| ISO 13958 Third edition 2014-04-01 Concentrates for haemodialysis and related therapies |
| Recognition Date | 2015-08-14 |
| Recognition List | 040 |
| Recognition Number | 9-97 |
| Extent | 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. |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | ObGyn/Gastroenterology/Urology |
| FDA Tech | Frank Hurst FDA/OMPT/CDRH/ODE/DRGUD/RNDB/ 301-796-5968 frank.hurst@fda.hhs.gov |
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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.
| Regulation Number | Device Name | Device Class | Product Code |
| §876.5820 | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | Class 2 | KPO |
| 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. |