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.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 1<\/td>\n | ANSI\/AAMI 13958:2014, Concentrates for hemodialysis and related therapies <\/td>\n<\/tr>\n | ||||||
| 3<\/td>\n | Title page <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | AAMI Standard Copyright information <\/td>\n<\/tr>\n | ||||||
| 5<\/td>\n | Contents <\/td>\n<\/tr>\n | ||||||
| 6<\/td>\n | Glossary of equivalent standards <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | US deviation to ISO 13958:2014 <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | 1 Scope 2 Normative references <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 4 Requirements 4.1 Concentrates 4.1.1 Physical state 4.1.2 Solute concentrations 4.1.2.1 Liquid solute concentrations <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 4.1.7 Chemical grade 4.1.8 Particulates 4.1.9 Additives \u2014 \u201cSpikes\u201d 4.1.10 Containers 4.1.11 Bulk-delivered concentrate 4.1.12 Concentrate generators <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 4.3.5 Bulk storage tanks 4.3.6 Ultraviolet irradiators 4.3.7 Piping systems 4.3.8 Electrical safety requirements <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | Table 1 \u2014 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 <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 5.2.6 Fill quantity 5.2.7 Chemical grade 5.2.8 Particulates 5.2.9 Additives \u2014 \u201cSpikes\u201d 5.2.10 Containers 5.2.11 Bulk delivered concentrate 5.2.12 Concentrate generators 5.3 Manufacturing equipment <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 5.4.8 Electrical safety requirements 6 Labelling 6.1 General 6.2 General labelling requirements for concentrates <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 6.3 Labelling requirements for liquid concentrate <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 6.4 Labelling requirements for powder concentrate 6.5 Additives 6.6 Labelling requirements for concentrate generators <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | Table 2 \u2014 Symbols for concentrate container system: concentrate types 6.7 Labelling for concentrate mixer systems <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 6.7.2 Product literature for concentrate mixers <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | Annex A: Rationale for the development and provisions of this International Standard A.1 Scope <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | A.2 Requirements A.2.1 General A.2.1.1 Overview A.2.1.2 Physical state A.2.1.3 Solute concentrations <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | 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 \u2014 \u201cSpikes\u201d A.2.1.9 Containers <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | A.2.1.10 Endotoxin levels A.2.1.11 Bulk delivery concentrate A.2.1.12 Concentrate generator systems <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" ANSI\/AAMI 13958:2014 – Concentrates for hemodialysis and related therapies<\/b><\/p>\n |