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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 040 Date of Entry 08/14/2015 
FR Recognition Number 9-97
ISO 13958 Third edition 2014-04-01
Concentrates for haemodialysis and related therapies
U.S. Identical Adoption
ANSI AAMI ISO 13958:2014
Concentrates for hemodialysis and related therapies
ISO 13958:2014 specifies minimum requirements for concentrates used for haemodialysis and related therapies. For the purpose of ISO 13958:2014, "concentrates" are a mixture of chemicals and water, or chemicals in the form of dry powder or other highly concentrated media, that are delivered to the end user to make dialysis fluid used to perform haemodialysis and related therapies. ISO 13958:2014 is addressed to the manufacturer of such concentrates.

ISO 13958:2014 includes concentrates in both liquid and powder forms. Also included are additives, also called spikes, which are chemicals that may be added to the concentrate to increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid. ISO 13958:2014 also gives requirements for equipment used to mix acid and bicarbonate powders into concentrate at the user's facility.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Section 3.28; Section 5.2.10; and Section 5.4.2.
Transition Period
FDA recognition of ISO 13958 Third edition 2014-04-01 [Rec# 9-97] will be superseded by recognition of ISO 23500-4 First edition 2019 [Rec# 9-136]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 9-97] until July 10, 2022. After this transition period, declarations of conformity to [Rec# 9-97] will not be accepted
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) Class 2 KPO
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.
FDA Technical Contact
 Frank Hurst
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.