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BS EN 1174-2:1997

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Guidance
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Superseded date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 General
    4.1 Operation of the laboratory
    4.2 Equipment and materials
    4.3 Microbiological media
5 Selection of technique
    5.1 General
    5.2 Elements of bioburden estimation
    5.3 Selection of media and incubation conditions
6 Validation of bioburden techniques
    6.1 General
    6.2 Validation of technique for removal of micro-
          organisms
    6.3 Validation of enumeration methods
7 Use of technique
    7.1 General
    7.2 Limit setting for process monitoring
    7.3 Trend analysis for process monitoring
    7.4 Sampling frequency for process monitoring
Annex A (informative) Bibliography
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or other provisions
of EU Directives

Gives guidelines on implementing requirements defined in EN 1174-1, to provide a better understanding in addition to giving assistance in implementation of its requirements. Intended not as an exhaustive guide, but to show important aspects requiring attention. Not intended to be a checklist for assessment of compliance with EN 1174-1.

Committee
CH/198
DevelopmentNote
Reviewed and confirmed by BSI, March, 2005. (03/2005)
DocumentType
Standard
Pages
20
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
NBN EN 1174-2 : 1997 Identical
NEN EN 1174-2 : 1997 Identical
NF EN 1174-2 : 1997 Identical
SN EN 1174-2 : 1997 Identical
I.S. EN 1174-2:1997 Identical
NS EN 1174-2 : 1ED 1997 Identical
UNE-EN 1174-2:1997 Identical
EN 1174-2 : 1996 Identical
UNI EN 1174-2 : 1998 Identical
DIN EN 1174-2:1997-02 Identical

EN 1174-1 : 1996 STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - REQUIREMENTS

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US$170.10
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