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STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
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Superseded date: 17-09-2021
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Published date: 12-01-2013
Publisher: Swiss Standards
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
This standard 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 sterlization processes.
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