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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
CONCENTRATES FOR HEMODIALYSIS
Hardcopy , PDF
22-03-2011
English
01-01-2006
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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
Specifies manufacturing, labeling and testing requirements for concentrates to be diluted for use as dialyzing fluids in hemodialyzers.
| Committee |
WG 02
|
| DocumentType |
Standard
|
| Pages |
29
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy |
| AAMI RD52 : 2004 : R2010 | DIALYSATE FOR HEMODIALYSIS |
| AAMI RD52 : 2004 | DIALYSATE FOR HEMODIALYSIS |
| AAMI RD5 : 2003 | HEMODIALYSIS SYSTEMS |
| AAMI RD52 : 2004 : INC : AMD 1 : 2007 : AMD 2 : 2007 : AMD 3 : 2009 : AMD 4 : 2009 | DIALYSATE FOR HEMODIALYSIS |
| ISO 13958:2014 | Concentrates for haemodialysis and related therapies |
| AAMI RD62 : 2006 | WATER TREATMENT EQUIPMENT FOR HEMODIALYSIS APPLICATIONS |
| AAMI ISO 15223 : 2000 AMD 2 2004 | MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELING, AND INFORMATION TO BE SUPPLIED |
| IEC 60601-1-1:2000 | Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
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