• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Entry 01/14/2019 
FR Recognition Number 1-138
Standard(Included in ASCA)
ISO  80601-2-74 First edition 2017-05
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
ISO 80601-2-74:2017 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.
ISO 80601-2-74:2017 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.
ISO 80601-2-74:2017 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.
EXAMPLE 2 Heated humidifier incorporated into a critical care ventilator where ISO 80601-12[12] also applies.
EXAMPLE 3 Heated humidifier incorporated into a homecare ventilator for dependent patients where ISO 80601-2-72[14] also applies.
EXAMPLE 4 Heated humidifier incorporated into sleep apnoea therapy equipment where ISO 80601-2-70[13] also applies.
ISO 80601-2-74:2017 also includes requirements for an active hme (heat and moisture exchanger), me equipment which actively adds heat and moisture to increase the humidity level of the gas delivered from the hme to the patient. This document is not applicable to a passive hme, which returns a portion of the expired moisture and heat of the patient to the respiratory tract during inspiration without adding heat or moisture.
NOTE 4 ISO 9360-1[5] and ISO 9360-2[6] specify the safety and performance requirements for a passive hme.
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 5 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.
ISO 80601-2-74:2017 does not specify the requirements for cold pass-over or cold bubble-through humidification devices, the requirements for which are given in ISO 20789:?.[8]
This document is not applicable to equipment commonly referred to as "room humidifiers" or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators.
ISO 80601-2-74:2017 is not applicable to nebulizers used for the delivery of drugs to patients.
NOTE 6 ISO 27427 specifies the safety and performance requirements for nebulizers.
ISO 80601-2-74:2017 is a particular standard in the IEC 60601-1 and the ISO/IEC 80601 series.
Extent of Recognition
Complete standard
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.
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.
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 Class 2 BZE
§868.5450 Humidifier, Respiratory Gas, (Direct Patient Interface) Class 2 BTT
§868.5454 High Flow/High Velocity Humidified Oxygen Delivery Device Class 2 QAV
§868.5895 Ventilator, Continuous, Facility Use Class 2 CBK
§868.5895 Ventilator, Continuous, Non-Life-Supporting Class 2 MNS
§868.5895 Ventilator, Continuous, Minimal Ventilatory Support, Facility Use Class 2 MNT
§868.5895 Continuous, Ventilator, Home Use Class 2 NOU
§868.5905 Ventilator, Non-Continuous (Respirator) Class 2 BZD
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.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Rebekah Kelly
 Rachana Visaria
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.