NBN EN ISO 11138-1 : 2006
Current
The latest, up-to-date edition.
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
12-01-2013
Foreword
Introduction
1 Scope
1.1 General
1.2 Exclusions
2 Normative references
3 Terms and definitions
4 General manufacturing requirements
4.1 Manufacturing controls
4.2 Test organism
4.3 Information supplied by manufacturer (labelling)
4.4 Storage and transport
5 Specific manufacturing requirements
5.1 Suspensions
5.2 Carrier, primary and secondary packaging
5.3 Inoculated carrier
5.4 Biological indicators
5.5 Self-contained biological indicators
6 Determination of resistance
6.1 General resistance requirements
6.2 Test organism
6.3 Population of test organisms
6.4 Resistance characteristics
6.5 Test conditions
7 Culture conditions
7.1 Incubator
7.2 Growth medium
7.3 Incubation
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
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