• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 

New Search Back To Search Results
Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 1-96: 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. (Anesthesias)

Date of Standard: 2011. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Respiratory gas monitor (RGM) - medical electrical equipment intended to measure that gas level(s) or partial pressure(s) in respiratory gases, for example, anesthetic gas monitoring, carbon dioxide monitoring, and oxygen monitoring. The RGM consists of a complete monitor including accessories, sensor, and sampling tube (in the case of a diverting respiratory gas monitor) specified by the manufacturer
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Design Control Input
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard and any annexes.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§868.1400 Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Class 2 CCK
§868.1500 Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Class 2 CBQ
§868.1620 Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Class 2 CBS
§868.1690 Analyzer, Gas, Nitrogen, Gaseous-Phase Class 2 CCI
§868.1700 Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Class 2 CBR
§868.1720 Analyzer, Gas, Oxygen, Gaseous-Phase Class 2 CCL
FDA Technical Contact:
 Neel Patel
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2532
  Silver Spring MD 20993
  301/796-6274
  email: neel.patel@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
-
-