AAMI RD61 : 2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Hardcopy , PDF
03-22-2011
English
01-01-2006
Glossary of equivalent standards
Committee representation
Foreword
1 Scope
1.1 General
1.2 Inclusions
1.3 Exclusions
2 Normative references
3 Definitions and abbreviations
4 Requirements
4.1 General
4.1.1 Physical state
4.1.2 Solute concentrations
4.1.3 Water contaminants
4.1.4 MIcrobiology of bicarbonate concentrates
4.1.5 Fill volume
4.1.6 Chemical grade
4.1.7 Particulates
4.1.8 Additives
4.1.9 Containers
4.1.10 Endotoxin levels
4.1.11 Bulk delivered concentrate
4.1.12 Concentrate generators
4.2 Manufacturing equipment
4.3 Systems for mixing concentrate at a dialysis facility
5 Tests
5.1 General
5.1.1 Physical state
5.1.2 Solute concentration
5.1.3 Water contaminants
5.1.4 Microbiology of bicarbonate concentrates
5.1.5 Fill volume
5.1.6 Chemical grade
5.1.7 Particulates
5.1.8 Additives
5.1.9 Containers
5.1.10 Endotoxin levels
5.1.11 Bulk delivered concentrate
5.1.12 Concentrate generators
5.2 Manufacturing equipment
5.3 Systems for mixing concentrate at a dialysis facility
6 Labeling
6.1 General
6.1.1 General labeling requirements for concentrates
6.1.2 Labeling requirements for liquid concentrate
6.1.3 Labeling requirements for powder concentrate
6.1.4 Concentrate generators
6.2 Labeling for systems for mixing concentrate at a
dialysis facility
Annex A - Rationale for the development and provisions of this
standard
Bibliography
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