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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 1-70: ASTM F 1246-91 (Reapproved 2005), standard specification for electrically powered home care ventilators, part 1 - positive-pressure ventilators and ventilator circuits. (Anesthesias)

Date of Standard: 1991. 
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 COMPLIANCE (OC)
(2)OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB)
DIVISION OF POSTMARKET SURVEILLANCE (DPS)
(3)OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Home Care Ventilators and Ventilator Circuits
Processes Affected:
Design Control Inputs, Premarket Notification
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete standard with the following exceptions:

Clause 3.1.5 home environment is not recognized
Clause 4.1.1 Electrical Safety is not recognized
Clause 4.8 Human Factors Requirements is not recognized
Clause 5.1.4 is not recognized
Clause 6.1.1 is not recognized
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§868.5895 Continuous, Ventilator, Home Use Class 2 NOU
§868.5975 Set, Tubing And Support, Ventilator (W Harness) Class 1 BZO
Relevant Guidance:
Draft Guidance for Industry and FDA Staff - Design Considerations for Devices Intended for Home Use, December 2012

Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design, June 2011

Draft Guidance for Industry and FDA Staff - Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, May 2011

Draft Reviewer Guidance for Ventilators, July 1995

Guidance on Medical Device Patient Labeling, April 2001
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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