| Part B: Supplementary Information Sheet (SIS) |
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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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1-177
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| Standard | (Included in ASCA) |
ISO 80601-2-74 Second edition 2021-07
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment |
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Scope/AbstractThis document applies to the basic safety and essential performance of a humidifier, also hereafter referred to as ME equipment, in combination with its accessories, the combination also hereafter referred to as ME system.
This document is also applicable to those accessories intended by their manufacturer to be connected to a humidifier where the characteristics of those accessories can affect the basic safety or essential performance of the humidifier.
EXAMPLE 1 Heated breathing tubes (heated-wire breathing tubes) or ME equipment intended to control these heated breathing tubes (heated breathing tube controllers).
NOTE 1 Heated breathing tubes and their controllers are ME equipment and are subject to the requirements of IEC 60601‑1.
NOTE 2 ISO 5367 specifies other safety and performance requirements for breathing tubes.
This document includes requirements for the different medical uses of humidification, such as invasive ventilation, non-invasive ventilation, nasal high-flow therapy, and obstructive sleep apnoea therapy, as well as humidification therapy for tracheostomy patients.
NOTE 3 A humidifier can be integrated into other equipment. When this is the case, the requirements of the other equipment also apply to the humidifier.
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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.
This standard is recognized on a scientific basis: Performance specification.
This standard is recognized on a regulatory basis: Pre-market.
NOTE: for devices with a specific intended use population, e.g. neonates, the manufacturer should contact the review team to address sections indicating not to have essential performance prior to testing:
Specifically, Table 201.101- For all other category 2 HUMIDIFIERS for the purposes of this document, category 2 HUMIDIFIERS are considered to not have ESSENTIAL PERFORMANCE, and
Subclause 201.104.1- For a CATEGORY 2 HUMIDIFIER, the ALARM CONDITION is not required. |
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Transition Period
| FDA recognition of ISO 80601-2-74 First edition 2017-05 [Rec# 1-138] will be superseded by recognition of ISO 80601-2-74 Second edition 2021-07 [Rec# 1-177]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-138] until July 4, 2027. After this transition period, declarations of conformity to [Rec# 1-138] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §868.5270 |
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
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Class 2
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BZE
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| §868.5450 |
Humidifier, Respiratory Gas, (Direct Patient Interface)
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Class 2
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BTT
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| §868.5454 |
High Flow/High Velocity Humidified Oxygen Delivery Device
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Class 2
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QAV
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| §868.5895 |
Ventilator, Continuous, Facility Use
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Class 2
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CBK
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| §868.5895 |
Ventilator, Continuous, Non-Life-Supporting
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Class 2
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MNS
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| §868.5895 |
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
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Class 2
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MNT
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| §868.5895 |
Continuous, Ventilator, Home Use
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Class 2
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NOU
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| §868.5905 |
Ventilator, Non-Continuous (Respirator)
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Class 2
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BZD
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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. Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and Food and Drug Administration Staff, issued February 2016.
4. Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," issued September 2020.
5. Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 2005.
6. Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices, Guidance for Industry and Food and Drug Administration Staff. issued July 2016.
7. AAMI COVID-19 Emergency Guidance for the design of ventilator, resuscitator, CPAP/BiPAP systems is available at https://www.aami.org/news-resources/covid-19-updates/covid_cr. Check back frequently for the latest version as these are living documents that evolve with experience.
8. 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.
9. ISO 18562-2 Second edition 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter.
10. 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.
11. ISO 18562-4 Second edition 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate.
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. |
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