BS EN ISO 23500-4:2019 Preparation and quality management of fluids for haemodialysis and related therapies. Concentrates for haemodialysis and related therapies

BS EN ISO 23500-4:2019

Preparation and quality management of fluids for haemodialysis and related therapies. Concentrates for haemodialysis and related therapies

Status : Current   Published : March 2019

Format
PDF

Format
HARDCOPY



What is this standard about?

This document specifies minimum requirements for concentrates used for haemodialysis and related therapies.

This document is addressed to the manufacturer of such concentrates. In several instances in this document, the dialysis fluid is addressed, 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.

This document includes concentrates in both liquid and powder forms. It also includes additives, also called spikes, which are chemicals that can be added to the concentrate to supplement or increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid.

This document also specifies requirements for equipment used to mix acid and bicarbonate powders into concentrate at the user's facility.

Concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility are excluded from the scope of this document. Although references to dialysis fluid appear herein, this document does not address dialysis fluid as made by the end user. This document also excludes requirements for the surveillance frequency of water purity used for the making of dialysis fluid by the dialysis facility. This document does not address bags of sterile dialysis fluid or sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid.

This document does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid is covered in ISO 23500-5. The making of dialysis fluid involves the proportioning of concentrate and water at the bedside or in a central dialysis fluid delivery system. Although the label requirements for dialysis fluid are placed on the labelling of the concentrate, it is the user's responsibility to ensure proper use.

This document does not cover haemodialysis equipment, which is addressed in IEC 60601-2-16:2012.




Standard NumberBS EN ISO 23500-4:2019
TitlePreparation and quality management of fluids for haemodialysis and related therapies. Concentrates for haemodialysis and related therapies
StatusCurrent
Publication Date27 March 2019
Normative References(Required to achieve compliance to this standard)IEC 60601-1, ISO 23500-3, ISO 23500-1, ISO 23500-5, IEC 61010-1
Informative References(Provided for Information)IEC 60601-2-16:2012, ISO 15223-1:2016, ISO 15223-2:2010, ISO 14971:2007
ReplacesBS EN ISO 13958:2015
International RelationshipsEN ISO 23500-4:2019,ISO 23500-4:2019
Draft Superseded By17/30321202 DC
DescriptorsMedical equipment, Water, Bacteria, Microbiology, Contamination, Purity, Chemical composition, Quality, Impurities, Artificial kidneys, Dialysis, Blood, Solutes
ICS11.040.40
11.120.99
Title in FrenchPréparation et management de la qualité des liquides d'hémodialyse et de thérapies annexes Concentrés pour hémodialyse et thérapies apparentées
Title in GermanLeitfaden für die Vorbereitung und das Qualitätsmanagement von Konzentraten für die Hämodialyse und verwandte Therapien Konzentrate für die Hämodialyse und verwandte Therapien
CommitteeCH/150/2
ISBN978 0 580 89754 2
PublisherBSI
FormatA4
DeliveryYes
Pages32
File Size1.957 MB
Price£182.00


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