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BS EN ISO 13958:2015

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Concentrates for haemodialysis and related therapies

Available format(s)

Hardcopy , PDF

Superseded date

27-03-2019

Language(s)

English

Published date

31-12-2015

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.

Committee
CH/150/2
DevelopmentNote
Supersedes BS EN 13867 & 13/30270468 DC. (12/2015)
DocumentType
Standard
Pages
40
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 13958:2014 Identical
EN ISO 13958:2015 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
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 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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£232.00
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