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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 9-99
Standard
ISO 23500 Second edition 2014-04-01
Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
U.S. Identical Adoption
ANSI AAMI ISO 23500:2014
Guidance for the preparation and quality management of fluids for hemodialysis and related therapies
Scope/Abstract
ISO 23500:2014 provides dialysis practitioners with guidance on the preparation of dialysis fluid for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration. As such, ISO 23500:2014 functions as a recommended practice.

ISO 23500:2014 addresses the user's responsibility for the dialysis fluid once the equipment used in its preparation has been delivered and installed. For the purposes of ISO 23500:2014, the dialysis fluid includes dialysis water used for the preparation of dialysis fluid and substitution fluid, dialysis water used for the preparation of concentrates at the user's facility, as well as concentrates and the final dialysis fluid and substitution fluid.

Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized
Sections 1,2,3,4.4, 6,7, 8 and Annexes.
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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