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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 1-86: ISO 8185 Third edition 2008-06-15 (Corrected version), respiratory tract humidifiers for medical use - particular requirements for respiratory humidification systems. (Anesthesias)

Date of Standard: 2008. 
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)
DIV OF ANESTHESIOLOGY,GEN. HOSPITAL, INFECTION CONTROL & DENTAL DEVICE (DAGRID)
Devices Affected:
Humidification systems, including accessories (e.g. breathing tubes, temperature sensors, etc.) that are intended to raise the water content of gases delivered to the patient.
Processes Affected:
510(k), PMA, IDE, PDP, HDE, Design Control Input
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard with the following exceptions:

Clause 44.7 Cleaning, sterilization and disinfection is not recognized
Clause 46 Human error is not recognized
Clause 102.1 Dimensional requirements is not recognized
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§868.5270 Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer Class 2 BZE
§868.5450 Humidifier, Respiratory Gas, (Direct Patient Interface) Class 2 BTT
§868.5895 Ventilator, Continuous, Facility Use Class 2 CBK
§868.5905 Ventilator, Non-Continuous (Respirator) Class 2 BZD
Relevant Guidance:
FDA Heated Humidifier Review Guide, 1997

Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, May 2011

Draft Guidance for Industry and FDA Staff: Applying Human Factors and Usability Engineering to Optimize Medical Device Design, June 2011

Draft Guidance for Industry and FDA Staff: 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device, July 2011
FDA Technical Contact:
 Sugato De
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2552
  Silver Spring MD 20993
  301/796-6270
  email: sugato.de@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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