17/30363625 DC : DRAFT SEP 2017
Current
The latest, up-to-date edition.
BS EN ISO 11138-7 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 7: GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
26-09-2017
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General
5 Characteristics of biological indicators
6 Selection of supplier
7 Biological indicators in process development
8 Biological indicators in sterilization validation
9 Biological indicators in routine monitoring
10 Results
11 Application of biological indicator standards
12 Culture conditions
13 Third-party requirements
14 Personnel training
15 Storage and handling
16 Disposal of biological indicators
Annex A (informative) - Microbiological inactivation
kinetics and enumeration techniques
Annex B (informative) - Process challenge devices
Annex C (informative) - Formulae for fraction-negative
methods for D value calculations
Annex D (informative) - Examples of documentation for
biological indicators prepared by the user
Annex E (informative) - Calculation of z value
Annex F (informative) - D value determination by survivor
curve method
Annex G (informative) - Survival-kill response characteristics
Bibliography
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