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AAMI RD62 : 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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

WATER TREATMENT EQUIPMENT FOR HEMODIALYSIS APPLICATIONS

Available format(s)

Hardcopy , PDF

Superseded date

22-03-2011

Language(s)

English

Published date

01-01-2009

Glossary of equivalent standards
Committee representation
Foreword
1 Scope
  1.1 General
  1.2 Inclusions
  1.3 Exclusions
2 Normative references
3 Terms and definitions
4 Requirements
  4.1 Product water quality requirements
      4.1.1 Water bacteriology
      4.1.2 Maximum level of chemical contaminants
  4.2 Water treatment equipment requirements
      4.2.1 General
      4.2.2 Materials compatibility
      4.2.3 Disinfection protection
      4.2.4 Safety requirements
      4.2.5 Regenerated or reconstituted devices
      4.2.6 Deionization
      4.2.7 Reverse osmosis
      4.2.8 Filters
      4.2.9 Carbon adsorption media
      4.2.10 Automatically regenerated water softeners
      4.2.11 Storage tanks
      4.2.12 Endotoxin-retentive filters
      4.2.13 Ultraviolet irradiators
      4.2.14 Hot water disinfection systems
      4.2.15 Ozone disinfection systems
      4.2.16 Tempering valves
      4.2.17 Piping systems
      4.2.18 Backflow prevention device
5 Tests
  5.1 Compliance with product water quality requirements
      5.1.1 Water bacteriology
      5.1.2 Maximum level of chemical contaminants
  5.2 Compliance with water treatment equipment requirements
      5.2.1 General
      5.2.2 Materials compatibility
      5.2.3 Disinfection protection
      5.2.4 Safety requirements
      5.2.5 Regenerated or reconstituted devices
      5.2.6 Deionization
      5.2.7 Reverse osmosis
      5.2.8 Filters
      5.2.9 Carbon adsorption media
      5.2.10 Automatically regenerated water softeners
      5.2.11 Storage tanks
      5.2.12 Endotoxin-retentive filters
      5.2.13 Ultraviolet irradiators
      5.2.14 Hot water disinfection systems
      5.2.15 Ozone disinfection systems
      5.2.16 Tempering valves
      5.2.17 Piping systems
      5.2.18 Backflow prevention devices
6 Labeling
  6.1 Device markings
  6.2 Product literature
Annex
A - Rationale for the development and provisions of this standard
Bibliography

Describes devices used to treat water intended for use in the delivery of hemodialysis. Included in the scope of the standard is water used for: (1) the preparation of concentrates from powder at a dialysis facility, (2) the preparation of dialysate, and (3) the reprocessing of dialyzers for multiple use.

Committee
WG 04
DocumentType
Standard
Pages
42
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy

AAMI RD52 : 2004 : R2010 DIALYSATE FOR HEMODIALYSIS
AAMI TIR58 : 2014 WATER TESTING METHODOLOGIES
AAMI RD52 : 2004 DIALYSATE FOR HEMODIALYSIS
AAMI RD47 : 2008 REPROCESSING OF HEMODIALYZERS
AAMI TIR 43 : 2011 ULTRAPURE DIALYSATE FOR HEMODIALYSIS AND RELATED THERAPIES
AAMI RD5 : 2003 HEMODIALYSIS SYSTEMS
AAMI RD52 : 2004 : INC : AMD 1 : 2007 : AMD 2 : 2007 : AMD 3 : 2009 : AMD 4 : 2009 DIALYSATE FOR HEMODIALYSIS
AAMI RD61 : 2006 CONCENTRATES FOR HEMODIALYSIS

AAMI RD5 : 2003 HEMODIALYSIS SYSTEMS

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