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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 1-94: ISO 8359 Second edition 1996-12-15, oxygen concentrators for medical use - safety requirements [including amendment 1 (2012)]. (Anesthesias)

Date of Standard: 1996. 
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)
DIV OF ANESTHESIOLOGY,GEN. HOSPITAL, INFECTION CONTROL & DENTAL DEVICE (DAGRID)
Devices Affected:
Oxygen concentrators excluding those intended to supply gas to several patients via a piped medical gas installation or those intended for use in the presence of flammable anesthetic or cleaning agents or both.
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Design Control Input
Type of Standard:
 International, Vertical
Extent of Recognition:
Complete standard with the following exceptions:

Clause 26 is not recognized
Clause 36 is not recognized
Clause 42.1 is not recognized
Clause 47 is not recognized
Clause 48 is not recognized
Clause 53 is not recognized
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§868.5440 Generator, Oxygen, Portable Class 2 CAW
FDA Technical Contact:
 Amy Levelle
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2547
  Silver Spring MD 20993
  301/796-6963
  email: amy.levelle@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
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