I.S. 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - PART 3: GUIDE TO THE METHODS FOR VALIDATION OF MICROBIOLOGICAL TECHNIQUES
Hardcopy , PDF
16-06-2006
English
01-01-1997
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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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
Gives guidance by describing approaches which may be taken when validating techniques for bioburden estimation.
| DocumentType |
Standard
|
| Pages |
20
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NF EN 1174-3 : 1997 | Identical |
| NS EN 1174-3 : 1ED 1997 | Identical |
| NEN EN 1174-3 : 1997 | Identical |
| UNE-EN 1174-3:1997 | Identical |
| EN 1174-3 : 1996 | Identical |
| NBN EN 1174-3 : 1997 | Identical |
| UNI EN 1174-3 : 1998 | Identical |
| BS EN 1174-3:1997 | Identical |
| SN EN 1174-3 : 1997 | Identical |
| DIN EN 1174-3:1997-02 | Identical |
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