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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 1-82: IEC 60601-2-13 Edition 3.1 2009-08, medical electrical equipment - part 2-13: particular requirements for the safety and essential performance of anaesthetic systems. (Anesthesias)

Date of Standard: 2009. 
Address of Standards Development Organization:
 International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  CH-1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Anesthesia machines incorporating electrical devices designed for medical use including those which incorporate lung ventilators and lung ventilators intended for use with inhalation anesthetic agents.
Processes Affected:
510(k), Design Control Input
Type of Standard:
 International, Vertical
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§868.5160 Gas-Machine, Anesthesia Class 2 BSZ
Relevant Guidance:
Draft Reviewer Guidance for Ventilators, July 1995

Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance, April 1996
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
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