BS EN ISO 23500-2:2024

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Preparation and quality management of fluids for haemodialysis and related therapies – Water treatment equipment for haemodialysis applications and related therapies

Published By	Publication Date	Number of Pages
BSI	2024	42

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Categories: 11.040.40 - Implants for surgery, prosthetics and orthotics, BSI

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Description

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PDF Pages	PDF Title
2	undefined
4	European foreword Endorsement notice
7	Foreword
8	Introduction
9	1 Scope 2 Normative references
10	3 Terms and definitions 4 Requirements 4.1 Dialysis water quality requirements 4.1.1 General 4.1.2 Chemical contaminant requirements
11	4.1.3 Organic carbon, pesticides and other chemicals 4.1.4 Microbiology of dialysis water 4.2 Water treatment equipment requirements 4.2.1 General
13	4.2.2 Backflow prevention 4.2.3 Tempering valves 4.2.4 Sediment filters 4.2.5 Cartridge filters 4.2.6 Softeners 4.2.7 Anion exchange resin tank 4.2.8 Carbon media
15	4.2.9 Chemical injection systems 4.2.10 Reverse osmosis
16	4.2.11 Deionization 4.2.12 Bacteria and endotoxin retentive filters 4.2.13 Storage and distribution of dialysis water
18	4.3 Electrical safety of water treatment equipment for haemodialysis applications and related therapies 5 Testing 5.1 Conformity with dialysis water quality requirements 5.1.1 General
19	5.1.2 Microbiology of dialysis water
20	5.1.3 Maximum level of chemical contaminants 5.2 Conformity with water treatment equipment requirements 5.2.1 General
21	5.2.2 Backflow prevention 5.2.3 Tempering valves 5.2.4 Sediment filters 5.2.5 Cartridge filters 5.2.6 Softeners 5.2.7 Anion exchange resin tanks
22	5.2.8 Carbon media 5.2.9 Chemical injection systems 5.2.10 Reverse osmosis 5.2.11 Deionization 5.2.12 Endotoxin retentive filters 5.2.13 Storage and distribution of dialysis water
23	6 Labelling 6.1 General 6.2 Device or system markings 6.3 Product literature
26	Annex A (informative) Rationale for the development and provisions of this document
37	Annex B (informative) Reference tables
39	Bibliography

Additional information

Status	Definitive
Pages	42
Publication Date	2024-07-31
ISBN	978 0 539 20658 6
Standard Number	BS EN ISO 23500-2:2024
Title	Preparation and quality management of fluids for haemodialysis and related therapies – Water treatment equipment for haemodialysis applications and related therapies
Identical National Standard Of	EN ISO 23500-2, ISO 23500-2:2024
Replaces	BS EN ISO 23500-2:2019
Descriptors	Filtration, Solutes, Reverse osmosis, Chemical technology equipment, Biological filters, Contamination, Artificial kidneys, Water purification, Dialysis, Water, Performance testing, Medical equipment, Water treatment
Publisher	BSI
Committee	CH/150/2
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics

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BS EN ISO 23500-2:2024

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