Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 066 Date of Entry 05/25/2026 
FR Recognition Number 9-154
Standard
ISO  23500-3 Second edition 2024-04
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
Scope/Abstract
This document specifies the minimum chemical and microbiological quality requirements, for water used for preparation of dialysis fluids, concentrates, and for the reprocessing of haemodialysers, together with the necessary steps to ensure conformity with the requirements. The document also provides guidance for the ongoing monitoring of the purity of such water in terms of chemical and microbiological quality.
This document is applicable to
- water used in the preparation of dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration and the reprocessing of haemodialysers, and
- water used in the preparation of concentrates.
This document does not apply to dialysis fluid regenerating systems.
The operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid are the sole responsibility of dialysis professionals.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of ISO 23500-3 First edition 2019-02 [Rec# 9-135] will be superseded by recognition of ISO 23500-3 Second edition 2024-04 [Rec# 9-154]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 9-135] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 9-135] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§876.5630 Catheter, Peritoneal Dialysis, Single Use Class 2 FKO
§876.5665 Subsystem, Water Purification Class 2 FIP
§876.5665 System, Water Purification, General Medical Use Class 2 NHV
§876.5665 Disinfectant, Subsystem, Water Purification Class 2 NIH
§876.5820 Set, Dialysis, Single Needle With Uni-Directional Pump Class 2 FIF
§876.5820 System, Dialysate Delivery, Recirculating, Single Pass Class 2 FIJ
§876.5820 System, Dialysate Delivery, Recirculating Class 2 FIK
§876.5820 System, Dialysate Delivery, Single Pass Class 2 FIL
§876.5820 Solution-Test Standard-Conductivity, Dialysis Class 2 FKH
§876.5820 System, Dialysate Delivery, Single Patient Class 2 FKP
§876.5820 Subsystem, Proportioning Class 2 FKR
§876.5820 Meter, Conductivity, Induction, Remote Type Class 2 FLB
§876.5820 Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Class 2 KPO
§876.5820 Strip, Dialysate Ph Indicator Class 2 MNV
§876.5820 Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed Class 2 NNG
§876.5820 Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator Class 2 NTZ
§876.5860 System, Dialysate Delivery, Sealed Class 2 FII
§876.5860 Disinfectant, Dialysate Delivery System Class 2 NII
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.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Gema Gonzalez
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIA/
  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
*These are provided as examples and others may be applicable.
-
-