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U.S. Department of Health and Human Services

Recognized Consensus Standards

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FR Publication Date: 01/30/2014 

Part B: Supplementary Information

AAMI / ANSI RD52:2004, dialysate for hemodialysis. (ObGyn/Gastroenterology)
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
 
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Hemodialysis Water Purification Systems for Dialysis, Hemodialysis Systems
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Quality System Regulations
Type of Standard:
 Vertical, National
Extent of Recognition:
ONLY - Section 4.1, 4.3.1, 4.3.2, 4.3.2.1, and 4.3.3.2 - Water and dialysate bacteriology and levels of chemical contaminants
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§876.5665 Disinfectant, Subsystem, Water Purification Class 2 NIH
§876.5665 Subsystem, Water Purification Class 2 FIP
§876.5665 System, Water Purification, General Medical Use Class 2 NHV
§876.5820 Meter, Conductivity, Induction, Remote Type Class 2 FLB
§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 Solution-Test Standard-Conductivity, Dialysis Class 2 FKH
§876.5820 Strip, Dialysate Ph Indicator Class 2 MNV
§876.5820 Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator Class 2 NTZ
§876.5820 Subsystem, Proportioning Class 2 FKR
§876.5820 System, Dialysate Delivery, Central Multiple Patient Class 2 FKQ
§876.5820 System, Dialysate Delivery, Recirculating Class 2 FIK
§876.5820 System, Dialysate Delivery, Recirculating, Single Pass Class 2 FIJ
§876.5820 System, Dialysate Delivery, Single Pass Class 2 FIL
§876.5820 System, Dialysate Delivery, Single Patient Class 2 FKP
§876.5860 Disinfectant, Dialysate Delivery System Class 2 NII
§876.5860 System, Dialysate Delivery, Sealed Class 2 FII
Relevant Guidance:
Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis. Issued May 30, 1997

Regulatory Status of Disinfectants Used to Process Dialysate Delivery Systems and Water Purification Systems for Hemodialysis; Guidance for Industry and FDA. Issued August 30, 2002.
FDA Technical Contacts:
 Gema Gonzalez
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room G220
  Silver Spring MD 20993
  301/796-6519
  email: gema.gonzalez@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
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