| 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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1-175
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| Standard | |
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 |
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Scope/AbstractThis document specifies tests for the emissions of volatile organic substances from the 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 emissions of volatile organic substances that are added to the respirable gas stream by the materials of the gas pathway. This document establishes acceptance criteria for these tests.
NOTE Gaseous emission of volatile organic substances includes emissions of volatile organic compounds, semi-volatile organic compounds and very volatile organic compounds.
This document addresses potential contamination of the gas stream arising from the gas pathways of medical devices or accessories, which is then conducted 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 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, 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
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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: Biocompatibility.
Note of Editorial Error:
Note 4 of Clause 5.2 g) 2) states that "[i]f there is an indication that there are VVOCs in the analysis according to ISO 16000-6, then further testing using ISO 16000-6:2021, Annex D, can be appropriate." However, Annex D of ISO 16000-6: 2021 no longer discusses analytical approaches to determine VVOC levels. The determination of VVOCs is discussed throughout ISO 16000-6: 2021. |
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Transition Period
| FDA recognition of ISO 18562-2 First edition 2017-03 [Rec# 1-135], and ISO 18562-3 First edition 2017-03 [Rec# 1-136] will be superseded by recognition of ISO 18562-3 Second Edition 2024-03 [Rec# 1-175]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-135] and [Rec# 1-136] until July 05, 2026. After this transition period, declarations of conformity to [Rec# 1-135] and [Rec# 1-136] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §868.1400 |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
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Class 2
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CCK
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| §868.1840 |
Spirometer, Diagnostic
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Class 2
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BZG
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| §868.1840 |
Impedance Measuring Device Utilizing Oscillation Techniques
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Class 2
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PNV
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| §868.2885 |
Transducer, Gas Flow
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Class 1
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BXP
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| §868.5160 |
Gas-Machine, Anesthesia
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Class 2
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BSZ
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| §868.5260 |
Filter, Bacterial, Breathing-Circuit
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Class 2
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CAH
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| §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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| §868.5330 |
Mixer, Breathing Gases, Anesthesia Inhalation
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Class 2
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BZR
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| §868.5340 |
Cannula, Nasal, Oxygen
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Class 1
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CAT
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| §868.5440 |
Generator, Oxygen, Portable
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Class 2
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CAW
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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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| §868.5580 |
Mask, Oxygen
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Class 1
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BYG
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| §868.5620 |
Mouthpiece, Breathing
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Class 1
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BYP
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| §868.5630 |
Nebulizer (Direct Patient Interface)
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Class 2
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CAF
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| §868.5690 |
Spirometer, Therapeutic (Incentive)
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Class 2
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BWF
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| §868.5730 |
Tube, Tracheal (W/Wo Connector)
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Class 2
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BTR
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| §868.5800 |
Tube Tracheostomy And Tube Cuff
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Class 2
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JOH
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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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| §868.5905 |
Conserver, Oxygen
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Class 2
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NFB
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| §868.5905 |
Device, Positive Pressure Breathing, Intermittent
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Class 2
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NHJ
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| §868.5915 |
Ventilator, Emergency, Manual (Resuscitator)
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Class 2
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BTM
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| §868.5975 |
Set, Tubing And Support, Ventilator (W Harness)
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Class 1
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BZO
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| §868.6250 |
Compressor, Air, Portable
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Class 2
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BTI
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| §880.5400 |
Incubator, Neonatal
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Class 2
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FMZ
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Relevant FDA Guidance and/or Supportive Publications*
1. 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.
2. ISO 16000-6 Third edition 2021-08 Indoor air - Part 6: Determination of organic compounds (VVOC, VOC, SVOC) in indoor and test chamber air by active sampling on sorbent tubes, thermal desorption and gas chromatography using MS or MS FID.
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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