| 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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1-174
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| Standard | |
ISO 18562-2 Second edition 2024-03
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter |
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Scope/AbstractThis document specifies tests for the emissions of particulate matter 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 particles from 0,25 µm diameter to 10 µm diameter that are emitted by the medical device, its parts or accessories into the respirable gas stream. This document establishes acceptance criteria for these tests.
This document does not address nanoparticles. Insufficient data exist to establish exposure limits for particles less than 0,25 µm diameter.
This document does not address particles larger than 10 µm diameter. These particles are deposited in the nasal cavity. Additional information can be needed for medical devices or accessories that bypass the nose. This is outside the scope of this document but can be required by some authorities having jurisdiction.
This document therefore adopts the same approach as the US Environmental Protection Agency (EPA) in setting limits based solely on particle size and not their chemistry.
This document addresses potential contamination of the gas stream arising from the gas pathways, 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 particles that are deliberately released by a nebulizer (i.e. the therapeutic agent).
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.
... |
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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. |
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Transition Period
| FDA recognition of ISO 18562-2 First edition 2017-03 [Rec# 1-135] will be superseded by recognition of ISO 18562-2 Second edition 2024-03 [Rec# 1-174]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-135] until July 05, 2026. After this transition period, declarations of conformity to [Rec# 1-135] 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
|
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
|
| §868.5630 |
Holding Chambers, Direct Patient Interface
|
Class 2
|
NVP
|
| §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
|
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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. |
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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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