DIN EN 13867:2003-01

Name: DIN EN 13867:2003-01
Brand: DIN

Superseded

View Superseded by

CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES

Available format(s)

Hardcopy , PDF

Superseded date

01-03-2016

Language(s)

English

Published date

01-01-2003

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Labelling and documentation requirements
6 Test methods
Annex A (informative) - Examples of analytical methods
Annex ZA (informative) Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC
         'Medical Devices'
Annex ZB (informative) A-deviations
Bibliography

Defines requirements for dry and liquid concentrates to be diluted for use as dialysing fluids in haemodialysis or related therapies.

DocumentType	Standard
Pages	14
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Superseded
SupersededBy	DIN EN ISO 13958 E : 2016

Standards	Relationship
NBN EN 13867 : 2002 + A1 2009	Identical
NS EN 13867 : 2002 + A1 2009	Identical
EN 13867:2002+A1:2009	Identical
BS EN 13867 : 2002	Identical
UNI EN 13867 : 2009	Identical
SN EN 13867 : 2002 + A1 2009	Identical
NEN EN 13867 : 2002 + A1 2009	Identical
I.S. EN 13867:2002	Identical
UNE-EN 13867:2003	Identical
NF EN 13867 : 2003 + A1 2009	Identical

EN 556:1994 + A1:1998	STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
EN 1174-3 : 1996	STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - GUIDE TO THE METHODS FOR VALIDATION OF MICROBIOLOGICAL TECHNIQUES
EN 1174-1 : 1996	STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - REQUIREMENTS
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
EN 1174-2 : 1996	STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - GUIDANCE
EN 980:2008	Symbols for use in the labelling of medical devices