| 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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9-135
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| Standard | |
ISO 23500-3 First edition 2019-02
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies |
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Identical AdoptionANSI AAMI ISO 23500-3:2019
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies |
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Scope/AbstractThis document specifies minimum requirements for water to be used in haemodialysis and related therapies.
This document includes water to be used in the preparation of concentrates, dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration, and for the reprocessing of haemodialysers.
This document excludes the operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid. Those operations are the sole responsibility of dialysis professionals. This document does not apply to dialysis fluid regenerating systems.
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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 |
| §876.5630 |
Catheter, Peritoneal Dialysis, Single Use
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Class 2
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FKO
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| §876.5665 |
Subsystem, Water Purification
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Class 2
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FIP
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| §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
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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 |
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
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| §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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