AAMI 13958 2014

$93.55

ANSI/AAMI 13958:2014 – Concentrates for hemodialysis and related therapies

Published By	Publication Date	Number of Pages
AAMI	2014	37

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Description

Specifies minimum requirements for concentrates used for hemodialysis and related therapies. Addressed to the manufacturer of concentrates. Includes concentrates in both liquid and powder forms. Also included are additives, also called spikes, which are chemicals that may be added to the concentrate to increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid. Gives requirements for equipment used to mix acid and bicarbonate powders into concentrate at the user’s facility.

PDF Catalog

PDF Pages	PDF Title
1	ANSI/AAMI 13958:2014, Concentrates 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 13958:2014
9	Introduction
11	1 Scope 2 Normative references
12	3 Terms and definitions
17	4 Requirements 4.1 Concentrates 4.1.1 Physical state 4.1.2 Solute concentrations 4.1.2.1 Liquid solute concentrations
18	4.1.2.2 Solute concentrations from powder 4.1.3 Water 4.1.4 Bacteriology of concentrates 4.1.4.1 Bacteriology of bicarbonate concentrates 4.1.4.2 Bacteriology of acid concentrates 4.1.5 Endotoxin levels 4.1.6 Fill quantity
19	4.1.7 Chemical grade 4.1.8 Particulates 4.1.9 Additives — “Spikes” 4.1.10 Containers 4.1.11 Bulk-delivered concentrate 4.1.12 Concentrate generators
20	4.2 Manufacturing equipment 4.3 Systems for mixing concentrate at a dialysis facility 4.3.1 General 4.3.2 Materials compatibility 4.3.3 Disinfection protection 4.3.3.1 General 4.3.3.2 System lock out 4.3.4 Safety requirements
21	4.3.5 Bulk storage tanks 4.3.6 Ultraviolet irradiators 4.3.7 Piping systems 4.3.8 Electrical safety requirements
22	5 Tests 5.1 General 5.2 Concentrates 5.2.1 Physical state 5.2.2 Solute concentrations 5.2.2.1 Liquid solute concentrations
23	Table 1 — Analytical tests for chemical components 5.2.2.2 Solute concentrations from powder 5.2.3 Water 5.2.4 Bacteriology of bicarbonate concentrates 5.2.5 Endotoxin levels
24	5.2.6 Fill quantity 5.2.7 Chemical grade 5.2.8 Particulates 5.2.9 Additives — “Spikes” 5.2.10 Containers 5.2.11 Bulk delivered concentrate 5.2.12 Concentrate generators 5.3 Manufacturing equipment
25	5.4 Systems for mixing concentrate at a dialysis facility 5.4.1 General 5.4.2 Materials compatibility 5.4.3 Disinfection protection 5.4.3.1 General 5.4.3.2 System lock out 5.4.4 Safety requirements 5.4.5 Bulk storage tanks 5.4.6 Ultraviolet irradiators 5.4.7 Piping systems
26	5.4.8 Electrical safety requirements 6 Labelling 6.1 General 6.2 General labelling requirements for concentrates
27	6.3 Labelling requirements for liquid concentrate
28	6.4 Labelling requirements for powder concentrate 6.5 Additives 6.6 Labelling requirements for concentrate generators
29	Table 2 — Symbols for concentrate container system: concentrate types 6.7 Labelling for concentrate mixer systems
30	6.7.2 Product literature for concentrate mixers
31	Annex A: Rationale for the development and provisions of this International Standard A.1 Scope
32	A.2 Requirements A.2.1 General A.2.1.1 Overview A.2.1.2 Physical state A.2.1.3 Solute concentrations
33	A.2.1.4 Water A.2.1.5 Bacteriology of bicarbonate concentrates A.2.1.6 Fill quantity A.2.1.7 Chemical grade A.2.1.8 Additives — “Spikes” A.2.1.9 Containers
34	A.2.1.10 Endotoxin levels A.2.1.11 Bulk delivery concentrate A.2.1.12 Concentrate generator systems
35	A.2.2 Manufacturing equipment A.2.2.1 General A.2.2.2 Endotoxin levels A.3 Labelling A.3.1 General A.3.2 Labelling requirements for liquid concentrate A.3.3 Labelling requirements for powder concentrate
37	Bibliography