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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Recognition 01/30/2014 
FR Recognition Number 1-96
Standard
ISO 80601-2-55 First edition 2011-12-15
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
Extent of Recognition
Complete standard
Transition Period
FDA recognition of ISO 80601-2-55 First edition 2011-12-15 [Rec# 1-96] will be superseded by recognition of ISO 80601-2-55 Second edition 2018-02 [Rec# 1-140]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-96] until September 28, 2019. After this transition period, declarations of conformity to [Rec# 1-96] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§868.1720 Analyzer, Gas, Oxygen, Gaseous-Phase Class 2 CCL
§868.1700 Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Class 2 CBR
§868.1690 Analyzer, Gas, Nitrogen, Gaseous-Phase Class 2 CCI
§868.1620 Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Class 2 CBS
§868.1500 Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Class 2 CBQ
§868.1400 Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Class 2 CCK
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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