UNI EN ISO 14161 : 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
27-08-2022
01-01-2009
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General
5 Characteristics of biological indicators
5.1 General
5.2 Test organism suspension for direct inoculation of
products
5.3 Inoculated carriers
5.4 Self-contained biological indicators
5.5 Other biological indicators
6 Selection of supplier
6.1 General
6.2 Documentation
7 Biological indicators in process development
7.1 General
7.2 Overkill approach
7.3 Combined biological indicator and bioburden method
7.4 Bioburden method
8 Biological indicators in sterilization validation
8.1 General
8.2 Placement and handling of biological indicators
8.3 Sterilizer qualification
8.4 Performance qualification
8.5 Review and approval of validation
8.6 Requalification
9 Biological indicators in routine monitoring
9.1 General
9.2 Placement and handling of biological indicators
9.3 Process challenge device (PCD)
10 Results
10.1 General
10.2 Interpretation of results
11 Application of biological indicator standards
11.1 General assessment of biological indicator
performance by the user
11.2 Nominal population of test organism
11.3 Resistance determination
11.4 z value determination
11.5 F(T, z) equivalent sterilization value determination
11.6 Establishing spore-log-reduction (SLR)
11.7 Sterility assurance level (SAL) calculation
11.8 Test equipment
12 Culture conditions
12.1 General
12.2 Incubation temperature
12.3 Incubation period
12.4 Choice of growth medium
13 Third-party requirements
13.1 General
13.2 Minimum requirements for replicates and total number
of biological indicators
13.3 Test equipment
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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