I.S. EN 1174-2:1997
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 - PART 2: GUIDANCE
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 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
Provides guidance on the implementation of the requirements specified in I.S. EN 1174-1.
| DocumentType |
Standard
|
| Pages |
36
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| UNI EN 1174-2 : 1998 | Identical |
| BS EN 1174-2:1997 | Identical |
| NS EN 1174-2 : 1ED 1997 | Identical |
| NEN EN 1174-2 : 1997 | Identical |
| UNE-EN 1174-2:1997 | Identical |
| NF EN 1174-2 : 1997 | Identical |
| EN 1174-2 : 1996 | Identical |
| SN EN 1174-2 : 1997 | Identical |
| NBN EN 1174-2 : 1997 | Identical |
| DIN EN 1174-2:1997-02 | Identical |
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