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EN 1174-3 : 1996

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - GUIDE TO THE METHODS FOR VALIDATION OF MICROBIOLOGICAL TECHNIQUES

Published date

12-01-2013

Superseded date

01-04-2018

Superseded by

EN ISO 11737-1:2018

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Summarise this standard

Introduction
1 Scope
2 Normative reference
3 Definitions
4 Validation of the technique for removal of
    micro-organisms from product
5 Evaluation of culture conditions
6 Screening for the release of substances adversely
    affecting bioburden estimates
Annexes
A (informative) Worked examples to illustrate the
    calculation of correction factors
B (informative) Bibliography
ZA (informative) Clauses of this European Standard
         addressing essential requirements or other provisions
         of EU Directives

Describes approaches for validation techniques for bioburden estimation. Not intended as an exhaustive guide but for highlighting of important aspects of methodology requiring attention. Designed to be informative but does not specify requirements.

Committee
TC 204
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

Standards Relationship
NEN EN 1174-3 : 1997 Identical
I.S. EN 1174-3:1997 Identical
BS EN 1174-3:1997 Identical
NF EN 1174-3 : 1997 Identical
NS EN 1174-3 : 1ED 1997 Identical
AS EN 1174.3-2002 Identical
NBN EN 1174-3 : 1997 Identical
DIN EN 1174-3 E : 1997 Identical
DIN EN 1174-3:1997-02 Identical
UNE-EN 1174-3:1997 Identical

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