BS EN ISO 23500-1:2019 Preparation and quality management of fluids for haemodialysis and related therapies. General requirements

BS EN ISO 23500-1:2019

Preparation and quality management of fluids for haemodialysis and related therapies. General requirements

Status : Current   Published : March 2019

Format
PDF

Format
HARDCOPY



What is this standard about?

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.




Standard NumberBS EN ISO 23500-1:2019
TitlePreparation and quality management of fluids for haemodialysis and related therapies. General requirements
StatusCurrent
Publication Date27 March 2019
Normative References(Required to achieve compliance to this standard)ISO 23500-4, ISO 23500-5, ISO 23500-3
Informative References(Provided for Information)IEC/TR 62653:2013, IEC 60601-1:2012, IEC 60601-1-11:2015, ASTM D4516 - 00(2010), ISO 23500-2:2019, IEC 60529:1989 Cons Ed 2-1, ISO 15883-1:2006, IEC 60529:1989/AMD1:1999, IEC 60601-2-16:2012
ReplacesBS EN ISO 23500:2015
International RelationshipsEN ISO 23500-1:2019,ISO 23500-1:2019
Draft Superseded By17/30321193 DC
DescriptorsContamination, Fluids, Microbiology, Chemical composition, Artificial kidneys, Water purification, Blood, Purity, Solutes, Water, Impurities, Dialysis, Quality control, Concentrates, Quality management, Medical equipment
ICS11.040.20
11.040.40
Title in FrenchPréparation et management de la qualité des liquides d'hémodialyse et de thérapies annexes Exigences générales
Title in GermanLeitfaden für die Vorbereitung und das Qualitätsmanagement von Konzentraten für die Hämodialyse und verwandte Therapien Allgemeine Anforderungen
CommitteeCH/150/2
ISBN978 0 580 89751 1
PublisherBSI
FormatA4
DeliveryYes
Pages96
File Size1.871 MB
Price£274.00


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