SN EN ISO 15882:2008
Current
The latest, up-to-date edition.
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
Hardcopy
German - English
12-01-2008
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General considerations
5 Classes of chemical indicators
5.1 General
5.2 Class 1: Process indicators
5.3 Class 2: Indicators for use in specific
tests
5.4 Class 3: Single-parameter indicators
5.5 Class 4: Multi-parameter indicators
5.6 Class 5: Integrating indicators
5.7 Class 6: Emulating indicators
6 Selection of chemical indicators
7 Use of chemical indicators
7.1 External chemical indicators
7.2 Internal chemical indicators
7.3 Indicators for specific test procedures
7.4 Indicators for use with process challenge
devices
8 Interpretation of chemical indicators
8.1 General
8.2 Chemical indicator responses
8.3 Chemical indicators showing "Fail" response
9 Chemical indicators in sterility assurance
procedures
9.1 General
9.2 Record keeping
10 Labelling of chemical indicators
11 Personnel training
12 Storage and handling
Annex A (informative) Background information on the
Bowie-Dick test
Bibliography
Defines guidance for the selection, use and interpretation of results of chemical indicators used in process definition, validation, and routine monitoring and control of sterilization processes.
| Committee |
INB/NK 171
|
| DocumentType |
Standard
|
| Pages |
0
|
| PublisherName |
Swiss Standards
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 15882:2008 | Identical |
| BS EN ISO 15882:2008 | Identical |
| ISO 15882:2008 | Identical |
| UNE-EN ISO 15882:2009 | Identical |
| NF EN ISO 15882 : 2010 | Identical |
| NEN EN ISO 15882 : 2008 | Identical |
| NS EN ISO 15882 : 2ED 2008 | Identical |
| I.S. EN ISO 15882:2008 | Identical |
| UNI EN ISO 15882 : 2009 | Identical |
| NBN EN ISO 15882 : 2008 | Identical |
| DIN EN ISO 15882:2008-12 | Identical |
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