| 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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9-155
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| Standard | |
ISO 23500-4 Second edition 2024-04
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies |
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Scope/AbstractThis document specifies the chemical and microbiological requirements for concentrates used for haemodialysis and related therapies and applies to the manufacturer of such concentrates.
This document is applicable to:
- concentrates in both liquid and powder forms;
- additives, also called spikes, which are chemicals that can be added to the concentrate to supplement or increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid;
- equipment used to mix acid and bicarbonate powders into concentrate at the user's facility.
This document does not apply to:
- concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility;
- pre-packaged and sterile dialysis fluid;
- sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid;
- equipment to perform patient treatment; this is addressed IEC 60601-2-16.
This document does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid is covered in ISO 23500-5. The making of dialysis fluid involves the proportioning of concentrate and water at the bedside or in a central dialysis fluid delivery system. Although the label requirements for dialysis fluid are placed on the labelling of the concentrate, it is the user's responsibility to ensure proper use. |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
Section 4.1.3.1 Bacteriology of acid concentrates
Section 4.3.7 Piping systems - Last sentence "The disinfection of piping systems for acid concentrate is normally not necessary because acid concentrates are typically bacteriostatic." |
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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.
This standard is recognized in part because:
Section 4.1.3.1 and the identified sentence in Section 4.3.7 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 23500-4 First edition 2019-02 [Rec# 9-136] will be superseded by recognition of ISO 23500-4 Second edition 2024-04 [Rec# 9-155]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 9-136] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 9-136] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §876.5820 |
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
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Class 2
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KPO
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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 (Report of microbial growth in an acid concentrate).
4. Bacteriological Analytical Manual (BAM) Chapter 18: Yeasts, Molds, and Mycotoxins - April 2001 Ed| FDA (Recognized need for 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. |
