AAMI 23500 2014
$162.84
ANSI/AAMI 23500:2014 – Guidance for the preparation and quality management of fluids for hemodialysis and related therapies.
| Published By | Publication Date | Number of Pages |
| AAMI | 2014 | 100 |
Addresses the user’s responsibility for the dialysis fluid once the equipment used in its preparation has been delivered and installed. Includes dialysis water used for the preparation of dialysis fluid and substitution fluid, dialysis water used for the preparation of concentrates at the user’s facility, as well as concentrates and the final dialysis fluid and substitution fluid.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI 23500:2014, Guidance for the preparation and quality management of fluids for hemodialysis and related therapies |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 7 | Glossary of equivalent standards |
| 8 | Committee representation |
| 9 | US deviation to ISO 23500:2014 |
| 10 | Introduction |
| 12 | 1 Scope 1.1 General 1.2 Inclusions 1.3 Exclusions 2 Normative references |
| 13 | 3 Terms and definitions |
| 20 | 4 Summary of quality requirements of ISO 13958, ISO 13959 and ISO 11663 |
| 21 | 4.1 Dialysis water 4.1.1 General 4.1.2 Chemical contaminants in dialysis water Table 1 — Maximum allowable levels of toxic chemicals and dialysis fluid electrolytes in dialysis waterab |
| 22 | Table 2 — Maximum allowable levels of other trace elements in dialysis watera 4.1.3 Microbiological contaminants in dialysis water |
| 23 | Table 3 — Maximum allowable levels for total viable microbial count (TVC) and endotoxins in dialysis watera 4.2 Requirements for concentrate 4.2.1 Chemical and microbiological contaminants in concentrate 4.2.2 Water used to prepare concentrate 4.3 Requirements for dialysis fluid 4.3.1 General 4.3.2 Microbiological requirements for standard dialysis fluid |
| 24 | Table 4 — Maximum allowable levels for total viable microbial count (TVC) and endotoxins in standard and ultrapure dialysis fluida 4.3.4 Microbiological requirements for online-prepared substitution fluid 4.3.3 Microbiological requirements for ultrapure dialysis fluid 4.4 Record retention 5 Critical aspects of system design |
| 25 | 5.1 Technical aspects 5.2 Microbiological aspects |
| 26 | 6 Validation of system performance 6.1 Validation plan |
| 27 | Figure 1—Example of a validation process for a fluid preparation and distribution system 6.2 Installation and operational qualification |
| 28 | 6.3 Performance qualification 6.4 Routine monitoring and revalidation |
| 29 | 7 Quality management 7.1 General 7.2 Monitoring of fluid quality 7.2.1 Monitoring of dialysis water quality |
| 30 | 7.2.2 Monitoring of concentrate quality 7.2.3 Monitoring of dialysis fluid quality 7.3 Monitoring of water treatment equipment 7.3.1 General 7.3.2 Monitoring of sediment filters |
| 31 | 7.3.3 Monitoring of cartridge filters 7.3.4 Monitoring of softeners 7.3.5 Monitoring of carbon media |
| 32 | 7.3.6 Monitoring of chemical injection systems 7.3.7 Monitoring of reverse osmosis |
| 33 | 7.3.8 Monitoring of deionization |
| 34 | 7.3.9 Monitoring of endotoxin-retentive filters 7.4 Monitoring of dialysis water storage and distribution 7.4.1 Monitoring of water storage tanks 7.4.2 Monitoring of the water distribution systems |
| 35 | 7.4.3 Monitoring of bacterial control devices 7.4.3.1 Monitoring of ultraviolet irradiators 7.4.3.2 Monitoring of ozone generators 7.4.3.3 Monitoring of hot water disinfection systems 7.5 Monitoring of concentrate preparation 7.5.1 Monitoring of mixing systems 7.5.2 Monitoring of additives |
| 36 | 7.6 Monitoring of concentrate distribution 7.7 Monitoring of dialysis fluid proportioning 8 Strategies for microbiological control 8.1 General |
| 37 | 8.2 Disinfection 8.2.1 Microbiological aspects of fluid system design |
| 38 | 8.2.2 Disinfection frequency 8.2.2.1 General 8.2.2.2 Dialysis water storage and distribution systems 8.2.2.3 Concentrate mixing systems 8.2.2.4 Concentrate distribution systems |
| 39 | 8.3 Microbiological monitoring methods 8.3.1 General 8.3.2 Sample collection 8.3.2.1 Dialysis water sample sites |
| 40 | 8.3.2.2 Dialysis fluid samples 8.3.3 Heterotrophic plate count 8.3.3.1 Storage of samples 8.3.3.2 Analytical methods 8.3.3.2.1 Membrane filtration 8.3.3.2.2 Spread-plate technique 8.3.3.2.3 Pour-plate technique |
| 41 | 8.3.3.2.4 Dip samplers 8.3.3.3 Cultivation conditions Table 5 — Cultivation techniques 8.3.4 Bacterial endotoxin test |
| 42 | 9 Environment 10 Personnel |
| 43 | Annex A: Rationale for the development and provisions of this International Standard A.1 Scope A.2 Chemical contaminants in dialysis water A.3 Microbiological contaminants in dialysis water A.4 Requirements for concentrate |
| 44 | A.5 Microbiological contaminants in dialysis fluid A.6 Monitoring of carbon media A.7 Strategies for microbiological control |
| 45 | A.8 Heterotrophic plate count |
| 46 | A.9 Cultivation conditions A.10 Bacterial endotoxin test |
| 47 | Annex B: Equipment B.1 General B.2 Water treatment systems B.2.1 General |
| 48 | B.2.2 Sediment filters B.2.3 Cartridge filters B.2.4 Softeners |
| 49 | B.2.5 Carbon media |
| 50 | B.2.6 Chemical injection systems |
| 51 | B.2.7 Reverse osmosis |
| 52 | B.2.8 Deionization |
| 53 | B.2.9 Endotoxin-retentive filters B.3 Dialysis Water storage and distribution B.3.1 General |
| 54 | B.3.2 Water storage B.3.3 Water distribution |
| 55 | Table B.1 — Guidance on piping materials used in dialysis water distribution systems and their compatibility with common disinfectants B.3.4 Bacterial control devices B.3.4.1 General |
| 56 | B.3.4.2 Ultraviolet irradiators B.3.4.3 Ozone disinfection systems B.3.4.4 Hot water disinfection systems |
| 57 | B.4 Concentrate preparation B.4.1 General |
| 58 | B.4.2 Materials compatibility B.4.3 Labelling B.4.3.1 General B.4.3.2 Mixing tanks B.4.3.3 Bulk storage/dispensing tanks B.4.3.4 Concentrate containers |
| 59 | B.4.4 Concentrate mixing systems B.4.4.1 General B.4.4.2 Acid concentrate mixing systems B.4.4.3 Bicarbonate concentrate mixing systems |
| 60 | B.4.5 Additives B.5 Concentrate storage and distribution B.5.1 Materials compatibility B.5.2 Bulk storage tanks (acid concentrate) B.5.3 Distribution systems |
| 61 | B.5.3.1 Acid concentrate distribution systems B.5.3.2 Bicarbonate concentrate distribution systems |
| 62 | B.5.3.3 Concentrate outlets B.6 Dialysis fluid proportioning |
| 63 | Table B.2 — Symbols and colour coding for different concentrate proportioning ratios |
| 64 | B.7 Central dialysis fluid storage and delivery systems B.7.1 General B.7.2 Design and maintenance |
| 65 | B.7.3 Dialysis fluid storage B.7.4 Materials compatibility |
| 66 | Annex C: Monitoring guidelines for water treatment equipment, distribution systems, and dialysis fluid C.1 Monitoring systems Table C.1 — Suggested framework for monitoring water treatment equipment, distribution systems, and dialysis fluid |
| 71 | C.2 Cleaning/disinfection strategies Table C.2 — Summary of cleaning/disinfection strategies for dialysis water treatment systems, dialysis water storage and distribution systems, concentrate distribution systems, and dialysis fluid distribution systems |
| 73 | Annex D: Strategies for microbiological control D.1 General |
| 75 | D.2 Microbial monitoring methods D.2.1 General D.2.2 Sample collection |
| 76 | D.2.3 Heterotrophic plate count |
| 77 | D.2.4 Bacterial endotoxin test D.3 Interpreting the results of microbial monitoring |
| 78 | Annex E: Validation E.1 General and background E.2 Validation programme E.2.1 General E.2.2 Validation steps |
| 79 | E.2.3 Validation plan E.2.4 Performance qualification |
| 80 | E.3 Consequences for the monitoring strategy |
| 81 | Annex F: Special considerations for home hemodialysis F.1 General F.2 Fluid quality F.3 Utilities F.3.1 Water supply |
| 82 | F.3.2 Drain F.3.3 Electrical wiring and power supply |
| 83 | F.4 Environment F.5 Equipment F.5.1 General F.5.2 Softener |
| 84 | F.5.3 Carbon media F.5.4 Reverse osmosis F.5.5 Deionization F.5.6 Dialysis water distribution F.6 Concentrate F.6.1 Bicarbonate concentrate F.6.2 Acid concentrate |
| 85 | F.7 Monitoring F.7.1 Dialysis Water and dialysis fluid quality F.7.2 Equipment F.7.2.1 General F.7.2.2 Cartridge filter F.7.2.3 Softener |
| 86 | F.7.2.4 Carbon media F.7.2.5 Reverse osmosis |
| 87 | Annex G: Special considerations for acute hemodialysis G.1 General G.2 Fluid quality G.3 Equipment G.3.1 General |
| 88 | G.3.2 Backflow prevention G.3.3 Electrical safety G.3.4 Carbon media |
| 89 | G.3.5 Ion exchange G.3.5.1 Deionization G.3.5.2 Softeners |
| 90 | G.3.6 Reverse osmosis G.3.7 Endotoxin-retentive filters G.4 Microbial control strategies |
| 92 | Bibliography |
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