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BSI 22/30449644 DC 2022

BSI 22/30449644 DC 2022

$24.66

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

Published By Publication Date Number of Pages
BSI 2022 113
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PDF Catalog

PDF Pages PDF Title
7 Foreword
8 Introduction
9 1 Scope
1.1 General
1.2 Inclusions
10 1.3 Exclusions
2 Normative references
3 Terms and definitions
18 4 Quality requirements
4.1 General
4.2 Dialysis water
4.2.1 General
4.2.2 Chemical contaminants in dialysis water
20 4.2.3 Organic Carbon, pesticides and other chemicals
21 4.2.4 Microbiological contaminants in dialysis water
4.3 Requirements for concentrate
4.3.1 Chemical and microbiological contaminants in concentrate
4.3.2 Water used to prepare concentrate
22 4.4 Requirements for dialysis fluid
4.4.1 General
4.4.2 Microbiological requirements for standard dialysis fluid
4.4.3 Microbiological requirements for ultrapure dialysis fluid
23 4.4.4 Microbiological requirements for online-prepared substitution fluid
4.5 Record retention
5 System design and technical considerations
5.1 General
24 5.2 Technical aspects
25 5.3 Microbiological aspects
5.4 Environmental impact
26 6 Validation of system performance
6.1 General
27 6.2 Validation plan
6.3 Installation and operational qualification
28 6.4 Performance qualification
29 6.5 Validation
6.5.1 Initial Validation.
6.5.2 Retrospective [Annual] Validation
6.5.3 Revalidation
6.6 Surveillance
30 7 Quality management
7.1 General
7.2 Surveillance of fluid quality
7.2.1 Surveillance of dialysis water quality
31 7.2.2 Surveillance of concentrate quality
7.2.3 Surveillance of dialysis fluid quality
7.3 Surveillance of water treatment equipment
7.3.1 General
7.3.2 Surveillance of sediment filters
7.3.3 Surveillance of cartridge filters
32 7.3.4 Surveillance of softeners
7.3.5 Surveillance of carbon media
33 7.3.6 Surveillance of chemical injection systems
7.3.7 Surveillance of reverse osmosis
34 7.3.8 Surveillance of deionization
35 7.3.9 Surveillance of endotoxin-retentive filters
7.3.10 Surveillance of water storage tanks
7.3.11 Surveillance of the water distribution systems
7.3.12 Surveillance of bacterial control devices
36 7.4 Surveillance of concentrate preparation
7.4.1 Surveillance of mixing systems
7.4.2 Surveillance of additives
37 7.5 Surveillance of concentrate distribution
7.6 Surveillance of dialysis fluid proportioning
8 Strategies for microbiological control
8.1 General
38 8.2 Disinfection
8.2.1 General
8.2.2 Microbiological aspects of fluid system design
39 8.2.3 Disinfection frequency
40 8.3 Microbiological surveillance methods
8.3.1 General
8.3.2 Sample collection
41 8.3.3 Heterotrophic plate count
43 8.3.4 Bacterial endotoxin test
8.3.5 Determination of yeast and mould
44 9 Location of and access to the water treatment system
10 Personnel
45 Annex€A (informative) Rationale for the development and provisions of this document
51 Annex€B (informative) Equipment
71 Annex€C (informative) Surveillance guidelines for water treatment equipment, distribution€systems, and dialysis fluid
76 Annex€D (informative) Strategies for microbiological control
83 Annex€E (informative) Validation
90 Annex€F (informative) Special considerations for home haemodialysis
97 Annex€G (informative) Special considerations for acute haemodialysis
102 Annex€H (informative) Further considerations for the different water quality monitoring approaches
104 Annex€I (informative) Further considerations for risk assessment
107 Bibliography

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BSI 22/30449644 DC 2022
$24.66