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AAMI ISO 23500 : 2011

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HEMODIALYSIS AND RELATED THERAPIES
Available format(s)

Hardcopy , PDF

Superseded date

30-09-2014

Language(s)

English

Published date

01-01-2011

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Superseded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
IEC 60601-2-16 : 4.0 MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT
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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