DIN EN ISO 13958:2016-03

The text of ISO 13958:2014 has been prepared by Technical Committee ISO/TC 150 "Implants for surgery" of the International Organization for Standardization (ISO) and adopted as EN ISO 13958:2015 by Technical Committee CEN/TC 205 "Non-active medical devices", the secretariat of which is held by DIN (Germany). The responsible German committee is Working Committee NA 063-01-03 AA "Extrakorporaler Kreislauf, Apparate und Einmalartikel" ("Extracorporeal circuits, equipment and disposables") at DIN Standards Committee Medicine (NAMed). This document specifies minimum requirements for concentrates used for haemodialysis and related therapies. For the purpose of this International Standard, “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. This document is addressed to the manufacturer of such concentrates. In several instances in this document, it became necessary to address the dialysis fluid, which is made by the end user, to help clarify the requirements for manufacturing concentrates. Because the manufacturer of the concentrate does not have control over the final dialysis fluid, any reference to dialysis fluid is for clarification and is not a requirement of the manufacturer.