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AAMI ISO 13958 : 2009

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by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 AND RELATED THERAPIES

Available format(s)

Hardcopy , PDF

Superseded date

30-09-2014

Superseded by

AAMI 13958 : 2014

Language(s)

English

Published date

01-01-2009

€101.40
Excluding VAT

Glossary of equivalent standards
Committee representation
Background of US adoption of ISO 13958:2009
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Tests
6 Labeling
Annex A (informative) - Rationale for the development and
                        provisions of this International
                        Standard
Bibliography

Describes minimum requirements for concentrates used for hemodialysis and related therapies.

Committee
RD
DevelopmentNote
Supersedes AAMI RD61. (06/2011)
DocumentType
Standard
Pages
37
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy
Supersedes

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 23500:2014 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
ISO 13959:2014 Water for haemodialysis and related therapies
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied

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