AAMI ISO 23500 : 2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HEMODIALYSIS AND RELATED THERAPIES
Hardcopy , PDF
30-09-2014
English
01-01-2011
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Glossary of equivalent standards
Committee representation
Background of US adoption of ISO 23500:2011
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Summary of quality requirements of ISO 13958,
ISO 13959 and ISO 11663
5 Critical aspects of system design
6 Validation of system performance
7 Quality management
8 Strategies for microbiological control
9 Environment
10 Personnel
Annex A (informative) - Rationale for the development
and provisions of this
International Standard
Annex B (informative) - Equipment
Annex C (informative) - Monitoring guidelines for water
treatment equipment, distribution
systems and dialysis fluid
Annex D (informative) - Strategies for microbiological
control
Annex E (informative) - Validation
Annex F (informative) - Special considerations for home
hemodialysis
Annex G (informative) - Special considerations for
acute hemodialysis
Bibliography
Gives dialysis practitioners with guidance on the preparation of dialysis fluid for hemodialysis and related therapies and substitution fluid for use in online therapies, such as hemodiafiltration and hemofiltration.
| Committee |
WG 05
|
| DevelopmentNote |
Supersedes AAMI RD52. (06/2011)
|
| DocumentType |
Standard
|
| Pages |
105
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| AAMI TIR58 : 2014 | WATER TESTING METHODOLOGIES |
| ISO 11663:2014 | Quality of dialysis fluid for haemodialysis and related therapies |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO 13958:2014 | Concentrates for haemodialysis and related therapies |
| ISO 26722:2014 | Water treatment equipment for haemodialysis applications and related therapies |
| IEC 60529:1989+AMD1:1999+AMD2:2013 CSV | Degrees of protection provided by enclosures (IP Code) |
| ISO 13959:2014 | Water for haemodialysis and related therapies |
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