AAMI 13958 : 2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
Hardcopy , PDF
15-06-2015
English
15-08-2014
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Glossary of equivalent standards
Committee representation
US deviation to ISO 13958:2014
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Tests
6 Labelling
Annex A (informative) - Rationale for the development
and provisions of this International Standard
Bibliography
Defines minimum requirements for concentrates used for hemodialysis and related therapies.
| Committee |
WG 5
|
| DevelopmentNote |
Supersedes AAMI ISO 13958. (10/2014)
|
| DocumentType |
Standard
|
| ISBN |
1-57020-548-5
|
| Pages |
37
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| AAMI TIR72 : 2017 | DIALYSIS FLUID CHEMICAL COMPOSITION |
| 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 14971:2007 | Medical devices Application of risk management to medical devices |
| 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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