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Recognized Consensus Standards
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Recognition List Number: 029 Publication Date: 08/20/2012 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 1-88: ISO 80601-2-12 First edition 2011-04-15, Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators. (Anesthesias)

Date of Standard: 2001. 
Address of Standards 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:
Lung ventilators incorporating electrical devices designed for medical use excluding lung ventilators specified for use with inhalation anesthetic agents.
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Design Control Input
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard with the following exceptions:

Clause 206 does not apply. IEC 62366:2007 applies. Refer to draft guidance for Applying Human Factors and Usability Engineering to Optimize Medical Device Design
Related CFR Citations and Product Codes:
Regulation
Number		 Device Name Device
Class		 Product
Code
§868.5895 Ventilator, Continuous, Facility Use Class 2 CBK
§868.5895 Ventilator, Continuous, Minimal Ventilatory Support,Facility Use Class 2 MNT
§868.5895 Ventilator, Continuous, Non-Life-Supporting Class 2 MNS
 
Relevant Guidance:
Draft Reviewer Guidance for Ventilators, July 1995

Labelling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance, April 1999
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices: May 2005
Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design: June 22, 2011
FDA Technical Contact:
  Bahram Parvinian
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2534
  Silver Spring MD 20993
  301/796-6445
  Email: bahram.parvinian@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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