BS EN ISO 23500-1:2024
$215.11
Preparation and quality management of fluids for haemodialysis and related therapies – General requirements
| Published By | Publication Date | Number of Pages |
| BSI | 2024 | 116 |
This document specifies the general requirements for the preparation of fluids for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration, for dialysis practitioners. This document gives guidance on the user’s responsibility for fluids used in haemodialysis and related therapies once the equipment used in its preparation has been delivered and installed. As dialysis water used to prepare dialysis fluid can also be used to reprocess dialysers not marked intended for single use, this aspect of water use is also covered by this document. This document is applicable to — the quality management of equipment used to treat and distribute water used for the preparation of dialysis fluid and substitution fluid, from the point at which municipal water enters the dialysis facility to the point at which the final dialysis fluid enters the dialyser or the point at which substitution fluid is infused. — the quality management of the equipment used to prepare acid and bicarbonate concentrate from powdered or other highly concentrated media at a dialysis facility, and — the preparation of the final dialysis fluid or substitution fluid from dialysis water and concentrates. This document does not apply to — sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, — systems for continuous renal replacement therapy that use pre-packaged solutions, and — systems and solutions for peritoneal dialysis. This document does not address clinical issues associated with inappropriate usage of such fluids.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 7 | Foreword |
| 9 | Introduction |
| 11 | 1 Scope 2 Normative references |
| 12 | 3 Terms and definitions |
| 19 | 4 Quality requirements 4.1 General |
| 20 | 4.2 Dialysis water 4.2.1 General 4.2.2 Chemical contaminants in dialysis water |
| 22 | 4.2.3 Organic carbon, pesticides and other chemicals 4.2.4 Microbiological contaminants in dialysis water 4.3 Requirements for concentrate 4.3.1 Chemical and microbiological contaminants in concentrate |
| 23 | 4.3.2 Water used to prepare concentrate 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 |
| 24 | 4.4.4 Microbiological requirements for online-prepared substitution fluid 4.5 Record retention 5 System design and technical considerations 5.1 General |
| 25 | 5.2 Technical aspects |
| 26 | 5.3 Microbiological aspects 5.4 Environmental impact 6 Validation of system performance 6.1 General |
| 28 | 6.2 Validation plan 6.3 Installation and operational qualification 6.4 Performance qualification |
| 29 | 6.5 Validation 6.5.1 General 6.5.2 Initial validation 6.5.3 Retrospective (annual) validation 6.5.4 Revalidation |
| 30 | 6.6 Monitoring and surveillance 7 Quality management 7.1 General |
| 31 | 7.2 Surveillance of fluid quality 7.2.1 Surveillance of dialysis water quality 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 |
| 32 | 7.3.3 Surveillance of cartridge filters 7.3.4 Surveillance of softeners |
| 33 | 7.3.5 Surveillance of carbon media 7.3.6 Surveillance of chemical injection systems |
| 34 | 7.3.7 Surveillance of reverse osmosis |
| 35 | 7.3.8 Surveillance of deionization 7.3.9 Surveillance of bacteria and endotoxin-retentive filters 7.3.10 Surveillance of dialysis water storage and distribution |
| 36 | 7.3.11 Surveillance of bacterial control devices |
| 37 | 7.4 Surveillance of concentrate preparation 7.4.1 Surveillance of mixing systems 7.4.2 Surveillance of additives 7.5 Surveillance of concentrate distribution 7.6 Surveillance of dialysis fluid proportioning |
| 38 | 8 Strategies for microbiological control 8.1 General 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 |
| 41 | 8.3.2 Sample collection |
| 42 | 8.3.3 Heterotrophic plate count |
| 44 | 8.3.4 Bacterial endotoxin test 8.3.5 Determination of yeast and mould |
| 45 | 9 Location of and access to the water treatment system 10 Personnel |
| 46 | Annex A (informative) Rationale for the development and provisions of this document |
| 52 | Annex B (informative) Equipment |
| 71 | Annex C (informative) Surveillance guidelines for water treatment equipment, distribution systems and dialysis fluid |
| 75 | Annex D (informative) Strategies for microbiological control |
| 85 | Annex E (informative) Validation |
| 93 | Annex F (informative) Special considerations for home haemodialysis |
| 100 | Annex G (informative) Special considerations for acute haemodialysis |
| 105 | Annex H (informative) Further considerations for different water quality monitoring approaches |
| 107 | Annex I (informative) Additional considerations for risk assessment |
| 110 | Bibliography |
