| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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056
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Date of Entry 06/07/2021
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FR Recognition Number
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9-137
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| 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 |
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Identical AdoptionANSI 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 |
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Scope/AbstractThis 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.
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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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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
|
| §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
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| §876.5820 |
System, Dialysate Delivery, Single Pass
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Class 2
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FIL
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| §876.5820 |
Solution-Test Standard-Conductivity, Dialysis
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Class 2
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FKH
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| §876.5820 |
System, Dialysate Delivery, Single Patient
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Class 2
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FKP
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| §876.5820 |
System, Dialysate Delivery, Central Multiple Patient
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Class 2
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FKQ
|
| §876.5820 |
Subsystem, Proportioning
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Class 2
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FKR
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| §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
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| §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
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| §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
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Class 2
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FII
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| §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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