| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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040
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Date of Entry 08/14/2015
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FR Recognition Number
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1-103
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| Standard | |
ISO 5367 Fifth edition 2014-10-15
Anaesthetic and respiratory equipment - Breathing sets and connectors |
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Scope/AbstractISO 5367:2014 specifies basic requirements for breathing sets and breathing tubes intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers or nebulizers. It applies to breathing sets and breathing tubes and patient end adaptors supplied already assembled and to those supplied as components and assembled in accordance with the manufacturer's instructions.
ISO 5367:2014 is applicable to breathing sets which include special components (e.g. water traps) between the patient end and machine end which are supplied already assembled.
Provision is made for coaxial and related bifurcated, double-lumen, or multiple-lumen breathing sets and breathing tubes suitable for use with patient end adaptors. |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
Clause 8.1 General
Clause 8.4.2 The manufacturer shall, when requested, provide information on the recommended maximum working temperature of the breathing set or breathing tube when attached to a heated humidifier. |
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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. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §868.5160 |
Gas machine for anesthesia or analgesia.
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| §868.5240 |
Anesthesia breathing circuit.
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| §868.5250 |
Breathing circuit circulator.
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| §868.5450 |
Respiratory gas humidifier.
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| §868.5730 |
Tracheal tube.
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| §868.5800 |
Tracheostomy tube and tube cuff.
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| §868.5895 |
Continuous ventilator.
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| §868.5905 |
Noncontinuous ventilator (IPPB).
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Relevant FDA Guidance and/or Supportive Publications*
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff, issued March 2015.
Guidance for Oxygen Conserving Device 510(k) Review 73 BZD 868.5905 Non-continuous Ventilator Class II, issued February 1989.
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. |
