• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • 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 056 Date of Entry 06/07/2021 
FR Recognition Number 9-137
Standard
ISO 23500-5 First edition 2019-02
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies
U.S. Identical Adoption
ANSI AAMI ISO 23500-5:2019
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies
Scope/Abstract
This document specifies minimum quality requirements for dialysis fluids used in haemodialysis and related therapies.

This document includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration.

This document excludes the water and concentrates used to prepare dialysis fluid or the equipment used in its preparation. Those areas are covered by other International Standards.

Sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, systems for continuous renal replacement therapy that use pre-packaged solutions, and systems and solutions for peritoneal dialysis are excluded from this document.
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FDA recognition of ISO 11663 Second edition 2014-04-01 [Rec# 9-100] will be superseded by recognition of ISO 23500-5 First edition 2019 [Rec# 9-137]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 9-100] until July 10, 2022. After this transition period, declarations of conformity to [Rec# 9-100] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
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 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
§876.5860 Disinfectant, Dialysate Delivery System Class 2 NII
§876.5860 System, Dialysate Delivery, Sealed Class 2 FII
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
 Gema Gonzalez
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIA/
  301-796-6519
  gema.gonzalez@fda.hhs.gov
 Carolyn Neuland
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIA/
  301-796-6523
  carolyn.neuland@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.
-
-