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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 052 Date of Recognition 07/15/2019 
FR Recognition Number 1-116
Standard
ISO 5360 Fourth edition 2016-02-15
Anaesthetic vaporizers - Agent specific filling systems
Scope/Abstract
ISO 5360:2016 specifies requirements, including dimensions, for agent-specific filling systems for agent-specific anaesthetic vaporizers.

ISO 5360:2016 does not specify construction materials.

NOTE 1 For recommendations on materials, see Annex A.

Because of the unique properties of desflurane, dimensions for this agent have not been specified in this International Standard.

NOTE 2 Designs of connection systems, which only permit engagement of the agent-specific bottle adaptor to the bottle when the bottle collar is in place, are encouraged.

Extent of Recognition
Complete standard
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.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§868.5880 Vaporizer, Anesthesia, Non-Heated Class 2 CAD
§868.5160 Gas-Machine, Anesthesia Class 2 BSZ
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 Neel Patel
  FDA/OMPT/CDRH/ODE/DAGID/ANDB/
  301-796-6274
  Neel.Patel@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Anesthesiology
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