I.S. EN ISO 13958:2015
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13958:2014)
Hardcopy , PDF
30-09-2019
English
20-12-2015
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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National Foreword
European foreword
Foreword
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
Annex ZA (informative) - Relationship between
this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on
medical devices
Provides minimum requirements for concentrates used for haemodialysis and related therapies.
| DevelopmentNote |
Supersedes I.S. EN 13867. (01/2016)
|
| DocumentType |
Standard
|
| Pages |
46
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| EN ISO 13958:2015 | Identical |
| ISO 13958:2014 | Identical |
| 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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