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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 031 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 1-91: ISO 5360 Third edition 2012-01-15, anaesthetic vaporizers - agent specific filling systems. (Anesthesias)

Date of Standard: 2012. 
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:
Agent-Specific Anesthesia Vaporizers
Processes Affected:
510(K), IDE, Design Control Input
Type of Standard:
 International, Vertical
Extent of Recognition:
Complete standard, with the following exceptions:

Clauses 4, 5, 6, 7 and 11 (and associated tables and figures) are not recognized as the agent bottle, bottle collar, and bottle adapters are regulated by Center of Drug Evaluation and Research (CDER).

Clause 8 is not recognized.

Clause 10 is not recognized, refer to ASTM F 1161 clause 12.1.11.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§868.5160 Gas-Machine, Anesthesia Class 2 BSZ
§868.5880 Vaporizer, Anesthesia, Non-Heated Class 2 CAD
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
* 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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