| 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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9-153
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| Standard | |
ISO 23500-2 Second edition 2024-07
Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies |
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Scope/AbstractThis document specifies requirements and recommendations for individual water treatment devices and water treatment systems assembled from one or more of such devices. This document is directed at the individual or company that specifies the complete water treatment system and, the supplier who assembles and installs the system. Since systems can be assembled from a number of individual water treatment devices, the provisions of this document are also directed at the manufacturers of these devices, provided that the manufacturer indicates that the device is intended to be used to supply water for haemodialysis and related therapies.
This document is applicable to all devices, piping and fittings between the point at which water is delivered to the water purification system and the point of use of the purified water. Such components include but are not necessarily limited to water purification devices, online water quality monitors (such as conductivity monitors) and piping systems for the distribution of purified water.
This document does not apply to
- equipment used in the preparation of concentrates from powder or other highly concentrated media at a dialysis facility either for a single patient or multiple patients,
- dialysis fluid supply systems that proportion water and concentrates to produce dialysis fluid,
- sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid,
- dialysis concentrates,
- haemodiafiltration or haemofiltration systems,
- systems that process dialysers for multiple uses, and
- peritoneal dialysis systems.
Requirements for the ongoing monitoring of water purity in terms of chemical and microbiological quality are given in ISO 23500-3. |
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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 23500-2 First edition 2019-02 [Rec# 9-134] will be superseded by recognition of ISO 23500-2 Second edition 2024-07 [Rec# 9-153]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 9-134] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 9-134] 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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Relevant FDA Guidance and/or Supportive Publications*
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. |
