| 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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1-173
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| Standard | |
ISO 18562-1 Second edition 2024-03
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process |
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Scope/AbstractThis document specifies:
- the general principles governing the biological evaluation within a risk management process of 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 general categorization of gas pathways based on the nature and duration of their contact with the gas stream;
- the evaluation of existing relevant data from all sources;
- the identification of gaps in the available data set on the basis of a risk analysis;
- the identification of additional data sets necessary to analyse the biological safety of the gas pathway;
- the assessment of the biological safety of the gas pathway.
This document covers general principles regarding biocompatibility assessment of medical device materials, which make up the gas pathway, in normal use and normal condition. This document does not cover biological hazards arising from mechanical damage.
The other parts of ISO 18562 cover specific tests that address potentially hazardous substances that are added to the respirable gas stream and establish acceptance criteria for these substances.
This document addresses potential contamination of the gas stream arising from the gas pathways within the medical device, which might then be conducted to the patient.
This document applies over the expected lifetime of the medical device when operated according to the instructions for use. This includes degradation arising from exposure to environmental conditions as well as cleaning, disinfection and sterilisation (i.e. processing). It also includes user action or inaction (omission) that leads to an unintended or unexpected outcome (result) (i.e. use error). It does not include conscious/intentional action or inaction that violates the instructions for use and is beyond reasonable risk control by the manufacturer (i.e. abnormal use).
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
Clause 7.2 b) 1) Parenteral toxicological information may be used in the absence of inhalational toxicological information without modification.
Clause 7.3 b) 1) Parenteral toxicological information may be used in the absence of inhalational toxicological information without modification. |
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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.
Other reason for recognition: Biocompatibility
This standard is recognized in part because:
Clause 7.2 b) 1) and Clause 7.3 b) 1) are in conflict with another recognized standard, see C.2.2.4.1 Route-to-route extrapolation of ISO 10993-17: 2023 listed below. |
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Transition Period
| FDA recognition of ISO 18562-1 First edition 2017-03 [Rec# 1-134] will be superseded by recognition of ISO 18562-1 Second edition 2024-03 [Rec# 1-173]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-134] until July 05, 2026. After this transition period, declarations of conformity to [Rec# 1-134] 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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| §868.5450 |
Humidifier, Respiratory Gas, (Direct Patient Interface)
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Class 2
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BTT
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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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| §868.5630 |
Holding Chambers, Direct Patient Interface
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Class 2
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NVP
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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
|
| §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
|
| §868.5915 |
Ventilator, Emergency, Manual (Resuscitator)
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Class 2
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BTM
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| §868.5925 |
Ventilator, Emergency, Powered (Resuscitator)
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Class 2
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BTL
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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
|
| §880.5400 |
Incubator, Neonatal
|
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 10993-17 Second edition 2023-09 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents.
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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