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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Recognition 01/14/2019 
FR Recognition Number 1-138
Standard
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
Scope/Abstract
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[10] 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.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§868.5905 Ventilator, Non-Continuous (Respirator) Class 2 BZD
§868.5895 Continuous, Ventilator, Home Use Class 2 NOU
§868.5895 Ventilator, Continuous, Facility Use Class 2 CBK
§868.5895 Ventilator, Continuous, Minimal Ventilatory Support, Facility Use Class 2 MNT
§868.5895 Ventilator, Continuous, Non-Life-Supporting Class 2 MNS
§868.5450 Humidifier, Respiratory Gas, (Direct Patient Interface) Class 2 BTT
§868.5270 Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer Class 2 BZE
Relevant FDA Guidance and/or Supportive Publications
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, Guidance for Industry and Food and Drug Administration Staff, Issued March 2015.

Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and Food and Drug Administration Staff, Issued February 2016.

Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," Issued June 2016.

Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Issued May 2005.

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.
FDA Technical Contacts
 Derya Coursey
  FDA/OMPT/CDRH/ODE/DAGID/RPDB/
  240-402-6130
  Derya.Coursey@fda.hhs.gov
 Rachana Visaria
  FDA/OMPT/CDRH/ODE/DAGID/RPDB/
  240-402-5628
  Rachana.Visaria@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Anesthesiology
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