| 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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9-152
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| Standard | |
ISO 23500-1 Second edition 2024-08
Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements |
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Scope/AbstractThis document specifies the general requirements for the preparation of fluids for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration, for dialysis practitioners. This document gives guidance on the user's responsibility for fluids used in haemodialysis and related therapies once the equipment used in its preparation has been delivered and installed. As dialysis water used to prepare dialysis fluid can also be used to reprocess dialysers not marked intended for single use, this aspect of water use is also covered by this document.
This document is applicable to
- the quality management of equipment used to treat and distribute water used for the preparation of dialysis fluid and substitution fluid, from the point at which municipal water enters the dialysis facility to the point at which the final dialysis fluid enters the dialyser or the point at which substitution fluid is infused.
- the quality management of the equipment used to prepare acid and bicarbonate concentrate from powdered or other highly concentrated media at a dialysis facility, and
- the preparation of the final dialysis fluid or substitution fluid from dialysis water and concentrates.
This document does not apply to
- 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.
This document does not address clinical issues associated with inappropriate usage of such fluids*. |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
Section 7.5 Surveillance of concentrate distribution - Third paragraph, first sentence "There are no published reports of acid concentrate supporting bacterial growth; therefore, it is not necessary to perform routine testing for total viable microbial count and endotoxins on those systems."
Section 8.2.3.4 Concentrate distribution systems - Second paragraph, third sentence "As there are no published reports of acid concentrate supporting bacterial growth, the disinfection of acid concentrate distribution systems is not normally required."
Section B.5.3.2 Acid concentrate distribution systems - Last two sentences "Even though there are no published reports of acid concentrate supporting microbial growth, every effort should be made to keep the system closed to prevent contamination and evaporation. If the acid system remains intact, no rinsing or disinfection is necessary." |
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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.
Please note that this standard is mainly a user standard and it contains specifications and recommendations that are beyond the regulatory jurisdiction of FDA as they are directed to the safe conduct of dialysis clinics and home hemodialysis programs. FDA does not regulate practice of medicine.
Please also note that Section 3.31 (non-pyrogenic) "Note 2 to entry" may not apply to every instance. For example, it may be difficult to meet the threshold pyrogenic dose of 5 EU/kg/h for small weight patients undergoing treatment with modalities where priming and/or substitution fluid is produced online; therefore, care must be taken in those instances. We encourage you to contact the review division regarding appropriate testing for your device.
This standard is recognized in part because:
The above identified sentences in Sections 7.5, 8.2.3.4 and B.5.3.2 are not scientifically justified. Microbial growth, including both bacteria and fungi, has been detected in the microbial test of acid concentrate (see "Relevant FDA Guidance and/or Supportive Publications" reference #3). In addition, microbial growth is also known to occur in highly acidic food products and is directly addressed in the FDA Bacteriological Analytical Manual (BAM) and 21 CFR Part 114 (see "Relevant Public Law, CFR Citations" and "Relevant FDA Guidance and/or Supportive Publications" references #3 & #4). |
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Transition Period
| FDA recognition of ISO 23500-1 First edition 2019-02 [Rec# 9-133] will be superseded by recognition of ISO 23500-1 Second edition 2024-08 [Rec# 9-152]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 9-133] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 9-133] 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
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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 |
System, Dialysate Delivery, Central Multiple Patient
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Class 2
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FKQ
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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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| 21 CFR Part 114 Acidified Foods, General Provisions, Definitions, Scheduled process |
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Relevant FDA Guidance and/or Supportive Publications*
1. Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis, issued May 1997.
2. Regulatory Status of Disinfectants Used to Process Dialysate Delivery Systems and Water Purification Systems for Hemodialysis; Guidance for Industry and FDA, issued August 2002.
3. Diasol, Inc. - 719460 - 01/29/2026 - Section 6Bi | FDA (microbial growth in an acid concentrate).
4. Bacteriological Analytical Manual (BAM) Chapter 18: Yeasts, Molds, and Mycotoxins - April 2001 Ed| FDA (processes and controls of Yeasts and Molds in an acidified environment, "Introduction").
5. 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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