15/30321502 DC : 0
Superseded
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BS EN ISO 11138-1 - STERILIZATION OF HEALTH PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
Hardcopy , PDF
English
30-04-2017
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
5 Specific manufacturing requirements
6 Determination of resistance
7 Culture conditions
Annex A (normative) - Determination of viable
count
Annex B (normative) - Determination of growth
inhibition by carriers and primary packaging
materials exposed to sterilization processes
Annex C (normative) - D value determination by
survivor curve method
Annex D (normative) - D value determination by
fraction negative method
Annex E (normative) - Survival-kill response
characteristics
Annex F (informative) - Relationship between
components of biological indicators
Bibliography
BS EN ISO 11138-1.
| Committee |
CH/198
|
| DocumentType |
Draft
|
| Pages |
50
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
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