilators for this environment are considered life-sustaining.
NOTE 2 For the purposes of this document, such a high-frequency ventilator can provide transport within a professional healthcare facility (i.e., be a transit-operable ventilator).
NOTE 3 A high-frequency ventilator intended for use in transport within a professional healthcare facility is not considered as a ventilator intended for the emergency medical services environment.
- intended to be operated by a healthcare professional operator;
- intended for those patients who need differing levels of support from artificial ventilation including ventilator-dependent patients; and
- capable of providing more than 150 inflations/min.
There are three principal designations of HFV:
- high-frequency percussive ventilation [HFPV, with a typical HFV frequency of (60 to 1 000) HFV inflations/min];
- high-frequency jet ventilation [HFJV, with a typical HFV frequency of (100 to 1 500) HFV inflations/min]; and
- high-frequency oscillatory ventilation [HFOV, with a typical HFV frequency of (180 to 1200) HFV inflations/min and typically having an active expiratory phase].
Additionally, HFV designations can be combined together or with ventilation at rates less than 150 inflations/min.
* A high-frequency ventilator is not considered a physiologic closed loop-control system unless it uses a physiological patient variable to adjust the ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to an HFV breathing system, or to a high-frequency ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the high-frequency ventilator.
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 7.2.13 and 8.4.1 of IEC 60601-1:2005.
NOTE 4 Additional information can be found in 4.2 of IEC 60601-1:2005+AMD1:2012.
This document is not applicable to ME equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility. |
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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 |
| N/A |
Ventilator, High Frequency |
Class 3
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LSZ
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Relevant FDA Guidance and/or Supportive Publications*
1. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.
2. Guidance for Industry and Food and Drug Administration Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, 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. Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to Medical Devices, Issued April 2016.
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 Contact
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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. |
