| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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052
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Date of Entry 07/15/2019
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FR Recognition Number
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1-144
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| Standard | (Included in ASCA) |
ISO 80601-2-80 First edition 2018-07
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/AbstractThis document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.205, for ventilatory insufficiency, as defined in 201.3.204, hereafter also referred to as me equipment, in combination with its accessories:
- intended for use in the home healthcare environment;
- 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;
- not intended for patients who are dependent on artificial ventilation for their immediate life support.
EXAMPLE 1 Patients with moderate to severe chronic obstructive pulmonary disease (COPD), moderate amyotrophic lateral sclerosis (ALS), severe bronchopulmonary dysplasia or muscular dystrophy.
NOTE 1 In the home healthcare environment, the supply mains is often not reliable.
NOTE 2 Such ventilatory support equipment can also be used in non-critical care applications of professional health care facilities.
This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system of ventilatory support equipment for ventilatory insufficiency, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory insufficiency.
EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system.
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, 7.2.13 and 8.4.1.
NOTE 3 Additional information can be found in IEC 60601 1:2005+AMD1:2012, 4.2.
This document does not specify the requirements for:
- ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601 2 12;
- ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601 2 13[5];
- ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601 2 84[6][1], the future replacement for ISO 10651 3[7];
- ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601 2 72;
- ventilatory support equipment or accessories intended for ventilatory impairment, which are given in ISO 80601 2 79[1];
- sleep apnoea therapy me equipment, which are given in ISO 80601 2 70[8];
- continuous positive airway pressure (CPAP) me equipment;
- high-frequency jet ventilators (HFJVs);
- high-frequency oscillatory ventilators (HFOVs)[9];
- oxygen therapy constant flow me equipment;
- cuirass or "iron-lung" ventilation equipment. |
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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 |
| §868.5895 |
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.
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. |
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