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AAMI RD52 : 2004

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

DIALYSATE FOR HEMODIALYSIS

Superseded date

07-09-2021

Published date

01-01-2010

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Glossary of equivalent standards
Committee representation
Foreword
Introduction: Need for this AAMI recommended practice
Changes to ANSI/AAMI RD52:2004, as a result of Amendments
1 - 4
1 Scope
  1.1 General
  1.2 Inclusions
  1.3 Exclusions
2 Normative references
3 Definitions
4 Fluid quality
  4.1 Water
      4.1.1 Maximum level of chemical contaminants in water
      4.1.2 Bacteriology of water
  4.2 Concentrate
      4.2.1 Maximum level of chemical contaminants in
            concentrate
      4.2.2 Bacteriology of concentrate
  4.3 Dialysate
      4.3.1 Maximum level of chemical contaminants in
            dialysate
      4.3.2 Bacteriology of dialysate
5 Equipment
  5.1 General
  5.2 Water purification systems
      5.2.1 General
      5.2.2 Sediment filters
      5.2.3 Cartridge filters
      5.2.4 Softeners
      5.2.5 Carbon adsorption
      5.2.6 Chemical injection systems
      5.2.7 Reverse osmosis
      5.2.8 Deionization
      5.2.9 Ultrafiltration
  5.3 Water storage and distribution
      5.3.1 General
      5.3.2 Water storage
      5.3.3 Water distribution systems
      5.3.4 Bacterial control devices
  5.4 Concentrate preparation
      5.4.1 General
      5.4.2 Materials compatibility
      5.4.3 Bulk storage tanks (acid concentrate)
      5.4.4 Mixing systems
      5.4.5 Additives
  5.5 Concentrate distribution
      5.5.1 Materials compatibility
      5.5.2 System configurations
      5.5.3 Acid concentrate distribution systems
      5.5.4 Bicarbonate concentrate distribution systems
      5.5.5 Concentrate outlets
  5.6 Dialysate proportioning
6 Monitoring
  6.1 General
  6.2 Water purification
      6.2.1 General
      6.2.2 Sediment filters
      6.2.3 Cartridge filters
      6.2.4 Softeners
      6.2.5 Carbon adsorption
      6.2.6 Chemical injection systems
      6.2.7 Reverse osmosis
      6.2.8 Deionization
      6.2.9 Ultrafiltration
  6.3 Water storage and distribution
      6.3.1 General
      6.3.2 Water storage
      6.3.3 Water distribution systems
      6.3.4 Bacterial control devices
  6.4 Concentrate preparation
      6.4.1 Mixing systems
      6.4.2 Additives
  6.5 Concentrate distribution
  6.6 Dialysate proportioning
7 Strategies for bacterial control
  7.1 General
  7.2 Microbial monitoring methods
      7.2.1 General
      7.2.2 Sample collection
      7.2.3 Heterotrophic plate count
      7.2.4 Bacterial endotoxin test
8 Environment
9 Personnel
Annexes
A - Rationale for the development and provisions of this
    recommended practice
B - Bibliography
C - Special considerations for home hemodialysis
D - Self-assessment of compliance with recommendations
    for dialysate preparation
E - Special considerations for acute hemodialysis

Gives guidance to dialysis practitioners on the preparation of dialysate for hemodialysis and related therapies, from the point at which municipal water enters their dialysis facility to the point at which the final dialysate enters the dialyzer.

Committee
TG 05
DevelopmentNote
AMD 1, AMD 2, AMD 3 and AMD 4 are not available separately, incorporated in 2004 edition. (05/2009)
DocumentType
Standard
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy

I.S. EN ISO 11663:2015 QUALITY OF DIALYSIS FLUID FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 11663:2014)
AAMI TIR 43 : 2011 ULTRAPURE DIALYSATE FOR HEMODIALYSIS AND RELATED THERAPIES
CSA ISO 11663 : 2015 QUALITY OF DIALYSIS FLUID FOR HAEMODIALYSIS AND RELATED THERAPIES
BS ISO 11663 : 2014 QUALITY OF DIALYSIS FLUID FOR HAEMODIALYSIS AND RELATED THERAPIES
BS EN ISO 11663:2015 Quality of dialysis fluid for haemodialysis and related therapies
AAMI 11663 : 2014 QUALITY OF DIALYSIS FLUID FOR HEMODIALYSIS AND RELATED THERAPIES
AAMI TIR58 : 2014 WATER TESTING METHODOLOGIES
ISO 11663:2014 Quality of dialysis fluid for haemodialysis and related therapies
AAMI RD47 : 2008 REPROCESSING OF HEMODIALYZERS
UNE-EN ISO 11663:2016 Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014)
EN ISO 11663:2015 Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014)
AAMI TIR72 : 2017 DIALYSIS FLUID CHEMICAL COMPOSITION
AAMI ISO 11663 : 2009 QUALITY OF DIALYSIS FLUID FOR HAEMODIALYSIS AND RELATED THERAPIES
DIN EN ISO 11663:2016-02 QUALITY OF DIALYSIS FLUID FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 11663:2014)

AAMI RD5 : 2003 HEMODIALYSIS SYSTEMS
AAMI RD62 : 2006 WATER TREATMENT EQUIPMENT FOR HEMODIALYSIS APPLICATIONS
AAMI RD61 : 2006 CONCENTRATES FOR HEMODIALYSIS

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