AAMI 26722 2014
$115.49
ANSI/AAMI 26722:2014 – Water treatment equipment for hemodialysis and related therapies
Published By | Publication Date | Number of Pages |
AAMI | 2014 | 46 |
Covers devices used to treat water intended for use in the delivery of hemodialysis and related therapies, including water used for: (1) the preparation of concentrates from powder or other highly concentrated media at a dialysis facility; (2) the preparation of dialysis fluid, including dialysis fluid that can be used for the preparation of substitution fluid; (3) the reprocessing of dialyzers for multiple uses. Included within the scope are all devices, piping and fittings between the point at which potable water is delivered to the water treatment system, and the point of use of the dialysis water. Addressed to the manufacturer and/or supplier of water treatment systems and/or devices used for the express purpose of providing water for hemodialysis or related therapies.
PDF Catalog
PDF Pages | PDF Title |
---|---|
1 | ANSI/AAMI 26722:2014, Water treatment equipment for hemodialysis and related therapies |
3 | Title page |
4 | AAMI Standard Copyright information |
5 | Contents |
6 | Glossary of equivalent standards |
7 | Committee representation |
8 | US deviation to ISO 26722:2014 |
9 | Introduction |
11 | 1 Scope 1.1 General 1.2 Inclusions 1.3 Exclusions 2 Normative references |
12 | 3 Terms and definitions |
17 | 4 Requirements 4.1 Dialysis water quality requirements 4.1.1 General 4.1.2 Microbiology of dialysis water |
18 | 4.1.3 Maximum level of chemical contaminants 4.2 Water treatment equipment requirements 4.2.1 General 4.2.1.1 Water treatment system |
19 | 4.2.1.2 Materials compatibility 4.2.1.3 Regenerated or reconstituted devices 4.2.1.4 Disinfection protection 4.2.2 Backflow prevention device 4.2.3 Tempering valves 4.2.4 Sediment filters |
20 | 4.2.5 Cartridge filters 4.2.6 Softeners 4.2.7 Anion exchange resin tank 4.2.8 Carbon media |
21 | 4.2.9 Chemical injection systems 4.2.10 Reverse osmosis |
22 | 4.2.11 Deionization 4.2.12 Endotoxin-retentive filters 4.2.13 Storage and distribution of dialysis water 4.2.13.1 Piping systems |
23 | 4.2.13.2 Storage tanks 4.2.13.3 Ultraviolet irradiators 4.2.13.4 Hot water disinfection systems |
24 | 4.2.13.5 Ozone disinfection systems 5 Tests 5.1 Compliance with dialysis water quality requirements 5.1.1 General 5.1.2 Microbiology of dialysis water |
25 | 5.1.3 Maximum level of chemical contaminants 5.2 Compliance with water treatment equipment requirements 5.2.1 General 5.2.1.1 Water treatment system 5.2.1.2 Materials compatibility |
26 | 5.2.1.3 Regenerated or reconstituted devices 5.2.1.4 Disinfection protection 5.2.2 Backflow prevention devices 5.2.3 Tempering valves 5.2.4 Sediment filters 5.2.5 Cartridge filters 5.2.6 Softeners |
27 | 5.2.7 Anion exchange resin tanks 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 |
28 | 5.2.13 Storage and distribution of dialysis water 5.2.13.1 Piping systems 5.2.13.2 Storage tanks 5.2.13.3 Ultraviolet irradiators 5.2.13.4 Hot water disinfection systems 5.2.13.5 Ozone disinfection systems 6 Labelling 6.1 General 6.2 Device markings |
29 | 6.3 Product literature |
31 | Annex A: Rationale for the development and provisions of this International Standard A.1 Scope A.2 Requirements A.2.1 Dialysis water quality requirements A.2.1.1 General A.2.1.2 Microbiology of dialysis water |
32 | A.2.1.3 Maximum level of chemical contaminants A.2.2 Water treatment equipment requirements A.2.2.1 General A.2.2.1.1 Water treatment system |
33 | A.2.2.1.2 Materials compatibility A.2.2.1.3 Regenerated or reconstituted devices A.2.2.1.4 Disinfection protection A.2.2.2 Backflow prevention device A.2.2.3 Tempering valves |
34 | A.2.2.4 Sediment filters A.2.2.5 Cartridge filters A.2.2.6 Softeners A.2.2.7 Anion exchange resin tank A.2.2.8 Carbon media |
35 | A.2.2.9 Chemical injection systems |
36 | A.2.2.10 Reverse osmosis |
37 | A.2.2.11 Deionization A.2.2.12 Endotoxin-retentive filters |
38 | A.2.2.13 Storage and distribution A.2.2.13.1 Piping systems A.2.2.13.2 Storage tanks A.2.2.13.3 Ultraviolet irradiators |
39 | A.2.2.13.4 Hot water disinfection systems A.2.2.13.5 Ozone disinfection systems A.3 Tests A.3.1 Compliance with dialysis water quality requirements — Microbiology of dialysis water A.3.2 Compliance with water treatment equipment requirements — Materials compatibility |
40 | A.4 Labelling |
41 | Annex B: Reference tables from ISO 13959 Table B.1 — Maximum allowable levels of toxic chemicals and dialysis fluid electrolytes in dialysis water Table B.2 — Maximum allowable levels of other trace elements in dialysis water |
42 | Table B.3 — Analytical test methods for chemical contaminants |
45 | Bibliography |