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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 062 Date of Entry 05/29/2024 
FR Recognition Number 1-176
Standard
ISO  18562-4 Second Edition 2024-03
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
Scope/Abstract
This document specifies tests for substances leached by liquid water condensing in gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The chemical characterization methods described in this document apply to chemical substances that could leach from the medical device, its parts or accessories into the condensate. This document establishes verifiable acceptance criteria for these tests. The identity and quantity of each chemical released is intended for toxicological risk assessment as described in ISO 18562-1:2024.

This document addresses potential contamination of the gas stream arising from the gas pathways, which deliver breathing gas to the patient.

This document applies over the expected lifetime of the medical device in normal use and takes into account the effects of any intended processing.

This document does not address biological evaluation of the surfaces of gas pathways that have direct contact with the patient. The requirements for direct contact surfaces are found in the ISO 10993 series.

Medical devices, parts or accessories containing gas pathways that are addressed by this document include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, medical respiratory personal protective equipment, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces and any breathing accessories intended to be used with such devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document.

This document does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use.
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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: Biocompatibility.
Transition Period
FDA recognition of ISO 18562-4 First edition 2017-03 [Rec# 1-137] will be superseded by recognition of ISO 18562-4 Second Edition 2024-03 [Rec# 1-176]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-137] until July 05, 2026. After this transition period, declarations of conformity to [Rec# 1-137] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§868.1400 Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Class 2 CCK
§868.1840 Spirometer, Diagnostic Class 2 BZG
§868.1840 Impedance Measuring Device Utilizing Oscillation Techniques Class 2 PNV
§868.2885 Transducer, Gas Flow Class 1 BXP
§868.5160 Gas-Machine, Anesthesia Class 2 BSZ
§868.5260 Filter, Bacterial, Breathing-Circuit Class 2 CAH
§868.5270 Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer Class 2 BZE
§868.5330 Mixer, Breathing Gases, Anesthesia Inhalation Class 2 BZR
§868.5340 Cannula, Nasal, Oxygen Class 1 CAT
§868.5440 Generator, Oxygen, Portable Class 2 CAW
§868.5450 Humidifier, Respiratory Gas, (Direct Patient Interface) Class 2 BTT
§868.5454 High Flow/High Velocity Humidified Oxygen Delivery Device Class 2 QAV
§868.5580 Mask, Oxygen Class 1 BYG
§868.5620 Mouthpiece, Breathing Class 1 BYP
§868.5630 Nebulizer (Direct Patient Interface) Class 2 CAF
§868.5690 Spirometer, Therapeutic (Incentive) Class 2 BWF
§868.5730 Tube, Tracheal (W/Wo Connector) Class 2 BTR
§868.5800 Tube Tracheostomy And Tube Cuff Class 2 JOH
§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
§868.5905 Conserver, Oxygen Class 2 NFB
§868.5905 Device, Positive Pressure Breathing, Intermittent Class 2 NHJ
§868.5915 Ventilator, Emergency, Manual (Resuscitator) Class 2 BTM
§868.5925 Ventilator, Emergency, Powered (Resuscitator) Class 2 BTL
§868.5975 Set, Tubing And Support, Ventilator (W Harness) Class 1 BZO
§868.6250 Compressor, Air, Portable Class 2 BTI
§880.5400 Incubator, Neonatal Class 2 FMZ
Relevant FDA Guidance and/or Supportive Publications*
Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", Guidance for Industry and Food and Drug Administration Staff, issued September 2020.

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
 Rakhi Dalal
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  301-796-6418
  Rakhi.Dalal@fda.hhs.gov
 John Bender
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  240-402-1728
  John.Bender@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Anesthesiology
*These are provided as examples and others may be applicable.
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