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BS EN 1174-3:1997

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Sterilization of medical devices. Estimation of the population of micro-organisms on product Guide to the methods for validation of microbiological techniques

Available format(s)

Hardcopy , PDF

Superseded date

04-28-2006

Language(s)

English

Published date

07-15-1997

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
CH/198
DevelopmentNote
Reviewed and confirmed by BSI, March, 2005. (03/2005) Supersedes 94/506240 DC. (08/2005)
DocumentType
Standard
Pages
14
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
NEN EN 1174-3 : 1997 Identical
UNE-EN 1174-3:1997 Identical
I.S. EN 1174-3:1997 Identical
EN 1174-3 : 1996 Identical
UNI EN 1174-3 : 1998 Identical
SN EN 1174-3 : 1997 Identical
NF EN 1174-3 : 1997 Identical
NS EN 1174-3 : 1ED 1997 Identical
NBN EN 1174-3 : 1997 Identical
DIN EN 1174-3:1997-02 Identical

BS EN 1174-1:1996 Sterilization of medical devices. Estimation of the population of micro-organisms on product Requirements
EN 1174-2 : 1996 STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - GUIDANCE

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