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Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 9-66: AAMI / ANSI / ISO 8638:2010, cardiovascular implants and extracorporeal blood circuit for hemodialyzers, hemodiafilters, and hemofilters. (ObGyn/Gastroenterology)

Date of Standard: 2010. 
Addresses of Standards Development Organizations:
 Association for the Advancement of Medical Instrumentation (AAMI)
  4301 North Fairfax Drive
  Suite 301
  Arlington, VA 22203
 
 American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
 
 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:
Hemodialyzer blood tubing, hemodialysis systems
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Quality System Regulations
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard with the following exceptions:

Section 4.4.9.1 is not recognized

Section 4.4.9.2 is not recognized

Section 5.5.6.1 is not recognized

Section 5.5.6.2 is not recognized

Section 5.5.9 is not recognized

Section 5.5.10 is not recognized

Section 6.1 NOTE is not recognized

Section 6.2e NOTE is not recognized

Section 6.2 NOTE is not recognized

Section 6.3 NOTE is not recognized

Section 6.4 NOTE is not recognized
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§876.5820 Accessories, Blood Circuit, Hemodialysis Class 2 KOC
§876.5820 Adaptor, Fistula Class 2 FKM
§876.5820 Adaptor, Y Class 2 FJP
§876.5820 Connector, Blood Tubing, Infusion T Class 2 FKB
§876.5820 Connector, Tubing, Dialysate Class 2 FKY
§876.5820 Declotting Tray, Kit (Including Contents) Class 2 FJZ
§876.5820 Filter, Blood, Dialysis Class 2 FKJ
§876.5820 Protector, Transducer, Dialysis Class 2 FIB
§876.5820 Set, Dialysis, Single Needle With Uni-Directional Pump Class 2 FIF
§876.5820 Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed Class 2 NNG
§876.5820 Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Class 2 FJK
§876.5820 System Accessories, Extracorporeal Class 2 KXM
§876.5820 System, Blood, Extracorporeal And Accessories Class 2 LLB
§876.5820 Tray, Start/Stop (Including Contents), Dialysis Class 1 FKG
§876.5820 Tubing, Dialysate Class 2 FID
§876.5820 Tubing, Dialysate (And Connector) Class 2 KQQ
Relevant Guidance:
Guidance for Industry and FDA Staff, Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions. Issued April 23, 2008

FDA Blue Book Memorandum #G95-1: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing."
FDA Technical Contacts:
 David Pudwill
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room G225
  Silver Spring MD 20993
  301/796-6526
  email: david.pudwill@fda.hhs.gov
 Carolyn Neuland
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room G226
  Silver Spring MD 20993
  301/796-6523
  email: carolyn.neuland@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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