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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 040 Date of Recognition 08/14/2015 
FR Recognition Number 9-100
Standard
ISO 11663 Second edition 2014-04-01
Quality of dialysis fluid for haemodialysis and related therapies
U.S. Identical Adoption
ANSI AAMI ISO 11663:2014
Quality of dialysis fluid for hemodialysis and related therapies
Scope/Abstract
ISO 11663:2014 specifies minimum quality requirements for dialysis fluids used in haemodialysis and related therapies.

ISO 11663:2014 includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration.

Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized
Section 3.28.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§876.5860 Disinfectant, Dialysate Delivery System Class 2 NII
§876.5860 System, Dialysate Delivery, Sealed Class 2 FII
§876.5820 Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Class 2 KPO
§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
§876.5665 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
Relevant FDA Guidance and/or Supportive Publications
Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis, Issued May 1997.
Regulatory Status of Disinfectants Used to Process Dialysate Delivery Systems and Water Purification Systems for Hemodialysis; Guidance for Industry and FDA, Issued August 2002.
FDA Technical Contacts
 Carolyn Neuland
  FDA/OMPT/CDRH/ODE/DRGUD/RNDB/
  301-796-6523
  carolyn.neuland@fda.hhs.gov
 Gema Gonzalez
  FDA/OMPT/CDRH/ODE/DRGUD/RNDB/
  301-796-6519
  gema.gonzalez@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
ObGyn/Gastroenterology/Urology
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