| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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066
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Date of Entry 05/25/2026
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FR Recognition Number
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9-156
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| Standard | |
ISO 23500-5 Second edition 2024-04
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies |
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Scope/AbstractThis document specifies the minimum chemical and microbiological quality requirements for dialysis fluids used in haemodialysis and related therapies.
This document applies to
- dialysis fluids used for haemodialysis and haemodiafiltration,
- substitution fluid produced online for haemodiafiltration and haemofiltration based on dialysis fluid
This document does not apply to
- the water and concentrates used to prepare dialysis fluid or the equipment to produce dialysis fluid
- 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.
The delivery and monitoring of the dialysis fluid composition and its permitted deviation from set points is governed by protective systems defined in IEC 60601-2-16. |
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| Extent of Recognition
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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 |
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Transition Period
| FDA recognition of ISO 23500-5 First edition 2019-02 [Rec# 9-137] will be superseded by recognition of ISO 23500-5 Second edition 2024-04 [Rec# 9-156]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 9-137] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 9-137] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §876.5665 |
Subsystem, Water Purification
|
Class 2
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FIP
|
| §876.5665 |
System, Water Purification, General Medical Use
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Class 2
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NHV
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| §876.5665 |
Disinfectant, Subsystem, Water Purification
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Class 2
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NIH
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| §876.5820 |
Set, Dialysis, Single Needle With Uni-Directional Pump
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Class 2
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FIF
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| §876.5820 |
System, Dialysate Delivery, Recirculating, Single Pass
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Class 2
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FIJ
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| §876.5820 |
System, Dialysate Delivery, Recirculating
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Class 2
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FIK
|
| §876.5820 |
System, Dialysate Delivery, Single Pass
|
Class 2
|
FIL
|
| §876.5820 |
Solution-Test Standard-Conductivity, Dialysis
|
Class 2
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FKH
|
| §876.5820 |
System, Dialysate Delivery, Single Patient
|
Class 2
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FKP
|
| §876.5820 |
System, Dialysate Delivery, Central Multiple Patient
|
Class 2
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FKQ
|
| §876.5820 |
Subsystem, Proportioning
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Class 2
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FKR
|
| §876.5820 |
Meter, Conductivity, Induction, Remote Type
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Class 2
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FLB
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| §876.5820 |
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
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Class 2
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KPO
|
| §876.5820 |
Strip, Dialysate Ph Indicator
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Class 2
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MNV
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| §876.5820 |
Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed
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Class 2
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NNG
|
| §876.5820 |
Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator
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Class 2
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NTZ
|
| §876.5860 |
System, Dialysate Delivery, Sealed
|
Class 2
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FII
|
| §876.5860 |
Disinfectant, Dialysate Delivery System
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Class 2
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NII
|
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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. |
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| FDA Technical Contact
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| Standards Development Organization
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FDA Specialty Task Group (STG)
| ObGyn/Gastroenterology/Urology |
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| *These are provided as examples and others may be applicable. |
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