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

Part B: Supplementary Information

Recognition Number 9-91: AAMI / ANSI / ISO 8637:2010, cardiovascular implants and extracorporeal systems - hemodialyzers, hemodiafilters, hemofilters, and hemoconcentrators [including: amendment 1 (2013)]. (ObGyn/Gastroenterology/Urology)

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
CDRH Office and Division associated with recognized standards:
Devices Affected:
Hemodialyzers, Hemoconcentrators, Hemofilters, Hemodiafilters
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:

6.1 NOTE is not recognized

6.2e NOTE is not recognized

6.2 NOTE is not recognized

6.3 NOTE is not recognized

6.4 Third NOTE is not recognized
Related CFR Citations and Product Codes:
Device Name Device
§876.5820 Dialyzer, Capillary, Hollow Fiber Class 2 FJI
§876.5820 Dialyzer, Parallel Flow Class 2 FJG
§876.5820 Dialyzer, Single Coil Class 2 FHS
§876.5820 Dialyzer, Twin Coil Class 2 FJJ
§876.5820 Filter, Blood, Dialysis Class 2 FKJ
§876.5860 Dialyzer, High Permeability With Or Without Sealed Dialysate System Class 2 KDI
Relevant Guidance:
Guidance for Industry and CDRH Reviewers, Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers. Issued on August 7, 1998 for Sections 4.5.1, 4.5.2, 4.5.3, and of the standard.

FDA Blue Book Memorandum #G95-1: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." for Section 5.2
FDA Technical Contacts:
 Carolyn Neuland
  10903 New Hampshire Avenue WO66 RMG226
  Silver Spring MD 20993
  email: carolyn.neuland@fda.hhs.gov
 Gema Gonzalez
  10903 New Hampshire Avenue WO66 RMG220
  Silver Spring MD 20993
  email: gema.gonzalez@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