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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 049 Date of Entry 06/07/2018 
FR Recognition Number 1-137
ISO  18562-4 First edition 2017-03
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
ISO 18562-4:2017 specifies tests for substances leached by liquid water condensing into 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 tests of this document are intended to quantify hazardous water-soluble substances that are leached from the medical device, its parts or accessories by condensate and then conveyed by that liquid to the patient. This document establishes acceptance criteria for these tests.
ISO 18562-4:2017 addresses potential contamination of the gas stream arising from the gas pathways, which is then conducted to the patient.
ISO 18562-4:2017 applies over the expected service life of the medical device in normal use and takes into account the effects of any intended processing or reprocessing.
ISO 18562-4:2017 does not address biological evaluation of the surfaces of gas pathways that are in 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, 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.
ISO 18562-4:2017 does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use.
EXAMPLE Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder, or room air taken into the medical device is not addressed by ISO 18562 series.
ISO 18562-4:2017 does not address contact with drugs or anaesthetic agents. If a medical device is intended to be used with anaesthetic agents or drugs, then additional testing can be required.
This document is intended to be read in conjunction with ISO 18562‑1.
NOTE This document has been prepared to address the relevant essential principles of safety and performance as indicated in Annex B.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Subclause 5.2 Test Method, b) "Convert the concentration of each metal ion to a total dose/day by considering the total amount of liquid condensate that reaches the patient in a day as 1 ml."

Subclause 5.2 Test Method, c) "Convert the concentration of each substance to a total dose per patient per day by considering the total amount of condensate that reaches the patient per day as 1 ml. Confirm that the dose of each identified substance delivered to the patient in 1 ml of condensate or extract is less than the tolerable intake or threshold of toxicological concern derived from the method of ISO 18562-1:2017, Clause 7."

Subclause 5.2 Test Method, e) "Perform a sensitization test according to ISO 10993-10 on the condensate or extract. Select a method suitable for liquids."

Annex A.2 Rationale for particulare clauses and subclauses d) and e)
Rationale for Recognition
This standard is recognized on a scientific basis: Biocompatibility

This standard is recognized in part because:
Subclause 5.2 and Annex A contain test method and/or specification that is not scientifically acceptable.
Subclause 5.2 and Annex A are in conflict with existing published final guidance.
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
§868.5160 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
§868.5580 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 Continuous, Ventilator, Home Use Class 2 NOU
§868.5895 Ventilator, Continuous, Minimal Ventilatory Support, Facility Use Class 2 MNT
§868.5895 Ventilator, Continuous, Non-Life-Supporting Class 2 MNS
§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
 John Bender
 Rakhi Dalal
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.