BS EN ISO 13958:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 haemodialysis and related therapies
Hardcopy , PDF
English
31-12-2015
27-03-2019
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Superseded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 |
| I.S. EN ISO 13958:2015 | Equivalent |
| 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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