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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Recognition 08/21/2017 
FR Recognition Number 1-124
Standard
ISO 8835-7 First edition 2011-11-01
Inhalational anaesthesia systems - Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases
Scope/Abstract
ISO 8835-7:2011 specifies safety and performance requirements for anaesthetic systems and components that:

- can function in the absence of a supply of compressed medical gases or mains electricity;

- can withstand a challenging environment, including high temperatures, humidity, shocks and vibration, and dust;

- allow local servicing and maintenance;

- may be suitable for use with flammable anaesthetic agents.

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, 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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