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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 1-58: ASTM G175-03 (Reapproved 2011), standard test method for evaluating the ignition sensitivity and fault tolerance of oxygen regulators used for medical and emergency applications. (Anesthesias)

Date of Standard: 2003. 
Address of Standards Development Organization:
 ASTM International (ASTM)
  100 Barr Harbor Drive
  West Conshohocken, PA 19428-2959
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF COMPLIANCE (OC)
Devices Affected:
Oxygen Regulators, Oxygen Conserving devices that incorporate an integral regulator
Processes Affected:
Design Control Inputs, Premarket notification
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§868.2700 Regulator, Pressure, Gas Cylinder Class 1 CAN
§868.5905 Conserver, Oxygen Class 2 NFB
FDA Technical Contact:
 Chan Lee
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2543
  Silver Spring MD 20993
  301/796-6267
  email: chan.lee@fda.hhs.gov
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