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DIN EN ISO 13958 E : 2016

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13958:2014)
Available format(s)

Hardcopy , PDF

Superseded date

01-30-2021

Language(s)

English

Published date

01-01-2016

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

National foreword
National Annex NA (informative) - Bibliography
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
Annex ZA (informative) - Relationship between this
         European Standard and the Essential Requirements
         of EU Directive 93/42/EEC on medical devices
Bibliography

Defines minimum requirements for concentrates used for haemodialysis and related therapies.

DevelopmentNote
Supersedes DIN EN 13867 E. (05/2016)
DocumentType
Standard
Pages
36
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
EN ISO 13958:2015 Identical
ISO 13958:2014 Identical

ISO 11663:2014 Quality of dialysis fluid for haemodialysis and related therapies
DIN EN ISO 11663 E : 2016 QUALITY OF DIALYSIS FLUID FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 11663:2014)
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN ISO 13959:2015 Water for haemodialysis and related therapies (ISO 13959:2014)
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
DIN EN ISO 13959 E : 2016 WATER FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13959:2014)
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
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
DIN EN 61010-1 : 2011 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS
EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
ISO 14971:2007 Medical devices Application of risk management to medical devices
EN ISO 11663:2015 Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014)
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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Hardcopy - English
PDF - English
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