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SN EN ISO 14161 : 2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
17-09-2021
12-01-2013
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 Biological indicators
6 Selection of supplier
6.1 General
6.2 Documentation
7 Biological indicators in process
development
7.1 General
7.2 Reference microorganism method
7.3 Combined biological indicator and
bioburden method
7.4 Bioburden method
8 Biological indicators in sterlization
validation
8.1 General
8.2 Placement and handling of biological
indicators
8.3 Sterlizer qualification
8.4 Performance qualification
8.5 Review and approval of validation
8.6 Requalifications
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 D-value determination
11.4 Testing equipment
12 Culture conditions
12.1 General
12.2 Incubation temprature
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 of biological indicators
collected by the user
Bibliography
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