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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 1-57: ASTM F1101-90 (Reapproved 2003), standard specification for ventilators intended for use during anesthesia. (Anesthesias)

Date of Standard: 2003. 
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)
(3)OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Anesthesia Gas Machines
Processes Affected:
Vigilance Reporting, Premarket Notification
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete standard with the following exceptions:

Clause 4.1 Sterilization or Decontamination or Both is not recognized
Clause 5.1 Volume and Wave-Form is not recognized
Clause 5.9.2 is not recognized
Clause 5.9.5 is not recognized
Clause 5.10 Mechanical Stability and Transportability is not recognized
Clause 8.1.1 is not recognized
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§868.5160 Gas-Machine, Anesthesia Class 2 BSZ
§868.5430 Apparatus, Gas-Scavenging Class 2 CBN
§868.5975 Set, Tubing And Support, Ventilator (W Harness) Class 1 BZO
Relevant Guidance:
Updated 510(K) Sterility Review Guidance K90-1; Final Guidance for Industry and FDA

Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, ,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Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design: June 22, 2011

Labeling - Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance, April 1999

Reviewer Guidance, Excerpts related to EMI from November 1993

Draft Reviewer Guidance for Ventilators
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
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