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AAMI RD61 : 2006

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by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

Available format(s)

Hardcopy , PDF

Superseded date

22-03-2011

Superseded by

AAMI ISO 13958 : 2009

Language(s)

English

Published date

01-01-2006

€73.58
Excluding VAT

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Superseded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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