ISO 11138-7:2019
Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results
This document provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes.
It does not consider those processes that rely solely on physical removal of microorganisms, e.g. filtration.
It is not applicable to combination processes using, for example, washer-disinfectors or flushing and steaming of pipelines.
It does not specify requirements for the selection and use of biological indicators intended to monitor vaporised hydrogen peroxide processes for isolator and room biodecontamination processes at atmospheric pressure.
It is not applicable to liquid immersion sterilization processes.
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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
6 Selection of supplier
6.1 General
6.2 Documentation
6.2.1 General
6.2.2 Manufacturer audit
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
10 Interpretation and acceptance criteria
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
11.3.1 General
11.3.2 Survivor curve method
11.3.3 Fraction-negative method
11.3.4 Survival-kill response characteristics
11.4 z value determination
11.4.1 General
11.4.2 Graphically plotting the z value
11.4.3 Mathematically calculating the z value
11.4.4 Correlation coefficient, r, for the z value
11.5 F(T, z) equivalent sterilization value determination
11.6 Establishing spore-log-reduction
11.7 Sterility assurance level 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 considerations
13.1 General
13.2 Minimum requirements from ISO 11138-1 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 D value determination by fraction-negative method
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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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
6 Selection of supplier
6.1 General
6.2 Documentation
6.2.1 General
6.2.2 Manufacturer audit
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
10 Interpretation and acceptance criteria
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
11.3.1 General
11.3.2 Survivor curve method
11.3.3 Fraction-negative method
11.3.4 Survival-kill response characteristics
11.4 z value determination
11.4.1 General
11.4.2 Graphically plotting the z value
11.4.3 Mathematically calculating the z value
11.4.4 Correlation coefficient, r, for the z value
11.5 F(T, z) equivalent sterilization value determination
11.6 Establishing spore-log-reduction
11.7 Sterility assurance level 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 considerations
13.1 General
13.2 Minimum requirements from ISO 11138-1 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 D value determination by fraction-negative method
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