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BS EN 13867 : 2002

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

Available format(s)

Hardcopy , PDF

Superseded date

31-12-2015

Language(s)

English

Published date

01-01-2002

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

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

Committee
CH/150/2
DevelopmentNote
Supersedes 00/560946 DC (12/2002) 2002 Edition Re-Issued in January 2010 & incorporates AMD 1 2009. (01/2010)
DocumentType
Standard
Pages
18
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

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

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