BS EN 1174-3:1997
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Sterilization of medical devices. Estimation of the population of micro-organisms on product Guide to the methods for validation of microbiological techniques
Hardcopy , PDF
28-04-2006
English
15-07-1997
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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Superseded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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