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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 056 Date of Entry 06/07/2021 
FR Recognition Number 9-133
ISO  23500-1 First edition 2019-02
Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements
Identical Adoption
ANSI AAMI ISO 23500-1:2019
Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements
1.1 General
This document is the base standard for a number of other standards dealing with water treatment equipment, water, dialysis water, concentrates, and dialysis fluid (ISO 23500 series) and provides dialysis practitioners with guidance on the preparation of dialysis fluid for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration. As such, this document functions as a recommended practice.

This document does not address clinical issues that might be associated with inappropriate usage of the water, dialysis water, concentrates, or dialysis fluid. Healthcare professionals involved in the provision of treatment for kidney failure should make the final decision regarding the applications with which these fluids are used, for example, haemodialysis, haemodiafiltration, high-flux haemodialysis, and the reprocessing of dialysers, and need to be aware of the issues that the use of inappropriate fluid quality raises in each of the therapies.

The concepts incorporated in this document should not be considered inflexible or static. The recommendations presented here should be reviewed periodically in order to assimilate increased understanding of the role of dialysis fluid purity in patient outcomes and technological developments.

1.2 Inclusions
This document addresses the user's responsibility for dialysis fluid once the equipment used in its preparation has been delivered and installed.

For the purposes of this document, dialysis fluid includes:
a) dialysis water (see 3.17 for definition) used for the preparation of dialysis fluid and substitution fluid,
b) dialysis water used for the preparation of concentrates at the user's facility,
c) concentrates,
d) the final dialysis fluid and substitution fluid.

The scope of this document includes
a) 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,
b) equipment used to prepare concentrate from powder or other highly concentrated media at a dialysis facility, and
c) preparation of the final dialysis fluid or substitution fluid from dialysis water and concentrates.

NOTE Because 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.

1.3 Exclusions
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.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Note 2 of Section 3.32 (non-pyrogenic)
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.

This standard is recognized in part because:

Note 2 of Section 3.32 (non-pyrogenic) is contradictory. 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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§876.5665 Subsystem, Water Purification Class 2 FIP
§876.5665 System, Water Purification, General Medical Use Class 2 NHV
§876.5665 Disinfectant, Subsystem, Water Purification Class 2 NIH
§876.5820 Set, Dialysis, Single Needle With Uni-Directional Pump Class 2 FIF
§876.5820 System, Dialysate Delivery, Recirculating, Single Pass Class 2 FIJ
§876.5820 System, Dialysate Delivery, Recirculating Class 2 FIK
§876.5820 System, Dialysate Delivery, Single Pass Class 2 FIL
§876.5820 Solution-Test Standard-Conductivity, Dialysis Class 2 FKH
§876.5820 System, Dialysate Delivery, Single Patient Class 2 FKP
§876.5820 System, Dialysate Delivery, Central Multiple Patient Class 2 FKQ
§876.5820 Subsystem, Proportioning Class 2 FKR
§876.5820 Meter, Conductivity, Induction, Remote Type Class 2 FLB
§876.5820 Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Class 2 KPO
§876.5820 Strip, Dialysate Ph Indicator Class 2 MNV
§876.5820 Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed Class 2 NNG
§876.5820 Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator Class 2 NTZ
§876.5860 System, Dialysate Delivery, Sealed Class 2 FII
§876.5860 Disinfectant, Dialysate Delivery System Class 2 NII
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.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Gema Gonzalez
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.