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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Recognition 01/14/2019 
FR Recognition Number 1-114
Standard
ISO 18835 First Edition 2015-04-01
Inhalational Anaesthesia Systems - Draw-over Anaesthetic Systems
Scope/Abstract
ISO 18835:2015 specifies basic safety and essential performance requirements for anaesthetic systems utilizing the draw-over method to provide inhalational anaesthesia.

Requirements are included to allow the use of these systems with both non-flammable and flammable anaesthetic agents.

ISO 18835:2015 also includes requirements for a bellows-type manual ventilator.

NOTE 1 Requirements for automatic anaesthetic ventilators are covered by ISO 80601 2-13.

NOTE 2 Requirements for operator-powered self-inflating bags are covered by ISO 10651 4.

ISO 18835:2015 does not specify requirements for monitoring of the equipment or the patient.

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
§868.5160 Gas-Machine, Anesthesia Class 2 BSZ
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.
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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